Consolidated Guidance 

about Materials Licenses

Applications for Sealed Source and

Device Evaluation and Registration

Draft Report for Comment

Office of Federal and State Materials and

Environmental Management Programs

NUREG-1556

Volume 3, Rev. 2
NRC Reference Material 

As of November 1999, you may electronically access 

NUREG-series publications and other NRC records at 

NRC’s Public Electronic Reading Room at 

http://www.nrc.gov/reading-rm.html. Publicly released 

records include, to name a few, NUREG-series 

publications; Federal Register notices; applicant, 

licensee, and vendor documents and correspondence; 

NRC correspondence and internal memoranda; bulletins 

and information notices; inspection and investigative 

reports; licensee event reports; and Commission papers 

and their attachments. 

NRC publications in the NUREG series, NRC 

regulations, and Title 10, “Energy,” in the Code of

Federal Regulations may also be purchased from one 

of these two sources. 

1. The Superintendent of Documents

 U.S. Government Printing Office

Mail Stop SSOP

Washington, DC 20402–0001

Internet: bookstore.gpo.gov

Telephone: 202-512-1800

Fax: 202-512-2250 

2. The National Technical Information Service 

Springfield, VA 22161–0002

www.ntis.gov

1–800–553–6847 or, locally, 703–605–6000 

A single copy of each NRC draft report for comment is 

available free, to the extent of supply, upon written 

request as follows:

Address: U.S. Nuclear Regulatory Commission

 Office of Administration 

Publications Branch

 Washington, DC 20555-0001

E-mail: DISTRIBUTION.RESOURCE@NRC.GOV

Facsimile: 301–415–2289 

Some publications in the NUREG series that are 

posted at NRC’s Web site address 

http://www.nrc.gov/reading-rm/doc-collections/nuregs 

are updated periodically and may differ from the last 

printed version. Although references to material found on 

a Web site bear the date the material was accessed, the 

material available on the date cited may subsequently be 

removed from the site.

Non-NRC Reference Material 

Documents available from public and special technical 

libraries include all open literature items, such as books, 

journal articles, transactions, Federal Register notices, 

Federal and State legislation, and congressional reports. 

Such documents as theses, dissertations, foreign reports 

and translations, and non-NRC conference proceedings 

may be purchased from their sponsoring organization. 

Copies of industry codes and standards used in a 

substantive manner in the NRC regulatory process are 

maintained at—

The NRC Technical Library

Two White Flint North

11545 Rockville Pike

Rockville, MD 20852–2738 

These standards are available in the library for reference 

use by the public. Codes and standards are usually 

copyrighted and may be purchased from the originating 

organization or, if they are American National Standards, 

from—

American National Standards Institute

11 West 42nd Street

New York, NY 10036–8002

www.ansi.org

212–642–4900 

AVAILABILITY OF REFERENCE MATERIALS

IN NRC PUBLICATIONS

Legally binding regulatory requirements are stated only 

in laws; NRC regulations; licenses, including technical 

specifications; or orders, not in NUREG-series 

publications. The views expressed in contractorprepared publications in this series are not necessarily 

those of the NRC.

The NUREG series comprises (1) technical and 

administrative reports and books prepared by the staff 

(NUREG–XXXX) or agency contractors (NUREG/CR–

XXXX), (2) proceedings of conferences (NUREG/CP–

XXXX), (3) reports resulting from international 

agreements (NUREG/IA–XXXX), (4) brochures 

(NUREG/BR–XXXX), and (5) compilations of legal 

decisions and orders of the Commission and Atomic and 

Safety Licensing Boards and of Directors’ decisions

under Section 2.206 of NRC’s regulations (NUREG–

0750).

DISCLAIMER: This report was prepared as an account 

of work sponsored by an agency of the U.S. 

Government. Neither the U.S. Government nor any 

agency thereof, nor any employee, makes any warranty, 

expressed or implied, or assumes any legal liability or 

responsibility for any third party’s use, or the results of 

such use, of any information, apparatus, product, or 

process disclosed in this publication, or represents that 

its use by such third party would not infringe privately 

owned rights.
Consolidated Guidance 

about Materials Licenses

Applications for Sealed Source and

Device Evaluation and Registration

Draft Report for Comment

Manuscript Completed: April 2013

Date Published: May 2013

Prepared by: 

J. Jankovich

M. LaFranzo

R. Rogus

L. Sepulveda

K. Von Ahn

Office of Federal and State Materials and

 Environmental Management Programs

 

NUREG-1556

Volume 3, Rev. 2
COMMENTS ON DRAFT REPORT

Any interested party may submit comments on this report for consideration by the NRC staff. 

Comments may be accompanied by additional relevant information or supporting data. Please 

specify the report number NUREG-1556, Volume 3, Revision 2, in your comments, and send 

them by the end of the comment period specified in the Federal Register notice announcing the 

availability of this report. 

Addresses: You may submit comments by any one of the following methods. Please include 

Docket ID NRC-2013-0104 in the subject line of your comments. Comments submitted in 

writing or in electronic form will be posted on the NRC website and on the Federal rulemaking 

website http://www.regulations.gov. 

Federal Rulemaking Website: Go to http://www.regulations.gov and search for documents 

filed under Docket ID NRC-2013-0104. Address questions about NRC dockets to Carol 

Gallagher at 301-492-3668 or by e-mail at Carol.Gallagher@nrc.gov.

Mail comments to: Cindy Bladey, Chief, Rules, Announcements, and Directives Branch

(RADB), Division of Administrative Services, Office of Administration, Mail Stop: 

TWB-05-B01M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Faxes 

may be sent to RADB at 301-492-3446.

For any questions about the material in this report, please contact: Tomas Herrera, Sr. Project 

Manager at 301-415-7138 or by e-mail at Tomas.Herrera@nrc.gov.

Please be aware that any comments that you submit to the NRC will be considered a public 

record and entered into the Agencywide Documents Access and Management System 

(ADAMS). Do not provide information you would not want to be publicly available.
iii

ABSTRACT

This technical report is designed to provide guidance to applicants for requests for a sealed 

source or device safety evaluations and registrations. It also provides the U.S. Nuclear 

Regulatory Commission (NRC) reviewers of such requests with the information and materials 

necessary to determine that the products are acceptable for licensing purposes. It provides the 

applicants and reviewers with information concerning how to file a request, a listing of the 

applicable regulations and industry standards, policies affecting evaluation and registration, 

administrative procedures to be followed, information on how to perform the evaluation and 

write a registration certificate, and the responsibilities of the registration certificate holder.

Paperwork Reduction Act Statement

This NUREG contains information collection requirements that are subject to the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved 

by the Office of Management and Budget (OMB), approval numbers 3150-0014, 3150-0035, 

3150-0017, 3150-0016, 3150-0001, 3150-0007, 3150-0010, 3150-0158, 3150-0130, and 3150-

0008.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for 

information or an information collection requirement unless the requesting document displays a

currently valid OMB control number.

Public Protection Notification

v

FOREWORD

The U.S. Nuclear Regulatory Commission’s (NRC’s) NUREG-1556 technical report series 

provides a comprehensive source of reference information about various aspects of materials 

licensing and materials program implementation. These reports, where applicable, describe a 

risk-informed, performance-based approach to licensing consistent with the current regulations. 

The reports are intended for use by applicants, licensees, license reviewers, and other NRC 

personnel. The NUREG-1556 series currently includes the following volumes:

Volume No. Volume Title

1 Program-Specific Guidance about Portable Gauge Licenses

2 Program-Specific Guidance about Industrial Radiography Licenses

3 Applications for Sealed Source and Device Evaluation and Registration

4 Program-Specific Guidance about Fixed Gauge Licenses

5 Program-Specific Guidance about Self-Shielded Irradiator Licenses

6 Program-Specific Guidance about 10 CFR Part 36 Irradiator Licenses

7 Program-Specific Guidance about Academic, Research and Development, and 

Other Licenses of Limited Scope Including Gas Chromatographs and X-Ray 

Fluorescence Analyzers

8 Program-Specific Guidance about Exempt Distribution Licenses

9 Program-Specific Guidance about Medical Use Licenses

10 Program-Specific Guidance about Master Materials Licenses

11 Program-Specific Guidance about Licenses of Broad Scope

12 Program-Specific Guidance about Possession Licenses for Manufacturing and 

Distribution

13 Program-Specific Guidance about Commercial Radiopharmacy Licenses

14 Program-Specific Guidance about Well Logging, Tracer, and Field Flood Study 

Licenses

15 Guidance about Changes of Control and about Bankruptcy Involving Byproduct, 

Source, or Special Nuclear Materials Licenses

16 Program-Specific Guidance about Licenses Authorizing Distribution to General 

Licensees
vi

Volume No. Volume Title

17 Program-Specific Guidance about Special Nuclear Material of Less Than 

Critical Mass Licenses

18 Program-Specific Guidance about Service Provider Licenses

19 Guidance for Agreement State Licensees about NRC Form 241 “Report of 

Proposed Activities in Non-Agreement States, Areas of Exclusive Federal 

Jurisdiction, or Offshore Waters” and Guidance for NRC Licensees Proposing to 

Work in Agreement State Jurisdiction (Reciprocity)

20 Program-Specific Guidance about Administrative Licensing Procedures

21 Program-Specific Guidance about Possession Licenses for Production of 

Radioactive Materials Using an Accelerator

22 Reserved

The current document, NUREG-1556, Volume 3, Revision 2, “Consolidated Guidance about 

Materials Licenses: Applications for Sealed Source and Device Evaluation and Registration,” is 

intended for use by applicants, licensees, and NRC staff. This revision provides a general 

update to the previous information contained in NUREG-1556, Volume 3, Revision 1, issued 

April 2004.

This report takes a risk-informed, performance-based approach to evaluating sealed source and 

device (SSDs). A team composed of staff from NRC Headquarters, NRC regional offices, and 

Agreement States prepared this document, drawing on their collective experience in radiation 

safety in general and as specifically applied to sealed source and devices designs, safety 

evaluations, and registrations.

NUREG-1556, Volume 3, Revision 2, is not a substitute for NRC regulations. The approaches 

and methods described in this report are provided for information only. Methods and solutions 

different from those described in this report may be acceptable if they include a basis for the 

staff to make the determinations needed to issue a registration certificate or continue a safety 

evaluation for a sealed source or device.

Brian J. McDermott, Director

Division of Materials Safety and State Agreements

Office of Federal and State Materials and Environmental Management Programs
vii

CONTENTS

ABSTRACT...............................................................................................................................iii

FOREWORD ..............................................................................................................................v

FIGURES AND TABLES...........................................................................................................xi

ACKNOWLEDGMENTS..........................................................................................................xiii

ABBREVIATIONS ....................................................................................................................xv

1. PURPOSE OF REPORT......................................................................................................1

2. AGREEMENT STATES .......................................................................................................3

3. MANAGEMENT RESPONSIBILITY.....................................................................................7

3.1 Commitments and Responsibilities...............................................................................7

 3.2 Safety Culture...............................................................................................................8

4. APPLICABLE REGULATIONS..........................................................................................11

4.1 Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 for 

Use by Persons Exempt from Licensing Requirements ..............................................13

 4.2 Gas and Aerosol Detectors Containing Byproduct Material for Use by Persons 

 Exempt from Licensing Requirements ........................................................................15

4.3 Industrial Gauges for Use by Persons Exempt from Licensing Requirements ............16

4.4 Devices Used under the General License in 10 CFR 31.5..........................................16

4.5 Luminous Safety Devices Used in Aircraft under 10 CFR 31.7...................................17

4.6 Ice Detection Devices Containing Strontium-90..........................................................18

4.7 Radiography Equipment .............................................................................................19

4.8 Well-Logging Equipment ............................................................................................20

4.9 Irradiators...................................................................................................................21

4.10 Sealed Sources and Devices for Medical Use ..........................................................22

5. GENERAL POLICIES AND PROCEDURES......................................................................25

5.1 Sealed Source and Device Designs that Do Not Require Evaluation and 

Registration ................................................................................................................25

 5.1.1 Calibration and Reference Sources.................................................................25

5.1.2 Products Used in Research and Development or by Broad Scope

 Licensees.......................................................................................................26

5.1.3 Custom Sealed Sources or Devices................................................................27

5.1.4 Items Containing Byproduct Material Listed in 10 CFR 30.15 .........................28

5.2 Custom Users.............................................................................................................28

5.3 As Low As Is Reasonably Achievable........................................................................28

5.4 Naturally Occurring or Accelerator-Produced Radioactive Material............................28

5.5 Foreign Vendors........................................................................................................29

5.6 Use of International or Foreign Standards .................................................................29

5.7 Medical Application—U.S. FDA-NRC Memorandum of Understanding......................30

5.8 Computer Software....................................................................................................30

5.9 Registration Certificate Revocation............................................................................31

5.10 Incidents...................................................................................................................31
viii

5.11 Proprietary Information .............................................................................................32

5.12 Identifying and Protecting Sensitive Information .......................................................33

5.13 Transportation ..........................................................................................................34

6. HOW TO FILE....................................................................................................................35

6.1 General/Format ..........................................................................................................35

6.2 Content.......................................................................................................................35

6.3 Engineering Drawings ................................................................................................36

7. WHERE TO FILE...............................................................................................................39

8. REGISTRATION FEES......................................................................................................41

9. DOCUMENT FLOW...........................................................................................................43

9.1 Application Receipt and Assignment to a Reviewer....................................................43

9.2 Expedited Reviews ....................................................................................................43

9.2.1 NRC-Expedited Reviews on the Basis of National Security .............................43

9.2.2 NRC-Expedited Reviews for Reasons Other than National Security ................44

9.3 Responsibilities of the Reviewer ................................................................................44

9.4 Inclusion in the Sealed Source and Device Computerized Registration System ........45

10. APPLICATION AND REVIEW PROCESS.........................................................................47

10.1 Summary Information ...............................................................................................47

10.1.1 Manufacturer and Distributor.........................................................................47

10.1.2 Custom User.................................................................................................48

10.1.3 Other Companies Involved............................................................................48

10.1.4 Model Number, Sealed Source or Device Type, and Principal Use Code .....48

10.1.5 Radionuclides Used in the Product ...............................................................49

10.1.6 Registration of Sources as Part of a Device..................................................49

10.1.7 Leak Test Frequency ....................................................................................49

10.1.8 Certificate and Signature of a Management Representative .........................50

10.2 Conditions of Use .....................................................................................................50

10.3 Construction of the Product ......................................................................................51

10.4 Labeling....................................................................................................................55

10.4.1 Devices.........................................................................................................55

10.4.2 Sealed Sources ............................................................................................55

10.5 Prototype Testing .....................................................................................................57

10.5.1 Sources ........................................................................................................59

10.5.2 Devices.........................................................................................................59

10.6 Radiation Profiles .....................................................................................................60

10.7 Quality Assurance and Quality Control ....................................................................62

10.8 Installation, Servicing, and Instructions to Users.......................................................65

10.9 Safety Evaluation and Concurrence .........................................................................67

11. DEFICIENCIES IN THE APPLICATIONS ..........................................................................69

11.1 Sending Deficiency Letters to Applicants..................................................................69

11.2 Meeting with Applicants............................................................................................70

11.3 Using the Telephone or Electronic Mail to Obtain Additional Information..................70
ix

11.4 Requesting Response Time Extensions ...................................................................70

12. CONTENTS OF THE CERTIFICATE .................................................................................71

12.1 Header .....................................................................................................................71

12.2 First Page Information ..............................................................................................71

12.3 Description ...............................................................................................................71

12.4 Labeling....................................................................................................................72

12.5 Diagrams..................................................................................................................72

12.6 Conditions of Normal Use.........................................................................................72

12.7 Prototype Testing .....................................................................................................72

12.8 External Radiation Levels.........................................................................................73

12.9 Quality Assurance and Quality Control .....................................................................73

12.10 Limitations and Other Considerations Of Use.........................................................73

12.11 Food and Drug Administration Approval Summary .................................................74

12.12 Safety Analysis Summary.......................................................................................74

12.13 References.............................................................................................................74

12.14 Issuing Agency .......................................................................................................74

12.15 Attachments ...........................................................................................................75

12.16 Dimensions and Use of Dual Units .........................................................................75

13. MODIFICATIONS TO EXISTING REGISTRATION CERTIFICATES.................................77

13.1 Amendments ............................................................................................................77

13.2 Corrections...............................................................................................................78

13.3 Combining Registration Certificates..........................................................................78

13.4 Transfers to Inactive Status......................................................................................78

13.5 Reactivating Inactive Registration Certificates ..........................................................80

13.6 Ownership Changes and Corporate Relocations ......................................................81

14. IDENTIFYING AND REPORTING DEFECTS AND NONCOMPLIANCE AS 

 REQUIRED BY 10 CFR PART 21 .....................................................................................83

15. GLOSSARY.......................................................................................................................85

APPENDICES

APPENDIX A APPLICATION AND REVIEW CHECKLIST .................................................A-1

APPENDIX B ASSIGNING REGISTRATION CERTIFICATE NUMBERS...........................B-1

APPENDIX C PRINCIPAL USE CODES AND DEFINITIONS ............................................C-1

APPENDIX D STANDARD REGISTRATION CERTIFICATE FORMATS ...........................D-1

APPENDIX E CHECKLIST FOR REQUESTS TO WITHHOLD INFORMAITON FROM

 PUBLIC DISCLOSURE................................................................................E-1

APPENDIX F INDUSTRY AND CONSENSUS STANDARDS............................................ F-1

APPENDIX G CHECKLIST FOR REVIEWING QUALITY ASSURANCE PROGRAMS.......G-1

APPENDIX H SAFETY CULTURE POLICY STATEMENT.................................................H-1

xi

FIGURES

Figure 2.1 U.S. map: locations of NRC offices and Agreement States......................................3

Figure 4.1 Watches and Aiming Sights ...................................................................................14

Figure 4.2 Smoke and Chemical Agent Detectors ..................................................................15

Figure 4.3 10 CFR 31.5 General License................................................................................17

Figure 4.4 10 CFR 31.7 General License................................................................................18

Figure 4.5 Radiography Equipment ........................................................................................19

Figure 4.6 Well-Logging Operations .......................................................................................21

Figure 4.7 Irradiators ..............................................................................................................22

Figure 5.1 Calibration and Reference Sources .......................................................................26

Figure 5.2 Packaging and Transportation ...............................................................................34

Figure 10.1 Radiation Profiles .................................................................................................61

Figure 10.2 Installation and Servicing of Devices ....................................................................66

TABLES

Table 2.1 Who Evaluates Sealed Sources and Devices? .......................................................4

Table 3.1 Traits of a Positive Safety Culture...........................................................................9

Table 10.1 Leak Test Requirements ......................................................................................50

Table 10.2 Design Requirements ...........................................................................................54

Table 10.3 Labeling Requirements.........................................................................................57

Table 10.4 Requirements for Prototype Testing .....................................................................60

Table 10.5 Requirements for Radiation Levels .......................................................................62

Table 10.6 Requirements for Quality Assurance and Quality Control .....................................64

Table 10.7 Requirements for Servicing Devices .....................................................................67

xiii

ACKNOWLEDGMENTS

The working group thanks the individuals listed below for assisting in the review and update of 

the report. All participants provided valuable insights, observations, and recommendations. 

The working group would like to thank the staff in the regional offices of the NRC and all of the 

States who provided comments and technical information that assisted in the development of 

this report. 

The working group also thanks Lisa Dimmick, John O’Donnell, Monica Orendi, Tara Weidner, 

and Duane White for developing the formatting and language used in many parts of the report. 

The Participants for this Revision

Bielecki, Jessica

Chidakel, Susan

Houseman, Esther

Jankovich, John J.

LaFranzo, Michael

Olmstead, Joan

Rogus, Ronald

Sepulveda, Lymari

Von Ahn, Karl

xv

ABBREVIATIONS

ADAMS Agencywide Documents Access and Management System

ALARA as low as is reasonably achievable

ANSI American National Standards Institute

ASQ American Society for Quality

Bq becquerel

CFR Code of Federal Regulations

Ci curie(s)

cm centimeter(s)

DCD Document Control Desk

DOT U.S. Department of Transportation

EPAct Energy Policy Act of 2005

FDA U.S. Food and Drug Administration

FR Federal Register

FSME Office of Federal and State Materials and Environmental Management Programs

GPO Government Printing Office

GBq gigabecquerel(s)

HDE humanitarian device exemption

hr hour

IAEA International Atomic Energy Agency

IDE investigational device exemption

in. inch(es)

IRB institutional review board

ISO International Organization of Standardization

MML Master Materials Licensee

MBq megabecquerel(s)

mCi millicurie(s)

MOU Memorandum of Understanding

mrem millirem

MSSA Division of Materials Safety and State Agreements

NARM Naturally Occurring Radioactive Material or Accelerator-Produced Radioactive 

Material

NORM Naturally Occurring Radioactive Material

NRC U.S. Nuclear Regulatory Commission

NSSDR National Sealed Source and Device Registry

OCFO Office of the Chief Financial Officer

PMA premarket approval

QA quality assurance

QC quality control

SSD sealed source and device

μCi microcurie(s)

U.S.C. United States Code

μSv microsievert(s)

1

1. PURPOSE OF REPORT

This technical report provides guidance to applicants on submitting requests to the U.S. Nuclear 

Regulatory Commission (NRC) for radiation safety evaluation and registration of sealed sources 

and devices containing byproduct material. In addition, it is designed to provide the reviewer of 

such requests for sealed source and device safety evaluations with the guidance, information, 

and materials necessary to make a determination that the product is acceptable for licensing 

purposes. The report provides the applicants and reviewers with information on how to file a 

request, a listing of the applicable regulations and industry standards, policies affecting 

evaluation and registration, administrative procedures to be followed, information on how to 

perform the evaluation and write a registration certificate, and the responsibilities of the 

registration certificate holder.

Radiation safety programs for the use of byproduct material as a sealed source or device are 

structured on the presumption that the byproduct material will not breach its containment and 

contaminate the environment or unnecessarily expose individuals to radiation. This 

presumption depends largely upon the adequacy of the containment properties of the sealed 

sources or devices in withstanding the stresses imposed by the environment in which they are 

possessed and used.

The NRC maintains the National Sealed Source and Device Registry (NSSDR) of radiation 

safety information on sealed sources and devices containing byproduct material. Agreement 

States also provide information on their radiation safety evaluations to the NRC for the registry. 

Both the NRC and the Agreement States use the information in the registry. Thus, a vendor 

needs to provide detailed information about its sealed source or device only to a single agency, 

and the results of the radiation safety evaluation will be available for use in granting licensing 

approval to users of the device throughout the United States.

Any information collection activities mentioned in this document are contained as requirements 

in Title 10 of the Code of Federal Regulations (10 CFR) Parts 2,19, 20, 21, 30, 31, 32, 34, 35, 

36, 39, 40, 70, 71, 110, 170, and 171, which provide the regulatory basis for this document. 

3

2. AGREEMENT STATES

Certain States, called Agreement States (see Figure 2.1), have entered into agreements with 

the NRC that give them the authority for certain activities, including performing safety 

evaluations of byproduct material, , which are used, possessed, or distributed by persons within

their borders. Any applicant, other than a Federal entity, who wishes to apply for an SSD 

registration certificate in one of these Agreement States should contact the responsible officials 

in that State for guidance on preparing an application. These applications should be filed with 

State officials, not with the NRC. In areas under exclusive federal jurisdiction within an

Agreement State, NRC continues to be the regulatory authority.

Figure 2.1 U.S. map: locations of NRC offices and Agreement States

In the special situation of work at Federally controlled sites in Agreement States, it is necessary 

to ascertain the jurisdictional status of the land to determine whether the NRC or the Agreement 

State has regulatory authority. These areas can also include tribal lands of federally recognized 

Indian Tribes.1

 The NRC has regulatory authority over land determined to be “exclusive Federal 

 1

 For the purposes of this guidance, an “Indian tribe” is defined as an Indian or Alaska Native tribe, band,

 nation, pueblo, village, or community that the Secretary of the Interior acknowledges to exist as an Indian tribe

 pursuant to the Federally Recognized Indian Tribe List Act of 1994. A list of federally recognized tribes is

 available at www.bia.gov.
4

jurisdiction,” while the Agreement State has jurisdiction over nonexclusive Federal jurisdiction 

land. Applicants are responsible for determining in advance the jurisdictional status of the 

specific areas where they plan to conduct licensed operations. The NRC recommends that 

applicants contact their local office of the Federal agency controlling the site (e.g., contract 

officer, base environmental health officer, district office staff) for assistance in determining the 

jurisdictional status of the land and to provide the information in writing to ensure compliance

with NRC or Agreement State regulatory requirements, as appropriate. Additional guidance on 

determining jurisdictional status is found in the Office of Federal and State Materials and 

Environmental Management Program’s (FSME) procedures in the State Agreement (SA) series, 

SA-500, “Jurisdiction Determination,” which is available at http://nrc-stp.ornl.gov/. Once on the 

Web site, use the link for “FSME Procedures” in the left hand column under “Resources & 

Tools.” The link will take you to another Web page where you can search for FSME 

Procedures.

Thirteen Agreement States (Arkansas, Iowa, Minnesota, New Jersey, New Mexico, North 

Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, Utah, Virginia, and Wisconsin) do not 

have authority to perform sealed source and device safety evaluations. The NRC regulates 

applicants and registration certificate holders located in these States in the same manner, with 

respect to sealed source and device registration, as those located in a non-Agreement State. 

Applicants from those Agreement States should contact the NRC’s Office of Federal and State

Materials and Environmental Management Programs.

Table 2.1 provides a quick way to evaluate whether the NRC or an Agreement State has 

regulatory authority.

Table 2.1 Who Evaluates Sealed Sources and Devices?

Applicant and Its Location Regulatory Agency

Distributor of products to persons exempt from licensing regardless of 

location

NRC

Federal agency regardless of location NRC

Non-Federal entity in non-Agreement State, District of Columbia, or U.S. 

territory or possession2

NRC

Non-Federal entity in Agreement State with authority to issue sealed 

source and device registry sheets 

Agreement State

Non-Federal entity in Agreement State that does not have authority to 

issue sealed source and device registry sheets

NRC 

Reference: A current list of Agreement States (including names, addresses, and telephone 

numbers of responsible officials) is available at the Office of Federal and State Materials and 

Environmental Management Programs’ public Web site, http://nrc-stp.ornl.gov. As an 

alternative, a request for the list can be made to an NRC regional office.

When an Agreement State issues a registration certificate, the State forwards a copy of the 

registration certificate to the NRC Division of Materials Safety and State Agreements (MSSA). 

 2 Entities should contact the NRC if they are located on tribal lands to determine jurisdiction.
5

MSSA performs an administrative review of each certificate, including an examination for gross 

errors or omissions and ensuring that the first page of the certificate contains all necessary 

information. The NRC incorporates the certificate into the NSSDR. If the NRC identifies any 

administrative problems or errors with an Agreement State registration certificate, the agency 

resolves them directly with the Agreement State.

Agreement State regulations may vary from NRC regulations. As such, SSDs registered by an 

Agreement State may have requirements that vary from those in NRC regulations, although the 

regulations are compatible. The NRC and Agreement States’ SSD programs are evaluated 

under the NRC’s Integrated Materials Performance Evaluation Program (IMPEP). The purpose 

of the evaluation is to ensure the State program is adequate to protect public health and safety 

compatible with the national program.

7

3. MANAGEMENT RESPONSIBILITY

The NRC recognizes that effective radiation safety program management is vital to achieving 

safe, secure, and compliant operations. Consistent compliance with NRC regulations provides 

reasonable assurance that licensed activities will be conducted safely and that effective 

management will result in increased safety, security, and compliance. 

“Management” as used in this volume refers to the processes for conduct and control of a 

radiation safety program and to the individuals who are responsible for those processes and 

who have authority to provide necessary resources to achieve regulatory compliance.

3.1 Commitments and Responsibilities

Pursuant to 10 CFR 30.32(c), each application shall be signed by the applicant or licensee or a 

person duly authorized to act for and on the behalf of the applicant or licensee. If it is not clear 

whether the application was signed by someone duly authorized to act for and on the behalf of 

the applicant or licensee, NRC license reviewers may ask for additional assurances that the 

individual that signed the application is duly authorized to act for and on the behalf of the 

applicant or licensee. The signature on an application acknowledges the licensee’s 

commitments and responsibilities for the following:

• Completeness and accuracy of records and all information provided to the NRC 

(10 CFR 30.9, “Completeness and accuracy of information”);

• Knowledge about the contents of the application;

• Applying for a registration certificate amendment if the information provided in the 

application or contained in the certificate is modified or changed; registration certificate 

holders must comply with the information in the registration certificate until the certificate 

is amended;

• Providing adequate resources (including space, equipment, personnel, time, and, if 

needed, contractors) to ensure that the registration certificate holder meets its regulatory 

requirements;

• The registration certificate holder is required to manufacture or distribute the product in 

accordance with the following:

– the statements and representations contained in the application for safety review 

and registration

– the provisions of the registration certificate; and

– NRC regulations.

For information on NRC inspection, investigation, enforcement, and other compliance programs, 

see the current version of the NRC’s Enforcement Policy and Inspection Procedures available in 

the NRC’s online library at http://www.nrc.gov/reading-rm.html.
8

3.2 Safety Culture

Individuals and organizations performing regulated activities are expected to establish and 

maintain a positive safety culture commensurate with the safety and security significance of 

their activities and the nature and complexity of their organizations and functions. This applies 

to all licensees, certificate holders, permit holders, authorization holders, holders of quality 

assurance program approvals, vendors and suppliers of safety-related components, and 

applicants for a license, certificate, permit, authorization, or quality assurance program approval, 

subject to NRC authority.

“Nuclear safety culture” is defined in the NRC’s safety culture policy statement (76 FR 34773; 

June 14, 2011) as the core values and behaviors resulting from a collective commitment by 

leaders and individuals to emphasize safety over competing goals to ensure protection of 

people and the environment. Individuals and organizations performing regulated activities bear 

the primary responsibility for safely handling and securing these materials. Experience has 

shown that certain personal and organizational traits are present in a positive safety culture. A 

trait, in this case, is a pattern of thinking, feeling, and behaving that emphasizes safety, 

particularly in goal conflict situations (e.g., production versus safety, schedule versus safety, 

and cost of the effort versus safety). Refer to Table 3.1 for the traits of a positive safety culture 

from NRC’s safety culture policy statement.

The NRC, as the regulatory agency with an independent oversight role, reviews the 

performance of individuals and organizations to determine compliance with requirements and 

commitments through its existing inspection and assessment processes. However, NRC’s 

safety culture policy statement and traits are not incorporated into the regulations. Many of the 

safety culture traits may be inherent to an organization’s existing radiation safety practices and 

programs. For instance, applications for sealed source and device registrations must include

details of the quality control program, as indicated in 10 CFR 32.210(f)(1), that will be 

implemented to ensure that the radiation safety properties of the source or device are adequate 

to protect health and minimize danger to life and property. The need to establish and maintain a 

quality control program may correspond with the safety culture traits specified in Table 3.1 as 

“Work Processes” (the process of planning and controlling work activities is implemented so that 

safety is maintained) and “Problem Identification and Resolution” (issues potentially impacting 

safety are promptly identified, fully evaluated, and promptly addressed and corrected 

commensurate with their significance).

Refer to Appendix I for the NRC’s safety culture policy statement. More information on NRC 

activities relating to safety culture can be found at: http://www.nrc.gov/aboutnrc/regulatory/enforcement/safety-culture.html.
9

Table 3.1 Traits of a Positive Safety Culture

Leadership Safety Values 

and Actions 

Problem Identification and 

Resolution Personal Accountability 

Leaders demonstrate a 

commitment to safety in their 

decisions and behaviors 

Issues potentially impacting 

safety are promptly 

identified, fully evaluated, 

and promptly addressed and 

corrected commensurate 

with their significance 

All individuals take personal 

responsibility for safety 

Work Processes Continuous Learning 

Environment for Raising 

Concerns 

The process of planning and 

controlling work activities is 

implemented so that safety 

is maintained 

Opportunities to learn about 

ways to ensure safety are 

sought out and implemented 

A safety conscious work 

environment is maintained 

where personnel feel free to 

raise safety concerns without 

fear of retaliation, 

intimidation, harassment or 

discrimination 

Effective Safety 

Communications 

Respectful Work 

Environment Questioning Attitude 

Communications maintain a 

focus on safety 

Trust and respect permeate 

the organization 

Individuals avoid 

complacency and continually 

challenge existing conditions 

and activities in order to 

identify discrepancies that 

might result in error or 

inappropriate action 

11

4. APPLICABLE REGULATIONS

It is the applicant, licensee, or registrant’s responsibility to obtain and have available up-to-date 

copies of applicable regulations, to read and understand the requirements of each of these 

regulations, and to comply with each applicable regulation. The following parts of Title 10 of the 

Code of Federal Regulations (10 CFR) contain regulations applicable to sealed source and 

device evaluations. These parts will apply to many, if not all, licensees.

The current versions of these parts can be found under the “Basic References” link at the NRC’s 

online library at http://www.nrc.gov/reading-rm.html; if viewing in a browser, the following list 

includes a direct link to the rules:

• 10 CFR Part 2, “Rules of Practice for Domestic Licensing Proceedings and Issuance of 

Orders”

• 10 CFR Part 19, “Notices, Instructions and Reports to Workers: Inspection and 

Investigations”

• 10 CFR Part 20, “Standards for Protection Against Radiation”

• 10 CFR Part 21, “Reporting of Defects and Noncompliance”

• 10 CFR Part 30, “Rules of General Applicability to Domestic Licensing of Byproduct 

Material”

• 10 CFR Part 31, “General Domestic Licenses for Byproduct Material”

• 10 CFR Part 32, “Specific Domestic Licenses to Manufacture or Transfer Certain Items 

Containing Byproduct Material”

• 10 CFR Part 34, “Licenses for Industrial Radiography and Radiation Safety 

Requirements for Industrial Radiographic Operations”

• 10 CFR Part 35, “Medical Use of Byproduct Material”

• 10 CFR Part 36, “Licenses and Radiation Safety Requirements for Irradiators”

• 10 CFR Part 37, “Physical Protection of Byproduct Material: Category 1 and 2

Quantities of Radioactive Material”

• 10 CFR Part 39, “Licenses and Radiation Safety Requirements for Well Logging”

• 10 CFR Part 40, “Domestic Licensing of Source Material”

• 10 CFR Part 70, “Domestic Licensing of Special Nuclear Material”

• 10 CFR Part 71, “Packaging and Transportation of Radioactive Material”

• 10 CFR Part 110, “Export and Import of Nuclear Equipment and Material”
12

• 10 CFR Part 170, “Fees for Facilities, Materials, Import and Export Licenses, and Other 

Regulatory Services Under the Atomic Energy Act of 1954, as Amended”

• 10 CFR Part 171, “Annual Fees for Reactor Licenses and Fuel Cycle Licenses and 

Materials Licenses, Including Holders of Certificates of Compliance, Registrations, and 

Quality Assurance Program Approvals and Government Agencies Licensed by the NRC”

Copies of the above documents may be obtained by calling the Government Printing Office 

order desk toll free at (866) 512-8600, or in Washington, DC, at (202) 512-1800, or online at 

http://bookstore.gpo.gov. 

A single copy of the above documents may be requested from the NRC’s regional offices (see 

Figure 2.1 for addresses and telephone numbers). In addition, 10 CFR Parts 1 through 199 can 

be found on the NRC’s Web site at http://www.nrc.gov/reading-rm/doc-collections/ under 

“Regulations (10 CFR).” 

NRC regulations and amendments can also be accessed from the “NRC Library” link on the 

NRC’s public Web site at http://www.nrc.gov. The NRC and all other Federal agencies publish 

amendments to their regulations in the Federal Register.

The regulations embodied in 10 CFR 30.32(g) and 10 CFR 32.210, “Registration of product 

information,” codify the current and longstanding practice whereby vendors of sealed sources of 

radioactive material and devices containing sealed sources submit the radiation safety 

information necessary to perform an independent, technical safety evaluation and to obtain 

registration of radiation safety information on certain sealed sources and devices. The specific 

provisions in 10 CFR 30.32(g) require a license applicant to either make reference to a 

registered sealed source or device or provide the information necessary to perform a safety 

evaluation of the sealed source or device. 10 CFR 32.210 outlines the NRC safety evaluation 

and registration criteria and clarifies the regulatory responsibility of registration certificate 

holders of products for which the NRC evaluates and registers radiation safety information.

A license applicant may submit an application to manufacture and/or distribute products to be 

used by specific licensees, general licensees, or an exempt or a custom user. Current 

regulations require that manufacturers and distributors register with the Commission most

products used under a specific or general license issued in accordance with 10 CFR Part 30 or 

10 CFR Part 31. However, if the NRC deems registration of a product design to be necessary, 

the applicant must provide the information called for in 10 CFR 32.210, and the NRC will 

evaluate the application in the same manner as all registration applications.

The products listed in Sections 4.1–4.6 of this chapter are used by persons exempt from 

licensing requirements or used in accordance with a general license, and the NRC has 

determined that registration of the product design is necessary. However, in addition to the 

general registration criteria in 10 CFR 32.210, the regulations require that the products meet 

certain specific requirements. These specific requirements are listed in the appropriate section 

(Sections 4.1–4.4.6) and need to be addressed during the product evaluation.

Some specifically licensed products are required, by regulation, to meet certain specific 

requirements in addition to the general registration criteria provided in 10 CFR 32.210. The 

specific requirements for these products are listed in Sections 4.7–4.10 and need to be 

addressed during the product evaluation.
13

A sealed source or device that contains naturally occurring or accelerator-produced radioactive 

material (NORM or NARM) is under the regulatory jurisdiction of the NRC. The NRC maintains 

the NSSDR that includes information about such materials; the applications for registration and 

amendments for sealed sources or devices containing NORM/NARM sources must be filed with 

the NRC. The NRC will place a copy of the source and design registrations in the NSSDR.

4.1 Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 

for Use by Persons Exempt from Licensing Requirements

Under 10 CFR 30.19, “Self-luminous products containing tritium, krypton-85, or 

promethium-147,” persons are exempted from licensing requirements if the products are initially 

transferred in accordance with a license issued under 10 CFR 32.22, “Self-luminous products 

containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, 

process, produce, or initially transfer.” Therefore, the requirements for product evaluation are 

imposed on the person licensed to manufacture or initially transfer the product. Specific 

requirements, imposed on the product design, that must be addressed during the product 

evaluation are listed below:

Area To Be Addressed Applicable 

10 CFR Regulations

Design 30.19(a) & (c), 32.22(a)

Maximum Radiation Levels 32.22(a)(2)(vi)

Maximum Dose Commitments 32.22(a)(2)(xiii) & (xiv)

Labeling

Registration

32.25(b)

30.19(b)

The registration certificate should list all models of each type of product that are distributed. 

Some models may be designed and fabricated as a series. In order to have the model listed as 

a series, there should be similarities in the design and construction of the devices. Applicants 

should provide detailed engineering drawings of each basic device series containing the overall 

dimensions; the minimum and maximum dimensions for each series type; the tolerances, 

description, or identification of the construction materials; and the source mounting 

configuration(s) to be used with each series type. This information should be provided for each 

type of material used, such as steel, aluminum, or plastic. The application should include a list 

of the differences between the models in that series.

NUREG-1556, Volume 8, “Consolidated Guidance about Materials Licenses: Program-Specific 

Guidance about Exempt Distribution Licenses,” contains the design and prototype testing 

requirements for gunsights. Acceptable procedures that test for leaking tritium vial sources may 

include swipe testing as well as brightness, light output, or immersion testing based on the rates 

of tritium leakage over a specific time period. Further guidance on exempt distribution licenses 

can be found in NUREG 1556, Volume 8.

The regulations in 10 CFR 32.25(b) require that each unit is marked or labeled so that the 

person licensed under 10 CFR 32.22 can be identified. Identification can be the full name of the 

licensee, its registered trademark, or its exempt distribution license number.
14

The use of tritium, krypton-85, and promethium-147 in toys, novelties, adornments, or similar 

consumer products is considered a frivolous use of radioactive material. The regulations do not

allow issuing registration certificates for such applications or for applications in which the end 

use of the product cannot be reasonably foreseen (10 CFR 30.19(c) and 10 CFR 32.22(b)). 

Although foreign countries may permit the devices to be commercially distributed, such devices

cannot be distributed in the United States as delineated, in the NRC Consumer Products Policy 

Statement (30 FR 3462; March 16, 1965). 

Figure 4.1 Watches and Aiming Sights. Watches and aiming sights are products 

distributed to persons exempt from licensing under 10 CFR 30.19.
15

 

Figure 4.2 Smoke and Chemical Agent Detectors. Smoke and chemical agent 

detectors are products distributed to persons exempt from licensing under 

10 CFR 30.20, “Gas and aerosol detectors containing byproduct material.”

4.2 Gas and Aerosol Detectors Containing Byproduct Material for Use by Persons 

Exempt from Licensing Requirements

Under 10 CFR 30.20, persons are exempted from licensing requirements if the products are 

initially transferred in accordance with a license issued under to 10 CFR 32.26, “Gas and 

aerosol detectors containing byproduct material: Requirements for license to manufacture, 

process, produce, or initially transfer.” Therefore, the requirements for product evaluation are 

imposed on the person to be licensed to manufacture or initially transfer the product. Specific 

requirements, imposed on the product design, that must be addressed during the product 

evaluation are listed below:

Area To Be Addressed Applicable 10 CFR Regulations

Design 30.20(a), 32.263

Maximum Radiation Levels 32.26(b)(6)

Maximum Dose Commitments 32.26(b)(13) & (14)

Labeling 32.29(b)4

Registration 30.20(b)

Further guidance on exempt distribution licenses can be found in NUREG 1556, Volume 8.

 3

 This regulation is applicable to applications to manufacture, process, or product devices designed to protect

 health, safety, or property or to initially transfer such products for use under 10 CFR 30.20. It has been 

 determined that gas and aerosol detectors designed to detect explosives or chemical agents may be licensed for

 distribution in accordance with this regulation. 4

 The regulation requires identification of the person licensed under 10 CFR 32.26. Identification can be the full

 name of the licensee, its registered trademark, or its NRC exempt distribution license number.
16

4.3 Industrial Devices for Use by Persons Exempt from Licensing Requirements

Certain industrial devices are exempt from licensing requirements by the user under 10 CFR 

30.22(a) . These are industrial devices designed and manufactured for the purpose of detecting, 

measuring, gauging, or controlling thickness, density, level, interface location, radiation, 

leakage, or qualitatitive or quantitative chemical composition or for producing and ionized 

atmosphere. However, manufacturers and distributors of these products need to apply for a 

license and a sealed source and device registration under 10 CFR 32.30.

Further guidance on exempt distribution licenses can be found in NUREG 1556, Volume 8.

4.4 Devices Used under the General License in 10 CFR 31.5

Under 10 CFR 31.5, “Certain detecting, measuring, gauging, or controlling devices and certain 

devices for producing light or an ionized atmosphere,” persons may use certain devices in 

accordance with a general license so long as the devices were manufactured or initially 

transferred in accordance with a license issued pursuant to 10 CFR 32.51, “Byproduct material 

contained in devices for use under § 31.5; requirements for license to manufacture or initially 

transfer,” and 10 CFR 32.51a, “Same: Conditions of license.” The devices used under the 

general license include devices designed for the purpose of producing light or an ionized 

atmosphere or for detecting, measuring, gauging or controlling thickness, density, level, 

interface location, radiation, leakage, or qualitative or quantitative chemical composition. The 

requirements for product evaluation are imposed on the person to be licensed to manufacture or 

initially transfer the product. Further guidance on general licenses can be found in NUREG 

1556, Volume 16, “Consolidated Guidance about Materials Licenses: Program-Specific 

Guidance about Licensees Authorizing Distribution to General Licensees.” Specific 

requirements, imposed on the product design that must be addressed during the product 

evaluation are listed below:

Area To Be Addressed Applicable 10 CFR Regulations

Design 31.5(a), 32.51(a)(2)(i)

Maximum Dose Commitments 32.51(a)(2)(ii) & (iii)

Labeling 32.51(a)(3)

Leak Testing 32.51(b)

Testing and Servicing 32.51(b) & (c)

Installation, Use, and Removal 32.51 (c)

Device Registration 32.51(a)(6)
17

 Figure 4.3 10 CFR 31.5 General License. Density gauges and gas chromatograph

devices are products used under 10 CFR 31.5 general license. 

For generally licensed products containing certain byproduct materials in quantities of concern, 

the reviewer must be aware that the NRC or Agreement State security requirements are also 

applicable. The reviewer should include a Reviewer’s Note in the device registration regarding 

the security requirements and should also coordinate the issuance of the registration certificate 

with the NRC or Agreement State licensing staff. 

The security requirements apply to the use and transport of International Atomic Energy Agency 

(IAEA) Category 2 and above quantities of radioactive material, which the NRC considers to be 

risk-significant and, therefore, warrant additional protection. Category 2 and above thresholds 

are based on quantity thresholds established in the IAEA Code of Conduct on the Safety and 

Security of Radioactive Sources. The NRC’s security requirements for byproduct material in 

quantities of concern are in 10 CFR Part 37, “Physical Protection of Category 1 and Category 2 

Quantities of Radioactive Material.”

To determine whether the Part 37 requirements are applicable, see the threshold quantities 

listed in 10 CFR Part 37, Appendix A. The sum of fractions method must be used to evaluate 

combinations of multiple sources or multiple radionuclides. Refer to the footnote to Part 37 

Appendix A, Table 1, “Calculations Concerning Multiple Sources or Multiple Radionuclides,” for 

a description of the sum of fractions method and instructions for applying this method. 

 

4.5 Luminous Safety Devices Used in Aircraft under 10 CFR 31.7

Under 10 CFR 31.7, “Luminous safety devices for use in aircraft,” persons may use luminous 

safety devices containing not more than 10 curies (Ci) of tritium or not more than 300 millicuries 

(mCi) of promethium-147, in accordance with a general license so long as the devices were 

manufactured or initially transferred in accordance with a license issued pursuant to 

10 CFR 32.53,, “Luminous safety devices for use in aircraft: Requirements for license to 

manufacture, assemble, repair or initially transfer.” Therefore, the requirements for product 

evaluation are imposed on the person to be licensed to manufacture or initially transfer the 

product. Specific requirements, imposed on the product design that must be addressed during 

the product evaluation, are listed below:
18

Area To Be Addressed Applicable 10 CFR Regulations

Design 32.53(c) & (d)

Prototype Testing5 32.53(d)(4)

Units Required for Prototype Testing

Labeling

32.53(e)

32.54

Quality Control 32.55

Registration 32.53(f)

 Figure 4.4 10 CFR 31.7 General License. Safety devices, such as exit signs, 

containing tritium or promethium-147 and used in aircraft may be used 

under a 10 CFR 31.7 general license.

4.6 Ice Detection Devices Containing Strontium-90

Under 10 CFR 31.10, “General license for strontium-90 in ice detection devices,” persons may 

use ice detection devices containing strontium-90 in accordance with a general license so long 

as the devices were manufactured or initially transferred in accordance with a license issued 

pursuant to 10 CFR 32.61, “Ice detection devices containing strontium-90; requirements for 

license to manufacture or initially transfer.” Therefore, the requirements for product evaluation 

are imposed on the person licensed to transfer the product. Specific requirements, imposed on 

the product design that must be addressed during the product evaluation are listed below:

Area To Be Addressed Applicable 10 CFR Regulations

Design 32.61(c) & (e)

Labeling 32.61(d)

Prototype Testing6 32.61(e)(4)

Quality Control

Registration

32.61(e)(5), 32.62

32.61(g)

 5

 See NUREG 1556, Volume 16, “Program-Specific Guidance About Licenses Authorizing Distribution to General

 Licensees,” for guidance on prototype testing for generally licensed devices under 10 CFR 31.7 or

 10 CFR 31.10. 6 See NUREG 1556, Volume 16, “Program-Specific Guidance About Licenses Authorizing Distribution to

 General Licensees,” for guidance on prototype testing for generally licensed devices under 10 CFR 31.7 or

 10 CFR 31.10.
19

4.7 Radiography Equipment

Persons specifically licensed to perform industrial radiographic operations are only authorized to 

use equipment that meets the requirements of 10 CFR Part 34. The vendor or custom user of 

the equipment may demonstrate that the equipment meets these requirements as part of the 

evaluation and registration of the equipment. Therefore, during an evaluation of radiography 

equipment, the items listed below must be addressed:

Area To Be Addressed Applicable 10 CFR Regulations

Design 34.20(a), 34.22

Source Assemblies 34.20(b)(3)

Transport Containers 34.20(b)(2)

Associated Equipment 34.20(b)(2), 34.20(c)

Leak Testing 34.27

Labeling 34.20

Prototype Testing 34.20

Maximum Radiation Levels 34.20, 34.21

Figure 4.5 Radiography Equipment. Radiography equipment, such as the 

equipment shown above, must meet the requirements of 10 CFR Part 34.
20

NUREG-1556, Volume 2, “Program-Specific Guidance about Industrial Radiography Licenses,” 

provides guidance to an applicant preparing an industrial radiography license application. This 

guidance also identifies the requirements for the maintenance and inspection of radiography 

cameras and associated equipment.

There is no requirement to identify associated equipment in an SSD certificate Only as a

matter of convenience, an SSD applicant may include on the certificate the description of

associated equipment that is compatible with the radiographic source or device. The NRC has

discontinued the practice of registering associated equipment because the agency determined

that the Commission’s regulations do not require the registration of associated equipment (see

notice published in the Federal Register, 68 FR 41757; July 15, 2003). The regulations

(10 CFR 34.20, “Performance requirements for industrial radiography equipment”) require a

licensee to use industrial radiography equipment that has been manufactured and tested to

meet radiation safety design and performance criteria in accordance with a national consensus

standard (American National Standards Institute (ANSI) N43.9, successor to ANSI N432-1980

which is referenced in 10 CFR 34.20, "Gamma Radiography – Specifications for Design and

Testing of Apparatus" ). The life cycle test in the standard is an evaluation of the endurance of

a source or device. To test the life cycle of an industrial radiography source or exposure device,

all components of the industrial radiography system (including the associated equipment) must

be assembled and operated for the duration of the test. This requirement is sufficient to

maintain safety.

4.8 Well-Logging Equipment

Persons specifically licensed to perform well-logging operations are only authorized to use 

equipment that meets the requirements of Subpart C, “Equipment,” of 10 CFR Part 39, 

“Licenses and Radiation Safety Requirements for Well Logging.” For well-logging equipment, 

only the sealed sources are evaluated and registered, not the logging devices (i.e., logging 

sources or source holders (bullnoses)). One requirement is that the licensed material be as 

insoluble and non-dispersible as practicable. The vendor or custom user of the equipment may 

demonstrate that the equipment meets the requirements as part of the evaluation and 

registration of the equipment. Further guidance can be found in NUREG 1556 Vol. 14, “

Program-Specific Guidance about Well Logging, Tracer, and Field Flood Study Licensees.” 

During an evaluation of well-logging equipment, the items listed below must be addressed:

Area To Be Addressed Applicable 10 CFR Regulations

Labeling 39.31(a)

Leak Testing 39.35

Design 39.41(a)(1) & (2)

Prototype Testing 39.41(a)(3)
21

Figure 4.6 Well-Logging Operations. Sealed sources used in well-logging 

operations must meet the requirements of 10 CFR Part 39.

4.9 Irradiators

Irradiators are classified into four different categories. These categories are Category I (self 

contained dry source storage), Category II (Panoramic dry source storage), Category III (wet 

source self contained irradiator), and Category IV (wet source storage panoramic irradiator). 

See the standards referenced in Appendix F.

There are special requirements for the use of sealed sources in wet irradiators (ANSI Category 

III and IV). These sources must meet the requirements of 10 CFR 36.21, “Performance criteria 

for sealed sources” in addition to those in 10 CFR 32.210. One such requirement is that the 

licensed material be as insoluble and non-dispersible as practical if used in a wet-sourcestorage or wet-source-change irradiator. The vendor or custom user of the sealed sources may 

demonstrate that the sealed sources meet the requirements as part of the evaluation and 

registration of the sealed source. Therefore, during an evaluation of irradiator sources, the 

items listed below must be addressed:

Area To Be Addressed Applicable 10 CFR Regulations

Design 36.21(a)(2), (3), & (4)

Leak Testing 36.59

Prototype Testing 36.21(a)(5)

 
22

Figure 4.7 Irradiators. The NRC evaluates (1) Category I (self-shielded) irradiators 

both the source and the device and (2) sealed sources used in category II, 

III, and IV irradiators.

4.10 Sealed Sources and Devices for Medical Use

Regarding licensing, 10 CFR 35.49, “Suppliers for sealed sources or devices for medical use,” 

provides that only sealed sources and devices that are manufactured, labeled, packaged, and 

distributed in accordance with a license issued under 10 CFR Part 30 and 10 CFR 32.74, 

“Manufacture and distribution of sources or devices containing byproduct material for medical 

use,” may be used for medical purposes. Regarding performance requirements for sources 

used in medical applications, the provisions of 10 CFR 32.210 also apply. Calibration, 

transmission, and reference sources in 10 CFR 35.65(a) and 35.65(b) used by medical 

licensees must also meet the requirements in 10 CFR 32.74. Further guidance can be found in

NUREG-1556, Volume 9, Program-Specific Guidance about Medical Use Licenses.” During an 

evaluation of sources for medical uses, the items listed below must be addressed:

Area To Be Addressed Applicable 10 CFR Regulations

Labeling 32.74(a)(2)(viii) & (a)(3)

Leak Testing

Registration

32.74(b)

32.74(a)(4)

Teletheraphy sources are an exception to the above requirement. Specifically, teletherapy 

sources do not need to meet the requirements of 10 CFR 32.74. However, 10 CFR 35.49(c) 

indicates that these sources do need to be manufactured and distributed in accordance with a 

license issued pursuant to 10 CFR Part 30.

Before evaluation of a sealed source or device for medical use, the applicant must provide proof 

of U.S. Food and Drug Administration (FDA) approval. Sealed sources are evaluated either as 

part of the medical device or separately when they can be interchanged in several devices. 

FDA uses the term “device” for both sealed sources and devices.
23

The NRC will not issue a sealed source and device registration without one of the following four 

FDA approvals :

(1) Premarket Notification (510(k))

A 510(k) notification is a premarketing submission made to FDA to demonstrate that the 

device to be marketed is safe and effective and is substantially equivalent to other 

devices currently marketed.

(2) Premarket Approval (PMA)

A PMA is the FDA process of scientific and regulatory review to evaluate the safety and 

effectiveness of Class III7 medical devices. Class III devices are those that support or 

sustain human life, are of substantial importance in preventing the impairment of human 

health, or present a potential, unreasonable risk of illness or injury.

(3) Humanitarian Device Exemption (HDE)

An HDE application is similar in both form and content to a PMA application, but a 

humanitarian use device is exempt from the effectiveness requirements of a PMA. A

humanitarian use device is a device that is intended to benefit patients by treating or 

diagnosing a disease or condition that affects fewer than 4,000 individuals in the 

United States per year.

(4) Investigational Device Exemption (IDE)

An IDE allows the investigational device to be used in order to collect the safety and 

effectiveness data required to support a PMA application or a 510(k) submission to FDA. 

Either an Institutional Review Board (IRB) alone or both an IRB and FDA can approve 

an IDE.

Manufacturers are not required to have IDE devices reviewed for inclusion in the 

NSSDR. If an IDE device is not registered, only broad scope licensees having an IRB 

may participate in the clinical trials of the device, and they are required to perform their 

own safety analysis.

As part of the application, applicants should provide the following proof that FDA reviewed the 

information:

• type of FDA approval (510(k), IDE, PMA, HDE, or IDE)

• sealed source activity for patient treatment approved by FDA (if applicable)

• any specific conditions or limitations imposed by FDA that users should know

 7 The FDA classifies medical devices under its regulations in 21 CFR into three classes, Class I, Class II, and 

Class III. The device classification will determine the controls and regulations that apply to each class. Device 

classification depends on the intended use of the device and indications of use.
24

Proof may consist of a copy of the information provided to FDA for review, or a document with 

the information issued by FDA. The SSD application includes these references for information 

only, and the NRC and Agreement States do not review them.

Class I medical devices (e.g. dose calibration sources, radioactive rulers and markers, nuclear 

flood source phantoms, as listed in 21 CFR 892) do not require a distributor to obtain premarket 

clearance from FDA prior to marketing. Such Class I devices are exempt from the 510(k) 

premarket approval under 21 CFR 807 Subpart E. Therefore, device registrations can be 

issued in such cases without the FDA premarket approvals listed above. It must be noted that 

at times, the distributor does submit a 510(k) submission for Class I devices to the FDA. There 

may be reasons other than meeting regulations, e.g. the distributor may wish to be able to state 

that itsdevice has a 510(k) clearance for purely marketing reasons. In that case if the distributor 

submits a 510(k) request to FDA, FDA will review the device even though the regulations do not 

require it. Master Materials Licensees may not perform their own SSD review. A broad scope 

permitee under a master materials license may perform its own safety analysis for sealed 

sources and devices as allowed under 10 CFR 33.13(c)(3)(iii).

Section 5.1.2, “Products Used in Research and Development or by Broad Scope Licensees,” of 

this document contains additional information on broad scope licenses.
25

5. GENERAL POLICIES AND PROCEDURES

5.1 Sealed Source and Device Designs that Do Not Require Evaluation and 

Registration

The provisions of 10 CFR 30.32(g) apply to all sealed sources and devices to be used by NRC 

specific licensees. Sealed sources and devices are required to be registered under 

10 CFR 32.210. Exceptions to this are given in 10 CFR 32.210(g). Also, the possession and 

use of certain products do not require NRC or Agreement State evaluation and registration of 

the product. This section describes when sources and devices are not required to be 

registered. In these cases, an alternative evaluation of the safety of the product is made in 

evaluating the license application.

5.1.1 Calibration and Reference Sources

Calibration and reference sources may be licensed without registration by the NRC or 

Agreement States if the sources do not exceed the following, as specified in 10 CFR 

32.210(g)(1):

• For beta and/or gamma emitting material—37 (MBq) (1 mCi)

• For alpha emitting material—0.37 MBq (10 microcuries (μCi))

To license these sources, license reviewers need to identify the isotope in Item 6 of the NRC 

materials license (NRC Form 374), use the statement “calibration or reference sources” in Item 

7, and state the maximum quantity for each source in Item 8. Both the possession and 

distribution of the product to specific licensees may be authorized.

Note that energy compensation sources, when used in the well-logging industry, must meet the 

requirements of 10 CFR 32.210 (see the provisions of 10 CFR 39.41(f)) even if they have an 

activity level of less than 37 MBq (1 mCi).

Sources that are below the activity limits but are designed to be used for medical diagnosis will 

need a safety evaluation. In accordance with 10 CFR 35.500, “Use of sealed sources for 

diagnosis,” which requires that only those sealed sources which are approved in the Sealed 

Source and Device registry shall be used for diagnostic purposes.

Calibration and reference sources to be used under the general license in 10 CFR 31.8, 

“Americium-241 and radium-226 in the form of calibration or reference sources,” are not 

required to be registered. 

Some of the byproduct material distributed for use under the exemption in 10 CFR 30.18, 

“Exempt quantities,” is also in calibration and reference sources. The manufacture and 

commercial distribution of these sources are licensed under 10 CFR 32.18, “Manufacture, 

distribution and transfer of exempt quantities of byproduct material: Requirements for license.” 

These sources are also not required to be registered.

The NRC does not authorize combining, also referred to as “bundling,” exempt quantity sources 

in products for commercial distribution under 10 CFR 30.18(e). NRC Generic Letter 99-01,

“Recent Nuclear Material Safety and Safeguards Decision on Bundling Exempt Quantities,” 

dated May 3, 1999, gives the NRC’s position on bundling. In some specific applications, the 
26

use of multiple calibration sources is permitted as specified by the provisions of 

10 CFR 30.15(a)(9). This use is limited to ionizing radiation instruments with internal calibration 

or standardization sources. To manufacture and distribute a device with multiple internal

calibration sources, the applicant must satisfy the applicable requirements for licensing 

(10 CFR 32.14, “Certain items containing byproduct material; requirements for license to apply 

or initially transfer”).

Figure 5.1 Calibration and Reference Sources. Calibration and reference sources 

may not need a registration by the NRC or Agreement States.

5.1.2 Products Used in Research and Development or by Broad Scope Licensees

Sealed sources or devices containing sealed sources that are intended only for use under 

research and development or broad-scope licenses need not be registered by the NRC or the 

Agreement State if the following is valid:

• For unregistered sources, or registered sealed sources not possessed and used in 

accordance with the registration, the licensee is qualified by sufficient training and 

experience and has sufficient facilities and equipment to safely use and handle the 

requested quantity of radioactive material.

• For registered sealed sources contained in unregistered devices, the licensee is 

qualified by sufficient training and experience and has sufficient facilities and equipment 

to safely use and handle the requested quantity of radioactive material in unshielded 

form. 

The NRC has granted broad-scope licensees the authority to use sealed sources and/or 

devices that have been fabricated by or obtained from licensed vendors without prior NRC or 

Agreement State review and registration. However, broad-scope licensees also have the 

responsibility for appropriately evaluating the sealed source or device and conducting activities 

responsibly and safely. For example, for Type A specific licensees of broad scope, 

10 CFR 33.13(c)(3)(iii) requires the radiation safety committee to review and approve these 

safety evaluations. This is especially important with the advent of emerging medical 

technologies used under 10 CFR Part 35. FDA reviews for medical efficacy of a product cannot 

be substituted for this evaluation. The review should determine whether a source or device can 

be used safely from a radiological standpoint and whether adequate radiological protection can 

be provided for its intended use at the institution. This review should be commensurate with the 
27

level of risk that could be reasonably anticipated from the source or device for its intended use 

and likely accident conditions. The licensee is responsible for performing this review, obtaining

any necessary design and test information from the vendor, and, if needed, conducting

operational tests or other tests to discover and evaluate potential radiation safety hazards.

If a research and development or broad-scope licensee wishes to transfer a sealed source or 

device to another specific licensee, then the recipient must meet the criteria listed above, or the 

sealed source or device must be registered in accordance with 10 CFR 32.210 prior to transfer.

5.1.3 Custom Sealed Sources or Devices

Sealed sources or devices containing sealed sources built to the unique specifications of a 

given user (i.e., custom sealed sources or devices) need not be sent to the NRC or the 

Agreement State for registration if (1) they contain less than 7.4 gigabecquerels (GBq) (200

mCi) of radioactive material or less than 740 GBq (20 Ci) of tritium, and (2) the licensing 

reviewer has made a determination that the applicant is qualified by training and experience and 

has adequate facilities and equipment to safely use and handle the requested quantity of 

radioactive material in unsealed form, refer to 10 CFR 32.210(g)(2). Thus, the applicant would 

not have to rely on the intrinsic safety of the sealed source or device to demonstrate compliance 

with 10 CFR 30.33, “General requirements for issuance of specific licenses.” Custom sealed 

sources and devices that contain an activity greater than that listed above must be submitted to

the NRC or the Agreement State for evaluation and registration.

To license these custom sealed sources and/or devices, license reviewers need to identify the 

isotope in Item 6 of the material license (NRC Form 374); use the statement “custom source” 

(for unregistered sources) or “sealed source” (for registered sealed sources), including a unique 

identifier (e.g., drawing or model number), if possible, in Item 7; and state the maximum quantity 

of radionuclide per source or device in Item 8. In Item 9 (authorized use), license reviewers 

need to describe, as clearly as possible, the actual use of the custom source or device (e.g., “for 

use in a Model A analyzer custom built for the licensee by ABC Company in Anytown” or 

“custom source for use in XYZ Model 100 gauge”).

The authorization to use sources or devices of the types described above (that have not been 

evaluated and registered by the NRC or the Agreement State) applies only to the custom user 

of the product. Licensees with custom sealed sources and devices should inactivate the custom 

registration in accordance with Section 13.4, “Transfers to Inactive Status,” of this guide when 

the sources or devices are permanently disposed of, placed in permanent storage, or 

transferred to another licensee that has obtained its own custom registration or that has broad

scope authorization.

Because custom evaluations encompass specific safety features and operating procedures for 

each location of use, a new custom evaluation must be performed when devices are transferred 

to new locations.
28

5.1.4 Items Containing Byproduct Material Listed in 10 CFR 30.15 

Under 10 CFR 30.15, “Certain items containing byproduct material,” persons are exempted from 

licensing requirements for the possession, use, transfer, or ownership of certain specified

products. These products must be initially transferred in accordance with a specific license

issued pursuant to 10 CFR 32.14. Products containing radioactive material to be used under 

the exemption in 10 CFR 30.15 are not required to undergo a sealed source and device safety 

evaluation. Devices qualifying for a product-specific exemption may be distributed without a 

sealed source and device certificate. 10 CFR 30.15 lists the items for which registration is 

optional, such as timepieces, marine compasses, electron tubes, and ionization chamber smoke 

detectors containing not more than 1 μCi of americium (Am)-241 per detector in the form of a 

foil.

5.2 Custom Users

A “custom user” is a user of a product that is manufactured in accordance with the unique 

specifications of, and for use by, a single applicant. Custom users are specifically identified on 

the first page of registration certificates. Either the custom user or the vendor may make the

request for the safety evaluation and registration of the product. Regardless of the applicant, 

the custom registration is made to unique specifications, therefore, the custom user must meet 

all commitments made in the application and registration certificate. In some cases, a limited 

number of different NRC or Agreement State licensees may be custom users of, and may 

register, the same product. However, a custom user may acquire and/or use more than one 

product.

5.3 As Low As Is Reasonably Achievable

The NRC’s requirements to establish programs, procedures, and engineering controls for 

achieving doses that are as low as is reasonably achievable (ALARA) are in 10 CFR 20.1101, 

“Radiation protection programs.” Regulatory Guide 8.10, “Operating Philosophy for Maintaining 

Occupational Radiation Exposures as Low as Is Reasonably Achievable,” explains the NRC’s 

position on this subject. Although these requirements apply to possession and use of 

radioactive material, applicants should consider the ALARA philosophy when designing and 

constructing sealed sources or devices to avoid unnecessary exposures during installation, 

maintenance, repair, and use of the sealed source or device. Regulatory Guide 8.10 may be 

useful to applicants for establishing and following an ALARA philosophy during the design of a 

sealed source or device.

5.4 Naturally Occurring or Accelerator-Produced Radioactive Material

The NRC has jurisdiction over discrete sources of Ra-226, accelerator-produced radioactive 

materials, and other discrete sources of naturally occurring radioactive material, as required by 

the Energy Policy Act (EPAct) of 2005. Before enactment of the EPAct, certain States, 

including non-Agreement States, issued registrations for some sealed sources and devices 

containing Ra-226 or NARM. These registration certificates of sealed sources and devices 

were transitioned from State jurisdiction to NRC jurisdiction. 

The NRC should receive all applications for radiation safety evaluation and registration of 

sealed sources or devices that contain NARM. In accordance with the EPAct, the NRC 

amended the definition of byproduct material under NRC regulations in 10 CFR 30.4, 
29

“Definitions,” to include Ra-226 sources and NARM. The NRC will perform a review of these 

sealed sources and devices containing these byproduct materials and will issue certificates to 

manufacturers and distributors in NRC States and certain Agreement States who have not 

taken over the responsibility for evaluation and registration of sealed sources and devices. 

Questions concerning certificates for sealed sources containing NARM should be directed to the 

Director of MSSA/FSME.

5.5 Foreign Vendors

Foreign vendors present a unique situation in that the NRC has no jurisdiction over foreign 

entities. The provisions of 10 CFR 110.53(a) require a foreign vendor to establish an address in 

the United States to which the NRC can correspond and serve papers as necessary to 

accomplish its mission. Accordingly, the NRC accepts applications with a U.S. address from a 

foreign vendor and issues the registration certificate to the U.S. representative of the foreign 

vendor. The registration certificate designates the U.S. representative as the distributor of the 

product and lists the foreign vendor as the manufacturer. Section 10.1, “Summary Information,”

of this report provides further information on these designations. The U.S. distributor’s 

responsibilities include the implementation of a quality assurance (QA) program to ensure that 

the imported products are in accordance with the statements made in support of the registration 

certificates. In addition, the NRC inspects the distributor of the product and may periodically 

audit foreign vendors to determine if the products distributed in the United States are in 

accordance with the statements made in support of the registration certificates.

5.6 Use of International or Foreign Standards

In some cases, an applicant may wish to test a product in accordance with an international or 

foreign standard. In order for the NRC to find this acceptable, the applicant should first 

demonstrate and the reviewer must confirm that the standard meets or exceeds any specific 

regulatory requirements (e.g., compliance with ANSI N432-1980 for radiography equipment). 

To determine if the international or foreign standard is acceptable, the applicant and reviewer 

should each review the requirements and acceptance criteria of the standard based on the 

normal and likely accident conditions associated with the use, handling, storage, and transport 

of the product. The foreign or international standard may be compared with an applicable 

U.S. standard to determine the acceptability of the standard. The applicant and reviewer may 

need to exercise professional judgment to make this determination.

If a foreign standard is used, the applicant should submit copies of both the original and English 

translation of the standard with the application.
30

5.7 Medical Application—U.S. Food and Drug Administration–NRC Memorandum 

of Understanding

FDA and the NRC signed a Memorandum of Understanding (MOU)8 to coordinate existing FDA 

and NRC regulatory programs for medical devices, drugs, and biological products that make 

use of byproduct, source, or special nuclear materials. The principal statute under which FDA 

regulates devices is the Federal Food and Drug and Cosmetic Act, as amended by the Safe 

Medical Devices Amendments of 1976, the Safe Medical Devices Act of 1990, and the Medical 

Devices Act of 1992.

Under the MOU, the agencies agree to promptly inform each other whenever they receive a 

report or otherwise become aware of any potential public health problems involving products of 

mutual regulatory concern. Further, the agencies will share information to the extent 

practicable. For the NRC, this includes information used for product evaluations and approvals, 

and information related to any incidents involving product failures. The NRC should notify FDA

in writing when the NRC begins an evaluation of a medical product, whether it is for a new 

product or for an amendment to an existing product. The notification should include the 

company, product model number, and the scope of the request. NRC policy precludes the 

approval of a medical sealed source or device unless the applicant has submitted a copy of the 

PMA issued by FDA (FDA Form 510(k)). If the application does not include the PMA, the 

applicant will be instructed to contact the FDA and obtain the appropriate approval.

Applicants needing information on FDA requirements may contact FDA at the following address:

Food and Drug Administration

Center for Devices and Radiological Health

10903 New Hampshire Avenue

WO66-4613

Silver Spring, MD 20993 

Tel: 800-638-2041 or 301-796-5500

5.8 Computer Software

NRC safety evaluations concentrate only on those systems that control fundamental safety 

processes, such as checking an interlock, source, or shielding position and the functionality of 

position indicators. Software applications that deal with process controls are not part of the 

product evaluation. The coding of the software is not reviewed independently but the safety 

function of the software system is demonstrated by the prototype tests conducted for normal 

use and likely accident conditions (see Section 10.5, “Prototype Testing”). The reviewer will 

determine whether, if such systems fail (e.g., a power failure), the sealed source or shielding 

would return to, or remain in, the fully shielded position. 

 8

 The MOU was published in the Federal Register on December 23, 2002 (62 FR 15740).
31

5.9 Registration Certificate Revocation

Registration certificates maybe revoked if (1) the source or device is found to be unsafe for use, 

(2) the licensee fails to provide the required registration fees, (3) the licensee is out of business, 

or (4) the applicant provided false statements.

If it is determined that a sealed source or device evaluated by the issuing agency (NRC or the 

Agreement State) may pose an undue hazard when used in accordance with the conditions of 

the registration certificate, and corrective actions cannot be implemented or agreed upon 

between the registration certificate holder and the issuing agency, then the issuing agency may 

modify or remove the registration certificate from the NSSDR and may issue orders modifying 

licenses to all persons licensed to use the sealed source or device. The NRC shall remove the

active registration certificate from the NSSDR and replace it with an inactive registration 

certificate. NRC staff will notify the Agreement States to make them aware of the NRC actions 

concerning the sealed source or device.

5.10 Incidents and Defects

The NRC assesses incidents and defects involving products evaluated and registered by the 

agency to determine whether the integrity or adequacy of the product was compromised. The 

assessment involves a reevaluation of the product to determine its integrity and adequacy, 

taking into account the causes of the incident or defect. If the NRC determines that a generic 

product fault exists, it will notify the registration certificate holder and take appropriate actions, 

affecting both products currently in use and newly manufactured products. In addition, the NRC 

will reevaluate similar products to ensure that they are not susceptible to the same type of 

faults.

Usually, incidents caused by abnormal or unauthorized use of the product would be considered 

licensing issues and would not require a reevaluation of the product.

The NRC keeps on file certain information concerning incidents involving products evaluated by 

the agency for use in performing future evaluations of the products involved and products 

similar to those involved. The Office of Nuclear Security and Incident Response is the NRC 

office responsible for receiving, compiling, and distributing incident reports to the appropriate 

NRC Office.

Regarding failures to comply with the terms of the registration certificates or the existence of a 

defect, the provisions of 10 CFR 21.21, ““Notification of failure to comply or existence of a defect 

and its evaluation,” apply. Specifically, failures and defects must be must be reported to the 

NRC or if required, to the Agreement State (not all Agreement States have this requirement). 

The NRC staff will conduct a safety evaluation of the failure or defect similarly to the process 

describe above for incidents. 

Furthermore, the NRC has established a database to collect information on incidents, failures, 

and defects involving radioactive materials. This database is the Nuclear Material Events 

Database (NMED). FSME is the responsible office for adding the data to NMED.
32

5.11 Proprietary Information

The NRC may make available to the public, registration certificates and information, such as 

applications, contained in the background files for the registration certificates. Persons may 

request access to this information in accordance with 10 CFR 9.23, “Requests for records.”

An application should not include proprietary information (i.e., information not to be disclosed to 

the public) unless it is the only means to adequately describe the radiation safety properties of 

the product. If an application contains information marked as “proprietary,” “confidential,” 

“restricted,” or “is the express property of Company X,” the reviewer needs to determine 

whether the information is necessary to perform the safety evaluation. If the information is not 

necessary, it should be returned to the applicant.

If the information is necessary, the reviewer needs to ensure that the applicant has submitted a 

formal request for withholding the information, in accordance with 10 CFR 2.390, “Public 

inspections, exemptions, requests for withholding.” The applicant must request withholding at 

the time it submits the document and must comply with the document marking and affidavit 

requirements in 10 CFR 2.390. The reviewer needs to evaluate the applicant’s request for 

withholding against the requirements in 10 CFR 2.390. Appendix E to this report includes a 

checklist for reviewing requests for withholding information from public disclosure. 

If the request is rejected, in whole or in part, the reviewer needs to give the applicant the option 

to withdraw the information or application. If the applicant decides not to withdraw the 

information or application, the reviewer needs to notify the applicant in writing that the request 

for withholding has been rejected and that the reviewer will disregard any references concerning 

the proprietary status of the information.

Any part of the application that the reviewer has determined should be withheld from public 

disclosure should be handled in accordance with Management Directive 12.6, “NRC Sensitive 

Unclassified Information Security Program,” and the applicant should be notified in writing that 

the NRC plans to honor the request. However, the notification needs to inform the applicant 

that the NRC may have cause to review the determination in the future if, for example, the 

scope of a Freedom of Information Act request includes the information. In all review situations, 

if the NRC needs additional information from the applicant or makes a determination adverse to 

the initial determination, the applicant will be notified in advance of any public disclosure.

NRC/FSME Policy and Procedure 7-4, “Handling Request to Withhold Proprietary Information 

from Public Disclosure” contains guidance for the review and disposition of requests from 

submitters to withhold proprietary information from public disclosure pursuant to 10 CFR 2.390.

Sample letters for approval, rejection, or request for additional information are also included in 

the document. Further guidance is available in NRC Information Notice 2009-07, “Withholding 

Proprietary Information from Public Disclosure.”
33

5.12 Identifying and Protecting Sensitive Information

All licensing applications, except for portions containing sensitive information, will be made 

available for review in the NRC’s Public Document Room and electronically at the NRC Library. 

For more information on the NRC Library, visit www.nrc.gov.

The licensee should identify, mark, and protect sensitive information against unauthorized 

disclosure to the public. Licensing applications that contain sensitive information should be 

marked as indicated below in accordance with 10 CFR 2.390 before the information is submitted 

to the NRC. Key examples are as follows:

• Proprietary Information/Trade Secrets: If it is necessary to submit proprietary 

information or trade secrets, follow the procedure in 10 CFR 2.390(b). Failure to follow 

this procedure could result in disclosure of the proprietary information to the public or 

substantial delays in processing the application.

• Personally Identifiable Information: Personally identifiable information (PII) about 

employees or other individuals should not be submitted unless specifically requested by 

the NRC. Examples of PII are social security number, home address, home telephone 

number, date of birth, and radiation dose information. If PII is submitted, a cover letter 

should clearly state that the attached documents contain PII and the top of every page of 

a document that contains PII should be clearly marked as follows: “Privacy Act 

Information—Withhold under 10 CFR 2.390.” For further information, see Regulatory 

Issue Summary (RIS) 2007-04, “Personally Identifiable Information Submitted to the 

U.S. Nuclear Regulatory Commission,” dated March 9, 2007, which can be found on the 

NRC’s Generic Communications webpage under “Regulatory Issue Summaries”:

http://www.nrc.gov/reading-rm/doc-collections/gen-comm/.

• Security-Related Information: Following the events of September 11, 2001, the NRC 

changed its procedures to avoid release of information that terrorists could use to plan or 

execute an attack against facilities or citizens in the United States. As a result, certain 

types of information are no longer routinely released and are treated as sensitive 

unclassified information. For example, certain information about the quantities and 

locations of radioactive material at licensed facilities, and associated security measures, 

are no longer released to the public. Therefore, a cover letter should clearly state that 

the attached documents contain sensitive security-related information and the top of 

every page of a document that contains such information should be clearly marked: 

“Security Related—Withhold under 10 CFR 2.390.” For the pages having securityrelated sensitive information, an additional marking should be included (e.g. an editorial 

note box) adjacent to that material. For further information, see RIS 2005-31, “Control of 

Security-Related Sensitive Unclassified Non-Safeguards Information Handled by 

Individuals, Firms, and Entities Subject to NRC Regulation of the Use of Source, 

Byproduct, and Special Nuclear Material,” dated December 22, 2005, which can be 

found on the NRC’s Generic Communications webpage under “Regulatory Issue 

Summaries”: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/. Additional 

information on procedures and any updates is available at http://www.nrc.gov/readingrm/sensitive-info.html.
34

5.13 Transportation

This document does not cover detailed requirements for the transportation of devices and 

sealed sources. The NRC’s transportation requirements are established in 10 CFR Part 71, 

“Packaging and Transportation of Radioactive Material.” An application for radiation safety 

evaluation and registration of a sealed source or device as discussed in this document does not 

include a detailed description of packaging and transportation procedures to demonstrate 

compliance with 10 CFR Part 71. 

Any vendor who has questions about the specific requirements for transportation should contact 

the appropriate NRC Region or the NRC’s Rules, Inspection and Operations Branch, Division of 

Spent Fuel Storage and Transportation, at (301) 415-7000 to obtain assistance. Any person 

involved in the transportation of any NRC-licensed radioactive material package must comply 

with the applicable regulations of the U.S. Department of Transportation (DOT). Certificates of 

Compliance for Type B transportation packages can be found at http://www.rampac.energy.gov. 

The DOT approves applications for Special Form Certificates.

Although neither the NRC nor Agreement States evaluate packaging or transportation 

requirements during sealed source or device evaluations, the evaluation does consider the 

effects of the packaging or transportation on the normal use and operation of the product. 

Specifically, the NRC or the Agreement State evaluates the effects of normal conditions 

experienced during transport (e.g., extreme temperatures, vibration) on the sealed source or 

device. Applicants should consider these effects when designing the products and packaging 

for transport.

The packaging certification requirements for Type A packages are ultimately placed on the 

shipper in accordance with 49 CFR Part 173, “Shippers—General Requirements for Shipments 

and Packagings,” Subpart I, “Class 7 (Radioactive) Materials.” The device registration may 

include this information. The NRC evaluates Type B packages separately.
35

6. HOW TO FILE

No special form is required for applications for sealed source or device evaluations. However, 

to facilitate the review process, applicants for a sealed source or device evaluation are 

encouraged to follow the instructions in this chapter. 

6.1 General/Format

To standardize the format of an application for a sealed source or device, applicants are 

encouraged to perform the following steps:

• Review the applicable regulations and use the most recent guidance, including this 

document, in preparing an application.

• Submit all documents, including all drawings if practicable, printed on standard 

8-1/2 inch x 11 inch paper. If the submission of larger documents is necessary, the

documents should be folded to 8-1/2 inches x 11 inches.

• Number all pages in an application, consecutively. If revisions are necessary after an 

application has been submitted, submit revised or replacement pages that show the date 

of the revision or the revision number. Indicate supplemental pages submitted for 

insertion alphanumerically (e.g., 12a, 12b).

• Submit an original, signed application. Include an electronic copy when feasible. Retain 

a copy of the registration application for future reference.

• Licensees may use electronic means such as CD-ROM and e-mail to communicate with 

the agency. The rule on the electronic maintenance and submission of information 

(10 CFR Chapter I) (ADAMS Accession No. ML032580290) became effective on 

January 1, 2004.

6.2 Content

To standardize the content of an application for a sealed source or device, applicants are 

encouraged to perform the following steps:

• Complete the “Summary Data” section of the form in Appendix A of this report.

• Attach the balance of the application to the “Summary Data” information. The order of 

the information in the application should correspond to the appropriate subsection in 

Chapter 10, “Application and Review Process,” of this report.

• Use the checklist included in Appendix A as a guide to determine whether all necessary 

information has been provided.

• Include drawings, no larger than about 4 inches x 6 inches, that are suitable for inclusion

in the registration certificate and that provide an overall representation of the product 

and its safety features. The NRC and the Agreement States prefer both paper copies

and electronic versions of the labels, diagrams, and photographs that are intended for 

insertion into the registration certificate
36

• Identify drawings, descriptive sales literature, or similar documents when they are 

submitted as part of an application, such as by marking the materials individually and 

listing them on a cover sheet for the application or listing them as enclosures to the letter 

that transmits the application.

• Submit a copy of the user operating manual and safety instructions. In accordance with 

10 CFR 32.210(c), these documents should provide the end user with “sufficient 

information about installation, service and maintenance, operating and safety 

instructions, and its potential hazards, to provide reasonable assurance that the radiation 

safety properties of the source or device are adequate to protect health and minimize 

danger to life and property.

• Identify the safety-related components and assembly methods used to contain and 

shield the source of radiation. Submit the engineering drawings as identified in 

Section 6.3, “Engineering Drawings.”

• Address the safety-related items in the applicant’s QA/Quality Control (QC) program to 

identify potential defects or noncompliance during the fabrication process.

Avoid submitting proprietary information unless it is absolutely necessary. If it is necessary to 

submit proprietary information, follow the procedure in 10 CFR 2.390 and see Section 5.11, 

“Proprietary Information,” of this document for additional details.

• Include a clear, concise presentation of the information necessary for the evaluation, 

avoiding ambiguous and conflicting statements and wordy descriptions that do not 

contribute to a technical review.

• Use terms in the application as they are defined in NRC regulations and national 

consensus standards, as applicable. Define all abbreviations and acronyms.

6.3 Engineering Drawings

The engineering drawings that are submitted with an application should include safety-related 

details; they should not be fabrication-level drawings. The drawings should include the following 

details:

• A drawing number, revision number, company name, title, scale, and date, clearly 

indicating references to parts or other drawings and whether drawings have been 

reduced or enlarged.

• One or several isometric projection diagrams showing components pertinent to radiation 

safety, such as shielding material; shielding thickness; on/off mechanisms and 

indicators; label location; assembly methods; source mounting and safety and 

dimensions, tolerances, and materials of construction suitable for insertion in a source or 

device registration.

• Overall details of the safety-related components (e.g., outer housing, secondary 

shielding, C-frames, and environmental control systems).

• Complete details for safety-related components (e.g., primary containment, primary 

shielding, safety features, regulatory requirements).
37

• Materials of construction (e.g., raw materials, manufactured components, 

dimensions/tolerances, assembly methods (welds, bolts, screws), and 

manufacturing/production processes).

• Data sheets on the chemical, physical, and mechanical properties of materials with a 

foreign designation.

• Function/operation of the product.

• Safety features (e.g., return springs, interlocks).

• On/Off mechanisms and indicators.

• Source containment and shielding, including movement (e.g., shutters, movable source).

• Installation and mounting (including whether the device is fixed, mobile, or portable).

• Accessibility of the radiation beam during use (including air gaps that could allow 

radiation exposures and barriers/guards).

• Tamper-resistant construction/hardware.

Engineering drawings should be in English. To facilitate preparing an application on a product 

manufactured outside the United States, the applicant may elect to write or otherwise affix the 

English translation directly on an engineering drawing.

It may be advantageous to submit the product (without radioactive material) or a part of the

product with the application. For example, a vendor of radiography equipment may elect to 

submit a “pigtail” connector (used to join the source assembly to the drive cable) as a means of 

clarifying the related engineering drawings and operating instructions. Large pieces of 

equipment should not be submitted because of handling and storage limitations at the NRC 

offices.

If it is necessary to submit proprietary information, follow the procedure in 10 CFR 2.390 and 

see Section 5.11, “Proprietary Information,” of this document for additional details.

Applications may be scanned or put through an optical character reader to convert them to 

electronic format. To assist with the conversion of the application to electronic media, 

applicants should follow these suggestions:

• Submit printed or typewritten, not handwritten, text on smooth, crisp paper that will feed 

easily into a scanner.

• Be sure the print is clear and sharp.

• Be sure there is high contrast between the ink and paper (black ink on white paper is 

best).

39

7. WHERE TO FILE

Applicants located in States or territories subject to NRC jurisdiction wishing to register a sealed 

source or device may file an application with the NRC by submitting the application to the 

following address:

U.S. Nuclear Regulatory Commission

Licensing Branch

Office of Federal and State Materials and Environmental Management Programs

ATTN: SSDR

Washington, DC 20555-0001

Please note that the above address is different from that of the appropriate NRC Region to 

which persons would apply for authority to possess and use radioactive material under a 

manufacturing and distribution license.

The above address cannot accept mail requiring the receiver’s signature (e.g., express mail). 

Mail requiring the receiver’s signature should be sent to the following address:

U.S. Nuclear Regulatory Commission

Office of Federal and State Materials and Environmental Management Programs

Division of Materials Safety and State Agreements

Licensing Branch

Two White Flint North

11545 Rockville Pike

North Bethesda, MD 20852-2738

Applicants in locations subject to Agreement State jurisdiction who wish to apply for safety 

evaluation and registration of a sealed source or device should file the application with the 

appropriate Agreement State agency, not the NRC. However, some Agreement States do not 

issue registration certificates. Chapter 2, “Agreement States,” of this report identifies which 

Agreement States do not issue registration certificates. 

41

8. REGISTRATION FEES

Each application for which a fee is specified must be accompanied by the appropriate fee, 

including applications for new registration certificates. Refer to 10 CFR 170.31, “Schedules of 

fees for materials licenses and other regulatory services, including inspections, and import and 

export licenses,” to determine the amount of the fee . The NRC will not issue the registration 

certificate until the fee is received. Consult 10 CFR 170.11, “Exemptions,” for information on 

exemptions from these fees. Once the technical review process has begun, no fees will be 

refunded; application fees will be charged regardless of the NRC’s disposition of an application 

or the withdrawal of an application. Currently, no fees are required for amendments of 

registration certificates.

Most NRC registration certificate holders are also subject to annual fees; refer to 

10 CFR 171.16, “Annual fees: Materials licensees, holders of certificates of compliance, holders 

of sealed source and device registrations, holders of quality assurance program approvals, and 

government agencies licensed by the NRC.” Consult 10 CFR 171.11 for information on 

exemptions from annual fees and 10 CFR 171.16(c) on reduced annual fees for registration 

certificate holders that qualify as “small entities.”

Direct all questions about the NRC’s fees to the Office of the Chief Financial Officer (OCFO) at 

NRC Headquarters in Rockville, MD, (301) 415-7554. Information about fees may also be 

obtained by calling NRC’s toll free number, (800) 368-5642, extension 415-7554. The e-mail 

address is Fees.Resource@nrc.gov.

43

9. DOCUMENT FLOW

9.1 Application Receipt and Assignment to a Reviewer

Applicants usually submit requests for safety evaluations of sealed sources or devices directly 

to FSME/MSSA or the Agreement State. However, applications may be submitted to other NRC 

divisions or offices (e.g., as part of a licensing action) and forwarded to MSSA as a technical 

assistance request. For example, the NRC Regions and other divisions within FSME may 

receive requests as part of a license request, or the OFCO may receive a request to make a 

registration certificate inactive. The processing of the application is the same in all cases.

NRC staff submitting technical assistance requests concerning sealed source and device issues 

to MSSA should follow the procedures in NUREG 1556 Volume 20, “Guidance about 

Administrative Licensing Procedures.”

When the NRC or the Agreement State receives an application, an acceptance review may be 

performed to determine whether the application contains sufficient information to initiate a 

review. If the information is not sufficient, the entire package may be returned to the applicant 

for resubmission of a complete application.

As specified by the internal procedures of the NRC, applications are logged into the sealed 

source and device action tracking system to await assignment to a reviewer. Each action 

receives a unique tracking number. Assignment to a reviewer is determined on a first-in basis. 

An application may be assigned a higher priority based on the dire need for the product to 

protect public health and safety, the product providing a currently unavailable benefit to society, 

or commercial hardship that is likely to be experienced by the applicant if the evaluation process 

is delayed. Requests for higher priority should include adequate justification.

While an application is awaiting assignment to an NRC reviewer, OCFO receives copies of the 

cover letter to the application and of NRC Form 567 for verification that the appropriate 

application fees have been received. OCFO will return NRC Form 567 to MSSA indicating 

whether the appropriate fees have been collected. MSSA may start an evaluation of a sealed 

source or device before fees are collected; however, the NRC will not issue a final approval of 

the product until the application fees are paid in full.

9.2 Expedited Reviews

9.2.1 NRC-Expedited Reviews on the Basis of National Security

The NRC will give an application high priority and expedite the review if the product or device is 

necessary for protecting national security. The following five criteria should be met for a review 

to be expedited:

(1) The U.S. military or a Federal agency (e.g., U.S. Customs and Border Protection, 

Federal law enforcement agencies) makes a request for expedited review directly to the 

NRC.

(2) The appropriate agency official makes a request in writing (e-mail is acceptable) to the 

appropriate Branch Chief or higher level management.
44

(3) The requesting agency should state that national security is at stake and briefly, and in 

general terms, describe the use of the product. A detailed description that could 

disclose sensitive information is not necessary. The NRC will expedite the review for 

security reasons, not for business reasons.

(4) There is no alternative product, an alternative product would be too costly, or the pursuit 

of an alternative product would result in significant setbacks to plans or schedules.

(5) The requesting agency commits to providing the necessary oversight of the applicant to 

ensure both of the following:

a. The application is of sufficient quality and provides the necessary information to 

support an expedited review.

b. The applicant is responsive to NRC requests for information.

In conducting the review, NRC reviewers should be able to conclude, with reasonable 

assurance, that regulatory requirements are met. However, the rigor of the review should be 

commensurate with the risk that the product poses to public health and safety. The reviewer 

should exercise engineering judgment.

9.2.2 NRC-Expedited Reviews for Reasons Other than National Security

An application may be assigned a higher priority upon request. Requests for higher priority 

should include adequate justification as indicated. The company president or chief executive 

officer of the applicant should make the request in writing to the appropriate NRC manager and 

include the following information:

• If the justification for expedited review is the dire need for the product to protect public 

health and safety, the request should indicate that the product provides a currently 

unavailable benefit to society. The applicant should provide details of the need, 

including (1) who directly benefits from the use of the product, (2) how they benefit, 

(3) how existing products fail to provide that benefit, (4) why the review must be 

accomplished in less than the normal review time, and (5) when the product is needed.

• If the justification for expedited review is commercial hardship, the request should

describe the commercial hardship that the applicant is likely to experience if the 

evaluation process is delayed. The applicant should provide details of the hardship, 

including (1) who is affected by the hardship, (2) how they are affected (e.g., bankruptcy, 

layoffs) and why completion of the action is the only way to avoid that effect, (3) why the 

review should be accomplished in less than the normal review time, and (4) when it is 

needed.

9.3 Responsibilities of the Reviewer

The reviewer is responsible for performing the technical evaluation of the product, ensuring that

the product meets all applicable standards and regulations, corresponding with the applicant to 

obtain additional information if necessary, generating the registration certificate, and ensuring

that the application is reviewed and signed by two persons having signature authority. In 

addition, the reviewer needs to identify any complex policy issues and bring them to 

management’s attention.
45

In some cases, the adequacy of an element of the product design may not be readily evident. 

As a result, the reviewer may need to exercise professional judgment about the adequacy and 

safety of the product design. The reviewer should discuss such judgment with the applicant and 

document it in a note to the registration file. 

Once the evaluation is complete and if a registration certificate is issued, the reviewer should 

send a copy of the registration certificate to the applicant. The reviewer should forward the 

registration certificate (including a cover letter to the applicant and a technical assistance 

request response, if applicable) and all information used in support of the evaluation to the 

registration assistant for distribution and filing.

Chapter 2, “Agreement States,” of this report discusses the NRC’s role in the review of 

Agreement State registration certificates.

9.4 Inclusion in the Sealed Source and Device Computerized Registration 

System

All newly issued registration certificates are submitted by the issuing agency to the NRC to be 

added to the NSSDR. Once in the system, certificate information can be located by searching 

on any item that is included in the certificate (see Section 12.2, “First Page Information,” of this 

report). The FSME Web site contains the registrations at http://nrc-stp.ornl.gov/ssdr.html.

Access to the computerized registration system is limited to NRC and select Agreement State 

staff for licensing and inspection activities.

Members of the public, who need a copy of the registration certificate, should contact the 

manufacturer/distributor of the sealed source or device.

47

10. APPLICATION AND REVIEW PROCESS

Applicants requesting safety evaluations and persons who evaluate the adequacy of products 

should address the items discussed in this chapter to verify that the applicant has submitted 

sufficient information and to determine whether the design of the product is adequate for its 

proposed uses.

Applicants are encouraged to follow the instructions in Chapter 6, “How to File,” and use 

Appendix A to this report as a guideline when submitting applications. Applicants may complete 

the “Summary Data” section of the form in Appendix A and use the checklist in the appendix to 

ensure that they have addressed all items listed in this chapter. The balance of the application 

should be attached to the copy of the form in the appendix. Reviewers may opt to use the 

checklist to verify that the applicant has addressed all items listed in this chapter.

Note that certain regulations include specific requirements applicable to the evaluation and 

registration of products. Chapter 4, “Applicable Regulations,” lists these regulations, and each 

regulation also is listed at the end of the applicable topic discussion in this chapter. The 

regulatory requirements take precedence over the general guidance provided in this document. 

Applicants must ensure, and reviewers must verify, that all regulatory requirements are met.

The checklist in Appendix A is not considered an all-inclusive review document. It is designed 

to highlight important aspects of the application. Further detail on and review of specific areas 

of the application may be necessary.

10.1 Summary Information

10.1.1 Manufacturer and Distributor

Applications must include the complete names and addresses of both the manufacturer and 

distributor of the product. The same person may be both the manufacturer and the distributor. 

However, if different, the distributor should apply for the evaluation. The distributor will be 

responsible for meeting the requirements associated with the registration, whether the 

information is supplied by the distributor or by the manufacturer on behalf of the distributor.

In some cases, a manufacturer may distribute the product(s) through more than one distributor. 

Foreign manufacturers may also use more than one distributor for marketing their products in 

the United States. In such cases, the NRC issues a separate vendor code and registration 

certificate to each of the distributors in order to distinguish between them and maintain 

traceability of the product(s). Appendix B to this report provides further details on vendor codes. 

The reviewer should obtain a commitment from the distributor that each product will be 

distributed with a unique serial number. 

Distribution activities are normally classified as either “distribution” or “redistribution.” 

“Distribution” applies to those sealed sources or devices initially manufactured or transferred (or 

both), under 10 CFR Part 32 or under equivalent Agreement State requirements, by the 

manufacturer for use or resale. Distribution requires evaluation and registration of the product 

according to the guidance in this document. “Redistribution” refers to those materials received 

from the initial manufacturer/distributor and transferred to another person licensed to possess 

the product without any alteration of the product, labeling, packaging, or other contents. 

Redistribution generally does not require a separate evaluation/registration of the product since
48

no alteration to the product occurs with this authorization. If a person wishes to alter the design, 

labeling, packaging, or other contents of the package, or if one wishes to refurbish existing 

devices that have been previously registered, the person must obtain specific approval from the 

NRC in the form of a specific license and separate evaluation/registration of the sealed source 

or device.

For redistribution of sealed sources or devices, the reviewer should confirm the following:

• Sealed sources or devices to be redistributed will be obtained from a person licensed,

pursuant to 10 CFR 30.41, “Transfer of byproduct material,” or 10 CFR 32.74 or under 

equivalent Agreement State requirements, to initially distribute such sources.

• The original design, labeling, packaging, and other contents will not be altered, and 

redistributed products will be accompanied by the manufacturer-supplied calibration 

certificate and the leaflet, brochure, or any other document that provides radiation safety 

instructions for handling and storing the product.

Remanufactured products, or products with replacement parts identical to the original, can only 

be distributed under the registration certificate if they are in conformance with the statements 

and commitments made in support of the registration certificate. When the remanufacturing 

process introduces components or fabrication methods that differ from those that were used for 

the issuance of the registration certificate, the licensee must request an amendment of the 

registration certificate or apply for another registration. 

10.1.2 Custom User

Applications should indicate whether the product is intended for use by a custom user. The 

custom user must be identified by name and complete address. Section 5.2, “Custom Users,”

provides additional information on custom users.

A product specifically designed and constructed to the order of a single licensee may be 

considered a custom product. Since there is a single user of the product, the NRC can 

appropriately consider specific departures from accepted standards from the point of view of 

compensating qualifications or conditions of use for the particular licensee. Usually, these 

departures occur in the areas of prototype testing and QC procedures.

10.1.3 Other Companies Involved

The application should include the name, complete mailing address, and function of all other 

companies involved in the manufacture and distribution of the product.

10.1.4 Model Number, Sealed Source or Device Type, and Principal Use Code

The regulations in 10 CFR 30.32(g)(1) requires the licensee to identify the source or device by 

manufacturer and model number as registered under 10 CFR 32.210. For this reason, the 

application must clearly state the model number designation for the product. This model 

number will be listed on the registration certificate for the product and may be listed on licenses 

of persons applying to use the product. The NRC and Agreement States use the model number

to uniquely identify the product.
49

An applicant may request to have a model listed as a series. In order to have the model listed 

as a series, the design and construction of the models in the series should have similarities. 

Applicants should provide detailed engineering drawings of each basic source or device series 

that contain overall dimensions, maximum and minimum dimensions, tolerances, materials of 

construction, and differences between models in the series.

The application needs to identify the sealed source or device type as used by the industry 

(e.g., a level gauge, radiography device, self-shielded irradiator, teletherapy unit) and the 

principal use code that most accurately describes the product. Appendix C to this report lists

principal use codes. This information assists applicants and reviewers in determining the 

applicable regulations, codes, and standards that affect product registration. The application 

also must identify whether the device is intended to be used under a specific license, general 

license, either a specific or general license, or by persons exempt from licensing requirements. 

If applicable, the applicant and reviewer need to determine which general license or exemption 

applies for possession and use of the product. The applicant must provide the information

needed to make this determination. Section 10.2, “Conditions of Use,” discusses this further and

addresses the product’s conditions of use.

10.1.5 Radionuclides Used in the Product

The applicant must identify all radionuclides that will be used in the product and include the 

maximum requested activity for each, including loading tolerance. The application must also 

include the form of the byproduct material, including contaminates or impurities, if applicable. 

Applicants need not provide information on contaminates or impurities that have little effect on 

the radiation levels from the sealed source or on how the sealed source will react under extreme 

environmental conditions.

For evaluations of devices, the applicant must identify whether the associated sealed source is 

currently registered. If so, the applicant must identify the model number designation and the 

manufacturer or distributor of the sealed source, as listed on the registration certificate for the 

sealed source.

10.1.6 Registration of Sources as Part of a Device

If the sealed source is not currently registered, the sealed source must be registered separately 

or as part of the device. In either case, the applicant must submit sufficient information to 

register the sealed source, and the reviewer must perform a complete evaluation of the sealed 

source. If the sealed source is registered as part of the device, the registration certificate for the 

device should note that the sealed source is not registered separately, is registered as part of 

the device, and is approved only for use in the device.

10.1.7 Leak Test Frequency

The applicant must provide the maximum time interval between leak tests to be performed on 

the product. Typically, products must be leak tested at intervals not to exceed 6 months. Leak 

test procedures must be capable of detecting the presence of 185 becquerels (Bq) (0.005 μCi) 

of removable contamination.

Products containing only krypton-85, hydrogen-3 (tritium), radioactive gas, isotopes with 

half-lives of 30 days or less, beta- or gamma-emitting material of no more than 3.7 MBq 

(100 μCi), or alpha-emitting material of no more than 370 kilobecquerels (10 μCi) are exempt 
50

from periodic leak testing requirements. However, a leak test should be performed before initial 

distribution of the product.

Devices may be approved with leak test intervals greater than 6 months if sufficient information 

is submitted to justify such a request. The regulations in table 10.1 below should be referenced 

for additional information about leak testing.

Table 10.1: Leak Testing Requirements

Regulations

Applicability

10 CFR 32.51(b)

10 CFR 31.5(c)(2) – (4)

Devices used under the 10 CFR 31.5 general license

10 CFR 34.27 Sources and devices designed for use in radiography 

operations

10 CFR 39.35 Sources used in well-logging operations

10 CFR 36.59 Irradiator operations

10 CFR 35.67(f)(1)-(5) Brachytherapy Sources for Medical Use

10 CFR 32.74(b) Sources or devices for medical use

10.1.8 Certification and Signature of a Management Representative

Individuals acting in a private capacity are required to date and sign the application. Otherwise, 

representatives of the corporation or legal entity filing the application should date and sign the 

application. Representatives signing an application must be authorized to make binding 

commitments and to sign official documents on behalf of the applicant. As discussed previously 

in Chapter 3, “Management Responsibility,” signing the application acknowledges 

management’s commitment and responsibilities for the regulatory requirements. The NRC will 

return all unsigned applications for a proper signature.

All representations made in the application are considered commitments for the manufacturing 

and distribution of the product. Therefore, those items become part of the 

manufacturing/distribution license conditions and are subject to regulatory requirements.

10.2 Conditions of Use

The applicant must address, and the reviewer must evaluate, the issues listed under 10 CFR 

32.210 (c) and (d), such as the intended use and users of the product and which standards, 

policies, and regulations are applicable. Applicable standards or regulations may specify 

prototype testing, labeling, design, maximum external radiation levels, maximum dose 

commitments, QA/QC, or leak testing requirements.

The discussion on the intended use of the product should describe the types of users, the 

locations of use, the occasions when persons will be near the device and the frequency of these 

occasions, and the possibility that the device may be used as a component in other products.
51

The applicant and reviewer must also evaluate the likely environments to which the product will 

be subjected during normal use and likely accident conditions. Normal use and likely accident 

conditions should include those experienced during use, handling, storage, and transportation 

(extremes experienced during accident conditions during transportation need not be 

considered). The applicant and reviewer need to evaluate whether the product will be subject to 

extreme conditions of corrosion, vibration, impact, puncture, compressive loads, explosion, 

flooding, poor air quality, excessive high or low temperatures, change in temperature 

(i.e., thermal cycling), and cycling of the on/off mechanism.

The applicant should provide the estimated working life of the product in terms of time, 

operational cycles, or other applicable limiting conditions. The reviewer should conduct a safety 

and risk study of the product’s estimated working life to determine whether the estimate is 

justified based on the information submitted. Inclusion of the working life of the product is 

important because the working life provides an indication of when servicing or reevaluation of 

product integrity may be necessary.

10.3 Construction of the Product

Applicants need to describe construction aspects of the product, including components of the 

product, materials of construction, dimensions, assembly methods, source containment and 

shielding, and operation of the product and its safety features. The application should include a 

brief written description and summary of the construction aspects as well as specific, detailed 

descriptive data such as engineering drawings and product specification sheets.

The brief written description and summary of the construction aspects should include 

information on the following:

• overall operation of the product

• identification of primary components and safety features

• type of installation, including method of attachment to its mounting if installed in a fixed 

location and the means of relocation if portable

• primary construction materials used for the product’s structure and integrity and for its 

safety features

• accessibility of the radiation beam during use

• means of providing containment, radiation safety , and shielding of the radiation source,

including shutters or other movable shielding

• location and operation of on/off or shielded/exposed indicators

• identification of other design features that protect the product from abuse or tampering

The identification of the product’s components and safety features should include a description 

of the purpose, function, and operation of each. An overall drawing of the product, identifying 

primary components and safety features and indicating overall dimensions, is useful as a 

complement to the written description of the product and for providing an understanding of the 

operation of the product.
52

Detailed design and construction data should be sufficient to allow the reviewer to fully 

understand the construction and operation of the product and its components and safety 

features and to evaluate the product’s safety and integrity. This should include complete 

annotated engineering design or construction drawings (or both) of all safety-related

components, specification sheets, materials lists, and/or detailed written descriptions. The 

applicant should describe in detail the mounting and integrity of the radioactive material or 

sealed source in the product.

Drawings of safety-related parts and components should (1) be fully dimensioned with 

tolerances, (2) include identification of the safety-relatedl parts, (3) indicate the materials of 

construction or refer to a materials specification sheet or list, (4) indicate fabrication and 

assembly methods, and (5) include a drawing number and revision date or number. Parts 

related to safety include those parts or components that provide primary containment, safety, 

and shielding of the radioactive material or sealed source. Applicants should also provide

drawings and descriptions of nonsafety-related components and parts that contribute to the 

product’s safety or integrity or both. These drawings should include sufficient descriptive 

information to determine how the components contribute to the safety and/or integrity of the 

product, how the component is integrated with other components of the product, and whether

the nonsafety-related components could degrade the effectiveness or usefulness of 

safety-related components.

The applicant should describe all special design features that protect the product from abuse, 

control the hazard from direct or scattered radiation, and discourage unauthorized access to the 

source. The application should address accessibility of the radiation beam during use, including

the size of openings or air gaps that could allow any part of a human body to enter the radiation 

beam, and any protective measures, additional guards, or installation requirements designed to 

prevent accessibility of the radiation beam during use.

The reviewer must evaluate how the product is constructed and its integrity. The reviewer must

be able to determine the construction of the product from the drawings and written description 

provided with the application. During the evaluation of product integrity, the reviewer needs to 

ensure the following:

• The assembly methods (e.g., welds, bolts, screws), including size, materials, and 

spacing, and materials of construction of the device are sufficient to withstand normal 

use and likely accident conditions. These include being subjected to corrosive 

environments, vibration, impact, puncture, compressive loads, explosion, flooding, 

excessive high or low temperatures, drastic changes in temperature (i.e., thermal 

cycling), and cycling of the on/off mechanism.

• If construction includes the use of dissimilar materials, the materials are compatible and 

corrosion is not likely to occur because of contact between the unlike materials 

(e.g., corrosion is likely when you have direct contact between aluminum and steel, or 

depleted uranium and steel. In addition, the materials will not cause corrosive 

environments without direct contact (e.g., Teflon can break down when subjected to 

radiation and cause a corrosive environment for certain metals).

• Exposure to radiation and to the expected conditions of use will not be detrimental to the

materials of construction (e.g., adhesives, lubricants, and gaskets).
53

• The assembly methods will have no detrimental effects on the product during its 

fabrication (e.g., heat from welding a holder directly to the sealed source, securing the 

sealed source by tightening a screw or bolt against the wall of the sealed source).

• The fixed shielding will not move nor easily become dislodged from the device.

• The mounting of the sealed source is such that the sealed source will not unintentionally 

move during use nor become dislodged from the device, and the mounting sufficiently 

secures the sealed source against access by unauthorized users.

• All moving parts have adequate spacing to ensure that they will not bind during use. 

The tolerances of the spacing between the parts should be such that likely changes 

(e.g., from bending, temperature changes causing expansion or contraction, introduction 

of foreign materials) will not cause binding that may lead to unintentional exposure of the 

source.

• The device can be locked in the closed condition (source fully shielded) and cannot be 

locked in the open condition, if applicable.

• The device contains indicators that clearly identify whether the source shielding is in the 

open or closed position. If colors are used to identify the open or closed conditions, red 

should be used for the open condition where exposure could occur and green should be 

used for the closed condition where the source is “safe” in the shielded position.

• Sufficient safety interlocks, barriers, or guards are included to prevent access to the 

radiation beam and to prevent exposures in excess of those specified in the regulations 

(the inclusion of barriers or guards should be included as reviewer notes to alert license 

reviewers). 

• If pneumatic or hydraulic systems are used, there are appropriate filtration, relief valves, 

and operating pressures.

• The operation is designed to be fail-safe; that is, loss of power or a failure in the system 

would cause the shutter to return to, or remain in, the fully shielded position.

• If applicable, the design of the device uses tamper-resistant hardware or assembly 

methods. Typically, this is required for devices used by general licensees and persons 

exempt from licensing.

• If applicable, the device is hermetically sealed from foreign materials or moisture.

• Sealed sources contain appropriate internal void spacing to ensure accurate leak testing 

results, if applicable. In addition, void spacing should allow for any thermal expansion of 

the materials.

• Important note for reviewers: Some devices are distributed as both specifically licensed 

and general licensed devices. For these devices, the reviewer should clearly differentiate 

between the specifically licensed design and the generally licensed design in the 

registration certificate. These differences can include, for example, description of

tamper proofing, labeling, and other applicable features.
54

Product integrity does not necessarily mean that the product will perform its intended uses after 

it is subjected to an accident or unlikely use conditions. However, the product should still 

ensure that the byproduct material is not dispersed, the source capsule remains within the 

protective source housing, and the shielding integrity is not compromised. Typically, an 

increase in radiation of greater than 20% constitutes a compromise of the shielding integrity.

If the request is for an amendment to a source or device model, or if the model is substantially 

similar to another model, the reviewer should check the NRC’s NMED for events involving the 

source or model for potential safety issues to address during the review process. These models 

may be within the same model family, or the application may be referencing a substantially 

similar model in the prototype testing section. 

The regulations in table 10.2 below should be referenced for additional information about

product designs.

Table 10.2: Design Requirements

Regulations

Applicability

10 CFR 30.19(a) and (c) 

10 CFR 32.22(a)

Devices used under the 10 CFR 30.19 exemption

10 CFR 30.20(a), 

10 CFR 32.26

Devices used under the 10 CFR 30.20 exemption

10 CFR 30.22 (a)

10 CFR 32.30 (b)

Devices used under the 10 CFR 30.22 exemption

10 CFR 31.5(a), 

10 CFR 32.51(a)(2)

Devices used under the 10 CFR 31.5 general license

10 CFR 32.53(c) and (d) Devices used under the 10 CFR 31.7 general license

10 CFR 32.61(c) and (e) Devices used under the 10 CFR 31.10 general license

10 CFR 34.20, 10 CFR 34.23 Sources and devices designed for use in radiography 

operations

10 CFR 39.41(a)(1) and (2) Sources used in well-logging operations

10 CFR 36.21(a)(2)(3) and (4) Sources used in irradiator operations

Design requirements for exempt products and for devices to be used under the general license 

in 10 CFR 31.5 include dose criteria. Therefore, the application for these products must also 

include dose assessments for both normal use and likely accident conditions. Dose 

assessments must be consistent with the information submitted about such matters as design, 

construction, working life, and conditions of use.
55

10.4 Labeling

Applicants must provide a description of the labeling of the product, including information 

contained on the label, materials of construction of the label, and how and where the label is 

attached. The labeling should be sufficiently durable to remain legible for the useful life of the 

product under normal conditions of use and, for devices, should be in a readily visible location. 

Applicants should provide samples or copies of the labels as part of the application.

The reviewer must verify that the application includes sufficient information about the product

labeling. In addition to applicable regulatory requirements, applicants and reviewers should 

follow the guidelines outlined below for labeling of products.

10.4.1 Devices

Label devices with the following, as suggested:

• model number, serial number, isotope, activity, distributor’s name, date of assay, and the 

trefoil symbol or the words “CAUTION—RADIOACTIVE MATERIAL”

9 (or both)

• a statement that the product contains depleted uranium as shielding and include the total 

weight of the uranium, if applicable

• limiting conditions of use or other information necessary for the safe use of the product, 

such as servicing instructions, if applicable

10.4.2 Sealed Sources

Labels for sealed sources should include the same information as on a device. However, 

because of the size of the source, all of the information may not fit. Therefore, the label should 

contain as much of the information as possible, with the importance of the information serving 

as the criterion for inclusion. Final approval of the information is left to the discretion of the 

reviewer. The label should include the following information, in order of importance and with a 

description of why the information should be displayed:

• Trefoil Symbol or the Words “CAUTION—RADIOACTIVE MATERIAL” (or both): This 

information is important if a member of the public finds the source because it alerts the 

person finding the source that it contains radioactive material. The trefoil symbol is fairly 

well recognized. Therefore, for small sources where all the information may not fit, the 

symbol is probably more important than the words “CAUTION—RADIOACTIVE 

MATERIAL.”

• Serial Number: The serial number can usually be traced back to determine the original 

activity, isotope, date of assay, and the last known user of the source. The current 

activity can be calculated, given this information. However, to trace the serial number

back to this information, either the vendor or the last person possessing the source must 

be known and in business. The serial number may be important for sources that would 

be stored in large quantities. This would assist the licensee in maintaining accountability 

of each source.

 9

 The word “danger” may be used in lieu of the word “caution.”
56

• Distributor’s Name or Logo: This information is important when trying to locate additional 

information about the source. Information about the distributor resides in the NSSDR. 

The registration certificate may also identify alternate distributors.

• Model Number: The NRC includes the sealed source model numbers in the NSSDR. 

Therefore, given the model number, the NRC could identify the distributor, possible 

isotopes, and maximum allowable activities.

• Isotope, Activity, Date of Assay: This information could assist trained personnel in 

responding to an incident involving the source. However, this information could be 

obtained from other data included on the source, as indicated above, or by analysis and 

from surveying radiation levels around the source.

The reviewer must evaluate whether the labeling is durable, will remain on the product, and will 

remain legible under normal use conditions throughout the working life of the product.

Engraving or laser etching the information is the preferred method for labeling sealed sources. 

For devices, the preferred method is a metal label, with the information engraved or etched into 

the label, and the label attached to the device with screws or rivets. Other materials and 

methods may be acceptable, depending on the likely environments in which the product will be 

used.

Labels must be placed so that they are easily visible to the users of a device. The labels

should also be designed so that they stay attached to the part of the device that contains the 

radioactive material. The labels should not be attached to the detector housing or to a barrier 

or guard. The applicant may elect to have additional labels on the detector housing or on 

barriers or guards.

The reviewer needs to verify that the labeling does not misinterpret, misrepresent, or lead the 

user into violating any applicable regulations. For example, devices distributed to specific 

licensees must not include statements concerning use of the device under a general license.

The regulations in table 10.3 below should be reviewed for additional information about product 

labeling.
57

Table 10.3: Labeling Requirements

Regulations Applicability

10 CFR 32.22(a)(2)(x),

10 CFR 32.25(b)

Devices used under the 10 CFR 30.19 exemption

10 CFR 32.26(b)(10),

10 CFR 32.29(b)

Devices used under the 10 CFR 30.20 exemption

32.30(b)(10) and 32.32(b) Devices used under the 10 CFR 30.22 exemption

10 CFR 32.51(a)(3)-(5) Devices used under the 10 CFR 31.5 general license

10 CFR 32.54 Devices used under the 10 CFR 31.7 general license

10 CFR 32.61(b)(6) and (d) Devices used under the 10 CFR 31.10 general license

10 CFR 34.20 Source and devices designed for use in radiography operations

10 CFR 39.31(a) Sources used in well-logging operations

10 CFR 32.74(a)(2)(vii) and 

(viii) and (a)(3)

Sources and devices for manufacturing medical products

10.5 Prototype Testing

An applicant must provide information that verifies that the product design will maintain its 

integrity when subjected to conditions of normal use and likely accident conditions. Normal use 

and likely accident conditions should include those experienced during installation, use, 

handling, maintenance, storage, and transportation (only normal conditions during 

transportation need to be considered). Applicants need to determine an appropriate method to 

demonstrate the product’s ability to maintain its integrity when subjected to conditions of normal 

use and likely accident conditions. This may include the following:

• Testing a prototype of the product. A prototype product must be a complete 

representation of the final product that includes all safety features, shielding, safety 

markings (if appropriate), and any accessory features or mounting that may have a 

detrimental effect to the safety and integrity of the product when subjected to normal or 

likely accident conditions. Prototypes must be constructed from the same materials and 

to the same dimensions and tolerances as the final product, but the prototype may be a 

scale representation of the final product. Any variations of the prototype product from 

the final product must be analyzed for the effect on the test results that the change 

would be expected to cause (see the discussion of an engineering analysis, below).

• Performing an engineering analysis. An engineering analysis could be conducted in lieu 

of actual testing unless actual testing is required by the regulations. An engineering 

analysis consists of a detailed, systematic analysis of the product’s design and materials 

of construction and the processes used in manufacturing the product to determine the 

product’s ability to maintain its integrity when subjected to normal and likely accident 

conditions. The analysis may consist of calculations, modeling, sample testing, and 

evaluation. In addition, when evaluating products for which an industry standard is 
58

applicable, an engineering analysis may be used to demonstrate that the item would 

successfully pass the standard tests, if it were subjected to the tests. The conclusions of 

an engineering analysis should be fully justified with supporting documentation 

describing the analysis and including calculations or other applicable reference material.

• Operational history of the product. Operational history can cover identical devices 

(excluding accessory equipment that has no effect on the safety or integrity of the 

product) used in equivalent or more severe conditions of normal use. This typically 

includes products used in the United States as a custom product or in another country. 

Operational history should include the environmental and operating conditions, numbers 

of cycles per year, the results of any known accident conditions, the results and root 

causes of any known product failures, and the years of use of the product. Operational 

history must be sufficient to demonstrate that the product would be expected to operate 

safely and maintain its integrity during the product’s intended normal conditions of use. 

In addition, if operational history is sufficiently comprehensive, it may also be used to 

demonstrate product integrity for likely accident conditions. However, a product’s 

operational history would not be sufficient to demonstrate the product’s ability to operate 

safely or maintain its integrity if it has never been subjected to the extremes of expected 

normal use or likely accident conditions.

• Comparison to a similar or equivalent model previously reviewed and registered. 

Information about a similar or equivalent product may be used to demonstrate safety or 

integrity of the requested product, if the design of the similar or equivalent product and 

its intended normal and likely accident conditions of use are identical or similar to the 

requested product or can be related (through engineering analysis) to the requested 

product’s conditions of use. In addition, prototype testing of the similar product may also 

be submitted if it can be related to the requested product. The comparison should 

contain information on the similar or equivalent product, including prototype testing, 

applicable engineering analyses, or operational history and a detailed discussion and 

analysis of how this information relates to the requested product. In addition, the 

comparison must demonstrate that the requested product’s ability to operate safely and 

maintain its integrity is equivalent to or more robust than that of the previously approved 

product, or that the differences between the products are such that the integrity and 

safety would not be affected.

Regardless of which approach the applicant chooses to pursue, the reviewer must evaluate 

whether the applicant has adequately demonstrated that the product will maintain its integrity 

during normal use and likely accident conditions, and whether the information adequately 

addresses all concerns about the integrity of the source or device when used in a way the 

applicant has defined as the normal conditions of use.

If the product is registered for use by a custom user, prototype testing may not be required. 

This is typical in a situation in which only a limited number of units will be manufactured, usually 

one or two. Therefore, it may not be feasible to manufacture and test a prototype product that

may not be able to be used after testing. Since only one licensee is using the product, that 

licensee can implement additional administrative controls.
59

10.5.1 Sources

Typically, for sealed sources, the NRC will only accept actual testing of a prototype unit to 

demonstrate integrity. This is because the sealed source is the primary containment of the 

radioactive material. The sealed sources should normally be tested in accordance with 

ANSI N43.6-2007, “Sealed Radioactive Sources, Classification,” or International Organization of 

Standardization (ISO) 2919-1999, “Sealed Radioactive Sources, Classification.” When 

reviewing the testing, the reviewer must evaluate the test methods, procedures, and conditions 

of the tests and acceptance criteria used by the applicant against the standard. Any variations 

must be evaluated.

In addition to testing in accordance with an ANSI or ISO standard, the applicant may need to 

perform additional testing to verify that the source will withstand the conditions of use. For 

example, long sources may need to be subjected to a bend test, and applicants may need to 

verify that a source design will withstand corrosive environments.

Depending on the wall thickness of a source, engraving or etching the labeling information may 

have a detrimental effect on the source integrity. For thin-walled sources, the prototype source 

should include all engraved or etched labeling before testing.

10.5.2 Devices

When evaluating a device, the reviewer must verify that the sealed source incorporated in the 

device has achieved the appropriate ANSI N43.6-2007 or ISO 2919-1999 classification for its 

intended use and is authorized for the activity to be loaded. The registration certificate for the 

sealed source should include its classification.

Devices should be tested in accordance with applicable industry and consensus standards. 

Appendix F to this report lists applicable standards.10 If there is no applicable standard for a 

product, the applicant and reviewer, using professional judgment, need to ensure that the 

testing performed sufficiently simulates the conditions that may be expected during use, 

handling, storage, and transport of the product. The applicant and reviewer may obtain useful 

general guidance from a standard for a comparable source or device.

In addition to the testing recommended in the standards, the applicant and reviewer need to 

consider other potential use and accident conditions that may affect a particular device’s 

integrity. Devices should be tested to demonstrate that they will maintain their containment 

integrity and that the necessary safety features remain operable after being subjected to any 

conditions they are likely to experience.

The testing does not need to verify that a device will operate and perform its intended function 

after being subjected to accident condition testing. However, the product should still ensure that 

the byproduct material is not dispersed, the source capsule remains within the protective source 

housing, and the shielding integrity is not compromised. Typically, an increase in radiation of 

greater than 20% constitutes a compromise of the shielding integrity.

 10 For copies of standards, contact the Health Physics Society, 1313 Dolley Madison Boulevard, Suite 402,

 McLean, VA 22101, telephone: (703) 790-1745, Web site: http://www.hps.org.
60

Occasionally, an applicant may indicate that a product has been tested in accordance with a 

standard that has limited applicability in demonstrating that the product will perform adequately, 

from a radiological standpoint, during normal use and likely accident conditions. Some 

examples of such standards are Type 7A package testing, special form testing for sealed 

sources, and testing to Underwriters Laboratories standards. The reviewer should ensure that 

the applicant does not rely on this testing alone to demonstrate device integrity; for example, 

tests in accordance with 10 CFR 71.75, “Qualification of special form radioactive material,” are 

not sufficient by themselves.

The regulations in table 10.4 below should be referenced for additional information about

prototype testing. Acceptable prototype testing for luminous aircraft safety devices to be used 

under 10 CFR 31.7 and ice detection devices containing strontium-90 for use under 

10 CFR 31.10 are also addressed in NUREG-1556, Volume 16.

Table 10.4: Requirements for Prototype Testing

Regulations

Applicability

10 CFR 32.53(d)(4) and (e) Devices used under the 10 CFR 31.7 general license

10 CFR 32.61(e)(4) and (f) Devices used under the 10 CFR 31.10 general license

10 CFR 34.20 Source and devices designed for use in radiography operations

10 CFR 39.41(a)(3) Sources used in well-logging operations

10 CFR 36.21(a)(5) Sources used in irradiator operations

10.6 Radiation Profiles

The applicant should provide the maximum radiation levels around the product when it contains 

the maximum allowable quantity of each nuclide or combination of nuclides. The applicant 

should include the maximum radiation levels on the surface of the product, at 5 centimeters 

(cm), 30 cm, and 100 cm (2.0 inches (in.), 11.8 in., and 39.4 in.) from the product. The 

applicable standard, ANSI- N43.8-2008 “Classification of Industrial Ionizing Radiation Gauging 

Devices,” does not measure dose rates in the beam—only scatter radiation. Any dose rate 

measurements in the beam path are with the shutter closed. If applicable, the applicant should 

give radiation levels when the device is in the open and closed conditions and when material is 

present in the measuring area. Doses during transient conditions and during other conditions of 

use, such as during calibration, may also need to be reported. The reviewer must verify that the 

applicant has provided the maximum radiation levels.
61

Figure 10.1 Radiation Profiles. Example of ANSI-N43.8-2008, “Classification of 

Industrial Ionizing Radiation Gauging Devices,” isodistance contour.

Figure 10.1 shows an example of an isodistance around a particular gauge configuration.

ANSI N43.8-2008 identifies multiple device types and configurations, and the appropriate 

isodistance contour and setup. When appropriate, the applicant should identify the 

ANSI N43.8-2008 gauge classification.

Measured radiation levels are preferable, but calculated levels also are acceptable. If the 

applicant submits measured radiation levels, the reviewer needs to verify that the conditions 

under which the measurements were taken and the equipment used—including type, window 

thickness, and sensitivity—are acceptable for the nuclide and quantity included in the product. 

If the applicant submits calculated levels, the reviewer needs to verify that the calculations were 

performed in accordance with acceptable methods or standards.

If the applicant takes credit for external shielding or barriers or guards that restrict access to 

higher radiation areas, the radiation levels at, and at distances from, each barrier or guard need 

to be reported.

The reviewer needs to verify that radiation levels are reasonable. The levels for gamma 

emitters should be consistent with the inverse-square law, and levels for non-gamma emitters 

should not. The reviewer also needs to assess whether levels that initially appear unreasonable,

such as higher levels farther from the product, are possible because of scatter.

Even though 50 microsieverts per hour (μSv/hr) (5 millirem per hour (mrem/hr)) at 30.5 cm 

(12 in.) is an industry goal that has been used for many years, in general, there are no 

maximum external radiation level limitations for sealed sources and specifically licensed 

devices. Ultimately, the user is responsible for ensuring that the product is used in accordance 

with 10 CFR Part 20, (e.g., the specific licensee is responsible for ensuring that persons do not 

receive doses in excess of the occupational limits or limits for members of the public and that 

occupational exposures are ALARA).
62

The regulations in table 10.5 below should be referenced for additional information about

radiation profiles and maximum dose commitments.

Table 10.5: Requirements for Radiation Levels

Regulations Applicability

10 CFR 32.22(a)(2)(vi), (xiii), 

and (xiv)

Devices used under the 10 CFR 30.19 exemption

10 CFR 32.26(b)(6), (13), and 

(14)

Devices used under the 10 CFR 30.20 exemption

32.30(b)(6) Devices used under the 10 CFR 30.22 exemption

10 CFR 32.51(a)(2)(ii) and (iii) Devices used under the 10 CFR 31.5 general license

10 CFR 34.20 and 

10 CFR 34.21

Source and devices designed for use in radiography 

operations

10.7 Quality Assurance and Quality Control

The applicant must provide details of the QA program that will be implemented to ensure that 

the product is manufactured and distributed in accordance with the representations made in the 

application and with the statements contained in the registration certificate for the product. At a 

minimum, the QA program needs to ensure that (1) the materials of construction and the final 

assembly meet the design specifications, (2) the final product is leak tested, (3) a final radiation 

profile is performed, (4) a test is performed that verifies that the product operates as intended, 

including all safety functions, and (5) a visual and mechanical inspection is performed of 

components that are considered related to safety or are expected to be susceptible to failure 

under extreme or unusual conditions. Some of these inspections may be performed on a 

sample basis. The reviewer must verify that the applicant has provided adequate information 

concerning the QA program.

The QA program provides control over all activities applicable to the design, fabrication, 

inspection, testing, maintenance, repair, modification, and distribution of the sealed sources or 

devices. This puts more emphasis on the overall management structure and on the program 

that covers construction of the device from the time of initial design through refurbishment. 

To evaluate the adequacy of the QA program, the reviewer may use the checklist in Appendix G 

to this report or other generally accepted guidance.

The NRC staff may consider a QA program that is part of a QA program designed and intended 

to meet another established standard or requirement, including programs established to meet 

ISO or ANSI QA program standards, military QA standards, or requirements or regulations 

established by other U.S. Government agencies (such as FDA).

Sealed source and device vendors frequently use and are accredited in accordance with the 

international/U.S. QA standard ANSI/ISO/American Society for Quality (ASQ) 9001-2000, 

“Quality Management Systems—Requirements”.The NRC documented its position on the 

international quality standards in SECY-03-0117, “Approaches for Adopting More Widely 

Accepted International Quality Standards,” dated July 9, 2003. The paper primarily addresses 
63

the applicability of international quality standards to safety-related items of commercial nuclear 

power plants. However, the conclusions are also applicable for sealed sources and devices.

If the vendor of sealed sources and devices is accredited to the current standard, the SSD 

reviewer may accept the certificate of accreditation in lieu of a full set of QA/QC plans or 

procedures. However, the vendor must make the commitment that the generic QA/QC program 

includes additional provisions that address the specific issues involved in the fabrication of 

sealed sources and devices, such as the following:

• There is full design conformity in accordance with the statements and commitments 

submitted in support of the application (including materials of construction, dimensions 

within stated tolerances, manufacturing methods, assembly methods, labeling). All units 

are leak tested to 185 Bq (0.005 μCi).

• All units are tested for proper operation of all safety features.

• All units are verified that the radiation levels do not exceed the maximum values stated 

in the application.

If the product is registered for use by a custom user, submission of a complete QA program may 

not be required. This is typical in a situation where only a limited number of units will be 

manufactured, usually one or two. Because the purpose of a QA program is to ensure that all 

devices are manufactured to the same specifications, the development and submission of a 

complete program may not be feasible. Since only one licensee is using the product, that 

licensee can implement additional administrative controls.

If a vendor is a foreign manufacturer with an affiliate distributor in the United States, the 

distributor is responsible for assessing the vendor’s QA/QC program performance in 

accordance with the vendor’s established procedures, accepted standards, or guides. The 

distributor must have an established program for assessing the manufacturer’s QA/QC program. 

This includes an evaluation of the foreign manufacturer’s performance in accordance with these 

standards at a frequency necessary to ensure that QA is met. The distributor also must 

maintain records of such audits for future regulatory review.

Specifically, in cases involving foreign manufacturers, the QA/QC functions for fabrication are to 

be performed at the foreign facility, and the U.S. distributor periodically must audit the foreign 

facility. Copies of all records must be maintained in the United States as specified by the 

provisions of 10 CFR 110.53(b). With every lot of the product, the foreign manufacturer must 

forward to the U.S. distributor (1) the leak test results and (2) copies of documents certifying that 

the QA/QC commitments made in the application have been met. The U.S. distributor must 

review and approve the records before the release of the lot. Other QA/QC records must be 

forwarded to the U.S. location on a periodic basis and must be available upon request in a 

reasonable time. This policy does not exempt the U.S. distributor from ensuring that all QA/QC 

functions are performed and from being responsible for ensuring that the product is distributed

in accordance with all statements and commitments made in the application and the registration 

certificate. The SSD reviewer must review and accept the QA/QC plan and procedures at the 

same level or detail as if the product were manufactured at a U.S. facility.

The reviewer is not responsible for establishing a frequency for QA program audits by the 

regulatory agency issuing the registry. Audits of the QA program by regulatory agencies do not 

need to occur on a routine basis, but they may occur if trends indicate generic failures of a 
64

product. The applicant should include third-party audits by an unbiased entity as an integral 

part of the QA program. 

FDA approves devices for medical use before NRC device evaluation and registration. FDA 

requires domestic or foreign manufacturers to have a quality system for the design and 

production of medical devices intended for commercial distribution in the United States. 

Manufacturers must comply with the Good Manufacturing Practices requirements in 

21 CFR Part 820, “Quality System Regulation,” which covers all aspects of quality management. 

FDA’s Good Manufacturing Practices requirements are extensive and similar to those of the 

NRC; therefore, QA programs do not need to be submitted or reviewed for FDA-approved 

sealed sources or devices. An applicant should provide documented proof that FDA has 

approved the sealed source or device and that the applicant maintains an FDA-approved QA 

program. Section 4.10, “Sealed Sources and Devices for Medical Use,” discusses types of 

FDA product approvals.

The regulations in table 10.6 below should be referenced for additional information about QA

and QC. Acceptable sampling procedures (QC) for luminous aircraft safety devices to be used 

under 10 CFR 31.7 and ice detection devices containing strontium-90 for use under 

10 CFR 31.10 are also addressed in NUREG-1556, Volume 16.

Table 10.6: Requirements for Quality Assurance and Quality Control

Regulations Applicability

10 CFR 32.55 Devices used under the 10 CFR 31.7 general license

10 CFR 32.61(e)(5), 10 CFR 32.62 Devices used under the 10 CFR 31.10 general license

10 CFR 32.22(a)(2)(xv), 10 CFR 

32.25(a)

Self-luminous products (10 CFR 30.19)

10 CFR 32.26(b)(15), 10 CFR 

32.29(a)

Gas and aerosol detectors (10 CFR 30.20)

10 CFR 32.30(b)(15) Certain industrial devices (10 CFR 30.22)

10 CFR 32.51(a)(2) Certain generally licensed items devices (10 CFR 

31.5)items

10 CFR 32.53(b)(5), 10 CFR 

32.55)))

Luminous devices for aircraft (10 CFR 31.7)

10 CFR 32.61(b)(5) and (e)(5), 10 

CFR 32.62

Strontium-90 ice detectors (10 CFR 31.10)

10 CFR 32.74(a)(2)(v) Medical equipment (10 CFR Part 35)

10 CFR 32.210(c) All Sealed sources and devices
65

10.8 Installation, Servicing, and Instructions to Users

The applicant should provide any special procedures that need to be followed when the product 

is installed at the user’s facility. These include mounting; installing interlocks, guards or 

barriers; and determining whether a specific licensee needs to perform the installation. General 

licensees may be permitted to mount products, depending on their design.

An applicant may request that general and specific licensees, without specific authorization 

under that license, be permitted to mount products. In order for the NRC to grant such a 

request, the applicant must provide justification for approval (e.g., likely doses to persons 

mounting the device, why specific training is not necessary to perform mounting) and must 

provide written procedures that must be followed to mount the product safely. The reviewer 

must evaluate the adequacy of the procedures. These procedures must indicate the following:

• The product must be mounted in a location compatible with the “Conditions of Normal 

Use” and “Limitations and/or Other Considerations of Use” on the registration certificate.

• The on/off mechanism (shutter) must be locked in the off position, if applicable, or the 

source must be otherwise fully shielded.

• The product must be received in good condition (i.e., package is not damaged).

• The product must not require any modification to fit in the proposed location.

The “Limitations and/or Other Considerations of Use” section of the registration certificate must 

specifically state whether or not general or specific licensees may initially mount the product, in 

accordance with the manufacturer’s instructions, or any mounting after moving.

In addition, the applicant should indicate if a specific licensee could only perform other services 

necessary to support safe use of the products or if a general licensee could also perform them. 

These include calibration, relocation, leak testing, routine maintenance, radiation surveys, 

training for users, changing of sources, and final disposal of the byproduct material. The 

applicant needs to indicate whether the applicant, or the manufacturer or distributor, will provide 

the necessary services or identify an entity that will provide such services. If the applicant 

cannot identify an entity that will provide the necessary services, the registration certificate 

should include this in a reviewer note. However, if the device is to be possessed and used by a 

general licensee, and the applicant cannot identify an entity that will provide services that 

cannot be performed by the generally licensed users, the device should not be registered. 

Reviewers should recognize that vendors or service companies may discontinue providing 

services. The NRC is typically notified when a vendor decides no longer provide services.

Registration certificate holders requesting to transfer a registration certificate to inactive status 

should identify whether they plan to continue to provide services for the registered products or 

whether they are aware of an entity that will provide services (see Section 13.4, “Transfers to 

Inactive Status.”) The reviewer needs to verify that procedures for servicing the product are 

adequate, can be performed by the persons indicated by the applicant (e.g., by a general 

licensee), and do not interfere with, or compromise, the integrity of the product. As indicated in 

Chapter 6, “How to File,” the applicant should submit a copy of the user operating manual and 

safety instructions. . In accordance with 10 CFR 32.210(c), these documents should provide 

the end user with “sufficient information about installation, service and maintenance, operating 

and safety instructions, and its potential hazards, to provide reasonable assurance that the 
66

radiation safety properties of the source or device are adequate to protect health and minimize 

danger to life and property 

The reviewer must verify that the applicant provides the user of the product with the information 

necessary to safely operate and maintain the product. Such information should include

instructions for operation, maintenance, calibration, damage/failure, specific warnings, leak 

tests, and radiation surveys. 

The applicant also should provide information to the user about who may provide services for 

the product. For devices distributed to general licensees, the applicant must provide specific 

information as required under 10 CFR 32.51a. To assist the reviewer in determining whether 

general licensees may perform certain activities, the applicant must provide an estimate of the 

dose to a worker for each activity to be performed.

For medical use, 10 CFR 35.67(a) states, “A licensee in possession of any sealed source or 

brachytherapy source shall follow the radiation safety and handling instructions supplied by the 

manufacturer.” Therefore, the reviewer needs to verify that these instructions are complete and 

encompass likely incident or accident conditions. 

The reviewer needs to verify that the documentation provided to users of the products does not 

misinterpret, misrepresent, or lead the user into violating any applicable regulations.

Figure 10.2 Installation and Servicing of Devices. Applicants must specify the 

qualifications needed by individuals to perform installation and servicing of 

devices.

The regulations in table 10.7 below should be referenced for additional information about

servicing.
67

Table 10.7: Requirements for Servicing of Devices

Regulations Applicability

10 CFR 32.51(b) and (c) Devices used under the 10 CFR 31.5 general license

10 CFR 35.605 Installation, maintenance, adjustment, and repair of remote 

afterloaders, teletherapy units, or gamma stereotactic 

radiosurgery units

10 CFR 35.655 5-year inspection for teletherapy and gamma stereotactic 

radiosurgery units

10.9 Safety Evaluation and Concurrence

Concurrence review includes an independent technical review of the materials submitted by the 

applicant and the documents generated by the initial reviewer. The concurrence review 

includes evaluation of each area addressed during the initial review (e.g., construction of the 

product, labeling, and prototype testing), but the concurrence review is not to the same level of 

detail as the initial review. The concurrence review should focus on ensuring that the product 

meets all applicable regulations, that the product would not pose any health or safety concerns, 

and that the registration certification provides an adequate basis for licensing. This concurrence 

review by a second qualified reviewer is necessary in view of the potential health and safety 

implications resulting from the widespread distribution of sealed sources and devices.

69

11. DEFICIENCIES IN THE APPLICATIONS

In the process of evaluating an application, a reviewer may determine that the applicant has 

submitted insufficient information. If this is the case, the reviewer must contact the applicant to 

obtain the information. Depending on the type of information needed, the reviewer may obtain 

the information by sending a formal written request to the applicant, request a meeting with the 

applicant, notify the applicant of the need for information via telephone or electronic mail, or 

obtain the information directly from the applicant during a telephone conversation or via 

electronic mail.

Because of the need to complete the application reviews in a timely manner, the reviewer 

should perform the actions described in the sections below when addressing deficiencies in 

applications.

Additional information regarding deficiencies is available in NUREG-1556, Volume 20.

11.1 Sending Deficiency Letters to Applicants

Any significant or complex deficiencies in an application for an evaluation must be set forth in a 

formal deficiency letter to the applicant. The letter should request that the response be provided 

in duplicate. The letter to the applicant should request that the applicant respond within a 

specified number of days from the date of the deficiency letter. The number of days is typically 

30 to 60 days, but this depends on the complexity of the information and the level of effort 

needed by the applicant to respond (e.g., extra time may be needed to perform prototype testing 

on a product). In addition, the letter should indicate that if the NRC does not receive a written 

response11 to the deficiency letter within the number of days specified in the letter, the reviewer 

will consider the application as “abandoned” for failure to provide the requested information,

“without prejudice” to the resubmission of a complete application., and “close” the application.

12

The reviewer should take prompt action (i.e., within 5 working days) to close the application 

after the application has been considered abandoned. The reviewer should notify the applicant, 

in writing, that the application has been considered abandoned and the reviewer will close the 

review. 

If the NRC receives a response to the deficiency letter after the application has been closed, but 

less than 1 year from the date of the letter, the application should be assigned a new tracking 

number and handled as a new application; however, no additional fee may be necessary if the 

response only requires a continuation of the evaluation. The agency will not assign a higher

priority to the application solely based on the fact that it is a resubmission.

 11 A written response may be by letter, e-mail, or fax from the applicant.

12 The terms “abandoned,” “without prejudice,” and “close” are not meant to have legal connotations.

 As used in this report, “abandoned “Abandoned” means that the applicant for a new license or for an

 amendment to an existing license has given up its pursuit of the license or amendment, “without. 

 “Without prejudice” means that the applicant can resurrect its application within some reasonable

 time without having to pay another fee or having its application redocketed, and “close. “Close”

 means that the application is no longer under consideration.
70

11.2 Meeting with Applicants

Either the NRC or applicants may request meetings to discuss sealed source and device 

applications. The meetings may take place before submission of an application, or after

submission to discuss items included in a deficiency letter. Meetings between the NRC and 

applicants may occur at an NRC office or at the applicant’s facility if it is determined that a 

meeting would enhance the NRC’s understanding of the product.

11.3 Using the Telephone or Electronic Mail To Obtain Additional Information

Reviewers may use the telephone or electronic mail to obtain clarifying information from an 

applicant. To accelerate the review process, the NRC may use these mechanisms to notify an 

applicant of simple deficiencies.

However, use of the telephone or electronic mail to notify an applicant of deficiencies must be 

limited to items that are simple and that can be explained in simple terms. Such items include a 

request for the model number of a sealed source, the need for an applicant commitment to 

perform a procedure, or the clarification of a material type or a dimension.

If the deficiency requires a clarification of information provided in the application, it may not be 

necessary to have the applicant respond in writing. This decision is left to the discretion of the 

reviewer. However, the applicant’s response, whether via the telephone or electronic mail, must 

be documented and included as part of the application.

In all cases, the person initiating the communication must document the telephone conversation 

or electronic mail transmitting deficiencies to an applicant. If the applicant does not respond to 

the issues discussed within 15 calendar days, a reminder letter must be sent to the applicant. 

The reminder letter is a letter that clearly specify the deficiencies and must be handled as a 

typical deficiency letter, with the exception that it includes a statement that the information 

needs to be received within a specified timeframe or the application will be closed.

11.4 Requesting Response Time Extensions

The NRC may grant a request from an applicant for an extension of time to respond to any 

correspondence about its application if the agency determines that there is good cause to grant 

an extension. The request may be in writing, via the telephone or e-mail. Typically, the

reviewer should respond by telephone to notify the applicant that an extension has been 

granted. All requests for extensions must be approved by NRC management and must be 

documented in a conversation record.
71

12. CONTENTS OF THE CERTIFICATE

Registration certificates are written in a standard format. This allows license reviewers and 

inspectors to quickly retrieve the information necessary to perform a license review, perform a 

site inspection, or respond to incidents involving lost, damaged, and/or abandoned sealed 

sources or devices.

The registration certificate is a summary of the technical evaluation of the product. It contains 

summaries of the areas examined during the evaluation process. Appendix D to this report

includes standard formats for registration certificates for a sealed source, for a device, and for 

an exempt device. This chapter provides further clarification of the information included in a 

registration certificate.

12.1 Header

The header includes the title of the document, the registration number, date of issuance, page 

numbering, and the sealed source or device type. If the certificate is amended or corrected, this 

is indicated in the title; the page number of each corrected page(s) is listed or the header notes 

that the certificate is amended in its entirety. The reviewer assigns the registration number, in 

accordance with the numbering procedures in Appendix B. The issue date is the date the 

certificate has received both reviewer and concurrence signatures.

12.2 First Page Information

The first page of each certificate includes the model number of the sealed source or device, the

name and complete address of the manufacturer and distributor, the manufacturer or distributor 

and model number for the sealed source incorporated in the device (for devices), isotopes, 

maximum allowable activity levels, leak test frequency, principal uses (including code and 

description), and an indication of whether the registered product is designed for custom use. If 

registered for custom use, the name and address of the custom user are included. This 

information is entered into the NRC-maintained, computerized NSSDR.

For clarity, there should be only one maximum activity listed for each radionuclide. If there are 

multiple activity limits or configurations within a family or series of sources or devices, the 

description section should include the model-specific values. 

The following sections describe, in order, the information included in the rest of the certificate for 

sources and devices, beginning with the second page.

12.3 Description

This section provides a narrative description of the construction of the product, the safety 

features of the product, and ON/OFF and safety indicators. The description should include the 

materials of construction and fabrication techniques for safety-related components of the 

product (e.g., source encapsulation materials, source holder materials, shutter mechanisms, 

welding process, and device safety related features, such as tamper-resistant fasteners and

locks). The description also includes overall dimensions of the sealed source and the device.
72

Certificates for sealed sources include the chemical and physical forms of the source material. 

Certificates for devices describe how the sealed source is secured within the device and how 

the product is protected from its intended environment (e.g., hermetically sealed, fireproof, 

corrosion resistant).

The revision history for amended registration certificates could also be included in the 

registration certificate for license reviewers and inspectors. Only the most recent registration 

certificate is kept on file. A revision history could help license reviewers and inspectors to be 

aware of changes over time for older devices still in use. 

The text may be structured in a format that enhances clarity (e.g., with subheadings).

12.4 Labeling

This section describes how the labeling requirements are fulfilled. It lists the information 

contained on the label, construction of the label, and how and where the labeling is attached to 

the product. Any exemptions from labeling requirements or omissions of information typically 

included on the labels will be noted. A visual representation of the label may be included as an 

attachment.

12.5 Diagrams

This section lists the diagrams, drawings, sketches, or pictures of the product that are included 

in the certificate. These are typically included as attachments to the certificate and should 

include the overall dimensions of the product, the location of the sealed source within the 

device, and the safety-related features of the product. A person using the certificate, such as an 

inspector or license reviewer, should be able to identify a device given the diagrams and the 

description from the certificate.

12.6 Conditions of Normal Use

This section lists the environmental conditions the product is intended to withstand. It also 

includes the normal intended uses of the product and any limitations that define these uses. 

The working life also may be included.

12.7 Prototype Testing

This section describes tests performed on prototypes of the product to demonstrate product 

integrity when subjected to conditions of normal use and likely accident conditions. If the 

product was tested in accordance with an applicable industry or consensus standard, this 

section should state the corresponding classification, as defined by the standard. If the product 

was tested in accordance with an applicable regulation, this section specifies whether the 

product satisfactorily met the requirements of the regulation.
73

If, in lieu of prototype testing a product, an applicant submitted operational history of the product

or a similar product or provided an engineering analysis that demonstrates that the product is

adequately designed, this section will provide the details of the operational history or

engineering analysis and the basis for determining the design to be adequate.

12.8 External Radiation Levels

This section states the maximum radiation levels from the product when loaded with the 

maximum activity of each nuclide or combination of nuclides. If the manufacturer is unable to 

provide measured external radiation levels for the product, the certificate lists a conservatively 

calculated maximum radiation profile. If applicable, the radiation profiles are listed for shutter 

open and closed conditions. The stated levels are the maximum radiation levels expected from 

the product and take into consideration factors affecting the levels, such as whether the product 

is present in the measuring area or whether certain areas around the device are restricted from 

access. Any significant contaminants that would change the expected radiation levels are 

stated. Ideally, the radiation levels listed in this section will include the levels on contact with the 

product, at 5 cm, 30 cm, and 100 cm (2 in., 12 in., and 39 in.) from the product, and in the 

beam.

Should a device contain a number of isotopes and be designed with a range of dimensions, a 

distributor may commit to ensuring that the radiation levels do not exceed a specified level. If 

this is the situation, the certificate needs to include the maximum allowable radiation level and 

state limitations on the installation of the device.

For devices, the certificate includes the ANSI N43.8-2008 classification, if available and not 

included in a prior section. 

12.9 Quality Assurance and Quality Control

This section includes a summary of the QA measures that will be followed to ensure that the 

product meets all applicable specifications. If the QC procedures meet a national or industry 

standard or regulation or FDA’s Good Manufacturing Practices, this fact is specified in this 

section. If the applicant commits to following a complete QA/QC program, this section may 

include a short summary of the program and reference that details of the complete program are 

on file with the NRC. The section also contains a statement reflecting that the NRC has 

assessed the QA/QC program and deemed it acceptable.

12.10 Limitations and Other Considerations of Use

This section establishes the safety-related limiting conditions imposed on the sealed source or 

device not already addressed by existing regulations. These may include leak testing, shutter 

test frequency, special handling, storage or use considerations, environmental conditions, 

labeling, special handling procedures and tools, and specific licensing conditions that should be 

addressed by the license reviewer. This section needs to clearly indicate the services that may 

be performed by general-licensed users of the products. It also includes a limitation that 
74

states that the registration certificate and the information contained within the references shall 

not be changed without the written authorization of the NRC. Limitations on sealed sources and 

devices can be divided into two categories: (1) limitations placed on the manufacturer or 

distributor of the sealed source or device and (2) limitations placed on the user of the sealed 

source or device. Limitations in the first category are derived from regulations. The second 

category of limitations is derived from both regulations and conditions imposed by the 

manufacturer, particular conditions of use that would reduce the radiation safety of the device, 

and circumstances unique to the sealed source or device that require that the sealed source or 

device receive a special limitation.

In addition, this section of the certificate may contain reviewer notes. The purpose of such 

notes is to identify to license reviewers areas of use of the product that cannot be controlled as

part of the registration. This alerts the license reviewer to verify that the licensee implements 

certain administrative procedures before initial use, as part of routine use, or as part of an 

emergency response to an incident. For example, indicating in a reviewer note that a vendor no 

longer offers servicing for the product alerts the license reviewer to obtain more than a 

statement that the vendor will provide services.

12.11 Food and Drug Administration Approval Summary

This section contains FDA information for sealed sources and devices used for medical use. 

Reviewers do not evaluate the data provided by the applicant. The references provided by the 

applicant are for information only. Applicants provide proof of FDA approval type and specific 

use limitations that are not evaluated by the NRC or Agreement States but that are important for 

users to know.

12.12 Safety Analysis Summary

This section summarizes the conclusion of the evaluation performed by the reviewer and states 

that the product is acceptable for certain licensing conditions. This section also typically lists

any additional features that the device, surroundings, environment, or accessories may 

contribute to the integrity or safety of the product. These may include physical constraints such 

as barriers, fences, or guards and actual use time in terms of radiation exposure resulting from 

working around the product.

12.13 References

This section incorporates by reference the documents that were submitted in support of the 

application. These references include applications, letters, faxes, electronic mail messages, 

and enclosures to such documents. The applicant is required to adhere to the information and 

commitments included in these references and to retain the references in accordance with 

applicable records retention requirements.

12.14 Issuing Agency

This section identifies the NRC as the regulatory agency that issued the certificate and includes 

the date issued and the typed names and signatures of the two persons who reviewed the 

certificate and all applicable documentation. All certificates include two signatures as part of the 

QC measures.
75

12.15 Attachments

This section typically contains diagrams, drawings, sketches, or pictures of the product, as 

discussed in Section 12.5, “Diagrams.” These enable inspectors to easily identify the devices in 

the field. The attachments also may contain designations of specific models and their 

characteristics, such as dimensions and sealed source activities, if a series of devices is 

registered.

The header for the attachments is similar to that for the main body of the registration certificate. 

The header contains the title of the document, registration number, date of issuance, and 

attachment numbering. The header does not contain the sealed source or device type.

12.16 Dimensions and Use of Dual Units

The NRC’s previous metrication policy (SECY-96-098, “Final Policy Statement—Conversion to 

the Metric System,” dated May 7, 1996) provided that documents specific to a registration 

certificate holder, such as the registration certificate, include dimensions in the units employed 

by the registration certificate holder. For example if the application used English units, then the 

registration certificate would also contain the same units.

Guidance on the use of units appears in NUREG-1379, Revision 2, “NRC Editorial Style Guide,”

issued May 2009. 

77

13. MODIFICATIONS TO EXISTING REGISTRATION CERTIFICATES

It is the obligation of the registration certificate holder to keep the registration certificate current. 

If a registration certificate holder plans to make a change to the registered product that affects 

the commitments made in the information provided in support of the application or the 

conditions included in the registration certificate, the registration certificate holder must file for 

an amendment or correction to the registration certificate. Until the amendment request is 

approved and the amended certificate is issued, the registration certificate holder is obliged to 

comply with the information in the certificate. Registration certificate holders are encouraged to 

anticipate the need for certificate amendments as far in advance as possible.

The registration certificate holder should retain one copy for its records and submit the original 

certificate to the address specified in Chapter 7, “Where to File.” The application should identify 

the registration certificate by number and should clearly describe the changes and the effects of 

the changes on the safety properties of the product. References to previously submitted 

information should be clear and specific and should identify that information by date, document 

title, and page number.

An application to amend a certificate should be accompanied by the appropriate fee if applicable 

(see 10 CFR 170.31 for current requirements and Chapter 8, “Registration Fee,” of this report 

for specific guidance). For medical products, the registration certificate holder must have 

obtained FDA approval before submitting a request for amendment to the registration certificate.

The request for an amendment or correction needs to address the changes to the product and 

how the changes affect the original safety evaluation of the product. The reviewer needs to 

evaluate the changes to determine whether they have any adverse effects on the safety of the 

product and whether the initial evaluation and the determination of adequacy are still valid. The 

reviewer needs to look at all aspects of the initial evaluation to determine whether the change 

would have an effect on another aspect of the evaluation that may not be readily evident. For 

example, changing a part of the source holder from stainless steel to lead may improve the 

shielding efficiency, but it may have detrimental effects on how the device will react to accident 

conditions. The manufacturer may have overlooked this type of detrimental effect.

13.1 Amendments

If the registration certificate holder requests an amendment to the certificate (i.e., it requires a 

safety evaluation to be performed), the certificate should be amended in its entirety. The 

certificate header should include, under the title, the following:

(AMENDED IN ITS ENTIRETY)

An amended certificate should be issued when new information is added to the certification file, 

such as name or address changes. Once the new information is added to the registration, the 

correspondence should also be added as a reference to the signature page. All pages of the 

certificate must show the new date of the amendment. 

The certificate should be assigned a new issue date, and the certificate should be reissued in its 

entirety. When appropriate, the reviewer should use bold typeface to highlight the changes to 

the certificate. In addition, if products that meet the previous design specifications remain in 

use, reviewers must ensure that previous design information stays in the registration certificate 
78

and must delete sections that are no longer applicable. The reviewer should describe the 

changes and the effective date of the change in the description section for historical continuity. 

The registration certificate also should identify, by date or serial number, when a design change 

is implemented.

13.2 Corrections

If the change only involves corrections to the certificate (i.e., does not require a safety 

evaluation to be performed), such as adding or clarifying information when such information was 

already part of the certificate file, or correction of a typographical error identified in the 

certificate, then only the affected pages of the certificate need to be updated and issued. The 

corrected page should show the date of the certificate as it was before and also include the date 

of correction. The reviewer should use bold typeface to make the corrections. Each affected 

page should include, in the header, under the title, the words “CORRECTED PAGES,” the 

number of each page affected, and the date of the correction, as shown below:

(CORRECTED PAGES 1, 2, & 4—JULY 5, 2000)

The issue date of the certificate should remain the same as the last issue date. It is not 

necessary to include the letter from the registration certificate holder requesting the correction in 

the reference section of the certificate.

However, if the correction requires a change to the signature page of the certificate, the 

certificate should be amended in its entirety. The reviewer may elect to postpone making 

corrections to the signature page until the registration certificate holder requests an amendment

to the certificate, thus requiring a safety evaluation.

13.3 Combining Registration Certificates

Registration certificate holders may ask the NRC to combine two or more certificates into a 

single certificate. However, it is NRC policy that a single registration certificate may group 

together only products that are essentially identical in design, function, and construction and 

that vary only in a dimensional capacity, in the sources used, or in their application.

Combining registration certificates does not require a safety evaluation. However, the reviewer 

must determine whether the request meets the MSSA policy and whether the registration 

certificates can be administratively combined.

13.4 Transfers to Inactive Status

A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) 

or device(s) covered by a particular certificate shall request inactivation of the registration 

certificate. A request for inactivation of a registration certificate must be made when the 

distributor has no ongoing intent to distribute the device; i.e., when: (1) there is no ongoing 

intent to distribute a product and (2) two years have passed since distribution has ceased.
79

If a registration certificate holder asks the NRC to transfer a registration certificate to inactive 

status,13 the registration certificate holder should provide the following:

• the total number of the products sold and the number of products still in use14

• the services (including source replacement and availability) the registration certificate 

holder will still provide to users of the product or the identification of an entity that will 

provide services. Servicing of devices must be in accordance with all the conditions in 

the certificate

• a commitment that the registration certificate holder will no longer commercially 

distribute the product

• verification that no changes were made to the product since its initial registration or last 

amendment. If changes have been made, then the new information must be 

incorporated into the inactivated certificate. However, the changes need not be in a bold 

typeface because the certificate has a new registration number assigned to it

• the associated specific license number if a distribution license is terminated in 

accordance with 10 CFR 30.36, “Expiration and termination of licenses and 

decommissioning of sites and separate buildings or outdoor areas”

The reviewer should verify that the request for inactivation includes the information noted above

and that the background file for the product evaluation is complete and accurate. Because 

some registrations were issued many years ago, the files may not include all the information 

that is now needed. Therefore, the reviewer should request that the registration certificate 

holder submit any and all additional information that would be needed to make a determination 

that the product is acceptable for licensing purposes. The reviewer should make the reference 

file as complete as possible.

The reviewer needs to write an updated registration certificate, including the new registration 

number (see Appendix B for instructions on issuance of inactive registration certificate numbers) 

and updated information. Directly under the new registration number, the reviewer should insert 

a reference to the old registration number with the statement “Supersedes NR-XXXX-D-YYY-S.” 

The reviewer may also refer to the previous registration for clarity or for historical documentation 

in the text of the registration certificate; for example, the reviewer may place such a reference 

as a “Reviewer’s Note” in the “Limitations and/or Other Considerations of Use” section of the 

registration certificate. The new certificate will contain a statement that the product will no 

longer be commercially distributed but may still be approved for licensing purposes. The new 

registration certificate will replace the old registration certificate and will be used as the basis for 

continued licensing of the product.

Some registrations contain a series of sources or devices on a single certificate, some of which 

are being inactivated and others not. In these cases, the existing certificate may be amended 

 13 The NRC also will transfer a registration certificate to inactive status if it knows that the registration certificate

 holder is out of business (see Section 5.9).

14 If the registration certificate holder does not know the actual number of products sold and still in use, it should

 provide a best estimate.
80

by extracting the inactivated models. An inactive certificate containing these models may then 

be 

created. In such cases, the inactive certificate should reference the original certificate where 

the active models remain registered. The amended original certificate must contain updated 

information on the models that are still active and should reference the inactive certificate for 

those models that have been inactivated.

Licensees with custom sealed sources and devices should inactivate the custom registration 

when sources or devices are permanently disposed of, placed in permanent storage, or 

transferred to another licensee that has obtained its own custom registration or that has

broad-scope authorization. The licensee should verify the number of sealed sources or devices 

disposed of, placed in permanent storage, or transferred to another licensee and confirm that no 

changes have been made to the custom product since its initial registration or last amendment.

13.5 Reactivating Inactive Registration Certificates

Vendors may submit requests to reactivate inactive registration certificates. The NRC handles 

requests to reactivate inactive registration certificates using one of three methods:

(1) If the background information on file with the NRC for the inactive registration certificate 

is complete and up to date, and the vendor does not request any changes to the 

information, the vendor may simply submit a letter to the NRC requesting reactivation of 

the registration certificate. The letter should include commitments that the information 

on file with the NRC is complete and accurate and that the vendor will abide by all 

information on file with the NRC. The reviewer must verify that the information is 

complete before assigning a new registration certificate number and reissuing the 

certificate.

(2) If the background information on file with the NRC for the inactive registration certificate 

is incomplete or not up to date, or the vendor requests changes to the information 

(e.g., changes in the design of the product or manufacturing or distribution procedures), 

the vendor should submit a complete application for evaluation and registration in 

accordance with the guidance provided in this document. The reviewer must review and 

evaluate the application in the same manner as a new application.

Directly under the new registration number, the reviewer should insert a reference to the old 

registration number with a statement, “Supersedes NR-XXXX-D-YYY-S.” The reviewer may 

also refer to the previous registration for clarity or for historical documentation in the text of the 

registration certificate; for example, the reviewer may place such a reference as a “Reviewer’s 

Note” in the “Limitations and/or Other Considerations of Use” section of the registration 

certificate.
81

13.6 Ownership Changes and Corporate Relocations

If a registration certificate holder asks the NRC to transfer a registration certificate because of

ownership changes or corporate relocations, the registration certificate holder should perform 

the following:

• Delineate the facility’s name and location where the products are manufactured.

• Specify the serial number of the last unit that was distributed by the old company before

the name or address change, and the number of completed units that were transferred 

by the old company to be distributed by the new company.

• Provide change of ownership information discussing the transfer of products, records 

custody, and servicing arrangements for products previously distributed.

• Provide a new label for the devices indicating the new company name and the effective 

date of the label change.

• Confirm that no changes were made to the product since its initial registration or last 

amendment.

• Verify that previous commitments made by the old company have not changed.

• Provide details about the QA program under the new ownership or at the new location.

The reviewer should assign a new vendor code when ownership changes. When a product 

registration is taken over by another vendor, the reviewer should change the registration 

number to the new vendor and its next sequential unit number (see Appendix B to this report).

83

14. IDENTIFYING AND REPORTING DEFECTS AND 

NONCOMPLIANCE AS REQUIRED BY 10 CFR PART 21

Registration certificate holders must adopt appropriate procedures to evaluate deviations in 

product designs or failures to comply with registration requirements to identify defects or failures 

to comply that are associated with a substantial safety hazard. A substantial safety hazard is 

defined in 10 CFR Part 21, “Reporting of Defects and Noncompliance,” as a loss of safety 

function to the extent that there is a major reduction in the degree of protection provided to 

public health and safety for any facility or activity licensed, other than for export, pursuant to 

10 CFR Parts 30, 40, 50, 60, 61, 70, 71, or 72. However, NRC Information Notice 91-39, 

“Compliance with 10 CFR Part 21, ‘Reporting of Defects and Noncompliance,’” dated 

June 7, 1991, which can be found on the NRC’s Generic Communications webpage under 

Information Notices: http://www.nrc.gov/reading-rm/doc-collections/gen-comm/.indicates that 

from a radiological perspective, a substantial radiation safety hazard exists if there is a potential 

for a moderate exposure to, or release of, licensed material. Further, it provides the following 

for determining moderate exposure or release of licensed material:

• Guidelines for determining moderate exposure:

– greater than 250 mSv (25 rem) exposure (whole body or its equivalent to other 

body parts) to occupationally exposed workers in a period of a year or less

– greater than 5 mSv (0.5 rem) exposure (whole body or its equivalent to other 

body parts) to an individual in an unrestricted area in a period of a year or less

• Guidelines for determining the potential for release of licensed material:

– release of materials in amounts reportable under the provisions of 

10 CFR 20.2202(b)(2)

All defects or failures to comply that are associated with, or could lead to, a substantial safety 

hazard must be reported to the NRC pursuant to 10 CFR 21.21. In addition, registration 

certificate holders must meet the posting requirements specified in 10 CFR 21.6, “Posting 

requirements.”

Applicants need not submit copies of the procedures that are necessary to meet the 

requirements of 10 CFR Part 21. However, applicants should be aware of the need for such 

procedures, and the NRC will evaluate the procedures during inspections. If a certificate holder 

identifies a 10 CFR Part 21 defect that results in a design change, an amendment to the registry 

must be made.

85

15. GLOSSARY

Active Registration Certificate means a registration certificate for a sealed source or device 

that may be authorized for initial distribution. It constitutes part of the basis for the NRC and 

Agreement States to issue licenses.

Active Vendor means a vendor, listed on a registration certificate, that may be authorized to 

initially distribute the sealed source or device listed on the registration certificate.

Agreement State means a State that has entered into an agreement with the NRC allowing the 

State to regulate the use of byproduct material within the State. FSME can provide a complete 

listing of the current Agreement States, including addresses and points of contacts.

Agreement State Registration Certificate means a registration certificate, issued and 

maintained by an Agreement State, for a sealed source or device evaluated by the Agreement 

State.

Applicant means a vendor or custom user of a product that applies for a certificate of 

registration with the NRC or an Agreement State. The applicant is responsible for ensuring that

the information provided in the application is complete and accurate.

Associated Equipment is equipment that is used in conjunction with a device and directly 

affects the safe use of the device or ensures that the device maintains its integrity (e.g., parts

that move a source, control the shielding of a source, control the radiation levels around a 

device, come in contact with the source). A sealed source or device certificate need not identify 

associated equipment. As a matter of convenience, an applicant for a sealed source or device

may include the description of associated equipment that is compatible with the radiographic 

source or device on the certificate. 

Custom User means a licensee that uses a product that is manufactured in accordance with 

the unique specifications of, and for use by, a single applicant. Typically, no more than two 

different NRC or Agreement State licensees may be custom users of, and may register, the 

same product. However, a custom user may acquire or use (or both) more than one product.

Energy Compensation Source means a small sealed source, with an activity not exceeding 

3.7 MBq (100 μCi), used in a logging tool to provide a reference standard to maintain the tool’s 

calibration when in use.

Inactive Registration Certificate means a registration certificate for a sealed source or device 

that may have been authorized for distribution at one time but is no longer authorized for initial 

distribution. Unless otherwise stated on the registration certificate, the sealed source or device 

included on an inactive registration certificate still may be authorized for use and may continue 

to be licensed. The vendor listed on the registration certificate may be authorized to provide 

service and replacement parts for the sealed source or device and may be authorized to receive 

the sealed source or device from a user for disposal or redistribution to a licensee. However, 

the design of the sealed source or device cannot be changed.

The NRC and the Agreement States may continue to issue licenses to persons to use sealed 

sources or devices that are included on an inactive registration certificate. This typically would 

occur during renewal of a license. However, the fact that the registration certificate is inactive 

serves to alert the license reviewer that the user may not be able to find a firm to service the 
86

device or may not be able to find replacement parts. The license reviewer must ensure that 

emergency procedures, operational support, and services are still applicable.

Inactive Vendor means a vendor that no longer may be authorized to initially distribute the 

sealed source or device listed on a registration certificate but that may be authorized to provide 

services for the sealed source or device. ( Appendix B uses the term)

Mounting means physically positioning the product into its permanent location, including 

installation of fasteners (e.g., mounting bolts). Mounting does not include electrical connection, 

activation, or operation of the product.

National Sealed Source and Device Registry (NSSDR) is maintained by the NRC and 

contains sealed source and device registration certificates that are prepared by the NRC and 

the Agreement States.

Product means any sealed source, device, or associated equipment registered with the NRC or 

an Agreement State.

Registration Certificate Holder means a vendor or custom user of a product that holds a 

certificate of registration with the NRC or an Agreement State. The registration certificate holder 

is responsible for ensuring that the information in the registration certificate is current and 

correct and that products manufactured or distributed conform with the conditions of the 

certificate.

Vendor means any person, licensed or unlicensed, who manufactures or distributes products.

Working Life means the time period or operational cycles during which the product is expected 

to maintain its integrity. The working life should be based on radiotoxicity, total activity, product 

construction, normal operating environments, likely abnormal conditions, fatigue, and wear.
APPENDIX A

APPLICATION AND REVIEW CHECKLIST

A-1

Application and Review Checklist for (Acceptance, 1st, or 2nd) Review for SSD 00-000

SUMMARY DATA

Name and Complete Mailing Address of 

the Applicant:

Name, Title, and Telephone Number of the Individual To Be 

Contacted If Additional Information or Clarification Is Needed by the 

NRC:

The Applicant Is (check one): If the Applicant Is Not the Manufacturer, Provide the Name and 

Complete Mailing Address of the Manufacturer: Custom User

Manufacturer

Distributor

Manufacturer and Distributor

If the Applicant Is a Custom User, Provide 

the Name and Complete Mailing Address 

of the Distributor:

Provide the Name, Complete Mailing Address, and Function of 

Other Companies Involved:

Model Number: Principal Use Code (see Appendix C):

Name Used by the Industry to Identify the 

Product (e.g., Radiography Exposure 

Device, Teletherapy Source, Calibration 

Source):

For Use by:

Specific Licensees Only

General Licensees Only

Both Specific and General Licensees

Persons Exempt from Licensing

Leak-Test Frequency: Principal Section of the 10 CFR that Applies to the User (e.g., 

General Licensees under 10 CFR 31.5): Periodic Leak-Testing is Not 

Required

6 Months Radionuclides and Maximum Activities (including loading 

tolerance): Attached is justification for a leak 

test frequency of greater than 6 

months

CERTIFICATION:

THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE 

BINDING UPON THE APPLICANT.

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT, NAMED ABOVE 

CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10 OF THE CODE OF FEDERAL REGULATIONS, 

PARTS 30 AND 32, AND THAT ALL INFORMATION CONTAINED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR 

KNOWLEDGE AND BELIEF.

Certifying Officer—Typed Name and Title

Signature: Date:
A-2

CHECKLIST

Registration Certificate Holder:

Model:

DESCRIPTION OK/DEF COMMENTS

1st Reviewer 2nd Reviewer

DESCRIPTION/CONSTRUCTION

If the registration certificate holder is requesting to 

register more than one source/device on a certificate, 

are designs similar enough to do so?

Device/source design with complete engineering 

drawings (dimensions, tolerances, list of materials)

Assembly methods (screw, welds, etc.); verify integrity

Source mounting (size and integrity) and security

Is source ANSI classification sufficient (from 

ANSI N43.6-1997 and ISO 2919):

Radiography—Unprotected................................43515

Radiography—In Device ..................................43313

Medical—Radiography ..................................32312

Medical—γ Teletherapy ..................................53524

Medical—Brachytherapy ..................................53211

Medical—Source Applicators .............................43312

γ Gauges—Unprotected ..................................43333

γ Gauges—In Device ..................................43232

β Gauges, Low Energy γ Gauges, or 

X-ray Fluorescence ..................................33222

Oil Well Logging ..................................56522

Portable Moist/Density ..................................43333

Neutron Applications ..................................43323

Calibration Source Activity > 30 μCi (1 MBq) 

........22212

γ Irradiators (I) ...............................................43323

γ Irradiators (II, III) ..................................43424

γ Irradiators (IV) ..................................53424

Chromatography ..................................32211

Static Eliminators ..................................22222

Smoke Detectors ..................................32222

Definition of shutter operation (locked in “off” position, 

not locked in “on” position), fail safe, spacing and 

tolerances

On-Off indicators (description, quantity, location)

Safety interlocks, guards, similar components to 

prevent access to beam or high radiation levels

Corrosion between unlike materials (e.g., aluminum 

and steel, depleted uranium and steel) 

Shielding efficiency and integrity
A-3

CHECKLIST

Registration Certificate Holder:

Model:

DESCRIPTION OK/DEF COMMENTS

1st Reviewer 2nd Reviewer

For medical devices: 

Type of FDA approval:

• Premarket notification (501(k))

• Premarket approval (PMA)

• Investigational Device Exemption (IDE)

• Humanitarian Device Exemption (HDE)

Type of Medical Use:

• Manual brachytherapy, 35.400

• Medical diagnosis, 35.500

• Photon-emitting remote afterloader, 35.600

• Photon-emitting teletherapy unit, 35.600

• Gamma stereotactic radiosurgery unit, 35.600

• Other medical, 35.1000 

List of FDA limitations of use provided

Well logging (10 CFR 39.41) and irradiator

(10 CFR 36.21) sources must be as nondispersible 

and nonsoluble as practical 

See “ANSI and Other Standards” list for references for 

particular source/device designs (See Appendix F, 

e.g., radiography, brachytherapy)
A-4

CHECKLIST

Registration Certificate Holder:

Model:

DESCRIPTION OK/DEF COMMENTS

1st Reviewer 2nd Reviewer

LABELING

Complete and final copy of label attached

Materials, dimensions, colors (note on registration 

certificate if labeling is exempt from the color 

requirements of 10 CFR Part 20)

Attachment and location(s)—visible to users?

Method of attachment is durable and permanent under 

normal conditions of use

Contents: Model no., serial no., isotope, activity, 

manufacturer, date of assay, trefoil symbol, 

“CAUTION—RADIOACTIVE MATERIAL” (depleted 

uranium information must be included)

Is label in compliance with regulatory 

requirements?

CONDITIONS OF USE

Estimated working life of the source/device (years, 

operational cycles)

Actions to be taken when product reaches end of its 

working life

Maximum allowable temperature, vibration, shock, 

corrosion, etc. (during use, handling, storage, and 

transport)

How the device will be used

Meets dose limits of 10 CFR Part 32 for distribution to

general licensees or persons exempt from licensing

PROTOTYPE TESTING/HISTORICAL USE

Tests methods and conditions (for source and device)

Tests results

Years of use (See Section 10.5, “Prototype Testing,”

Operational history of the product)

Similarities to other sources/devices if they are used 

as basis

RADIATION PROFILES

Survey instrument used (e.g.. type, window thickness, 

sensitivity, calibration dates)

Conditions: including environments, scatter (product in 

beam), and use of guards and shields
A-5

CHECKLIST

Registration Certificate Holder:

Model:

DESCRIPTION OK/DEF COMMENTS

1st Reviewer 2nd Reviewer

RADIATION PROFILES (CONTINUED)

Distance from source/surface (per ANSI 538-1979, 

N43.8 - 2001)

Shutter Open and Closed/Source Shielded

Verify that radiation surveys for γ radiation meet 

inverse squared law.

Verify that radiation surveys for non-γ radiation have 

not been calculated using the inverse squared law.

QUALITY ASSURANCE

Materials, subassemblies, services

Assembly methods (screws, welding, etc.)

Dimensions and tolerances

Activity, radiation levels, leak tests

Final inspection

QA Manual and comparison of other (generally) 

accepted guidance (e.g., ANSI/ISO/ASQ 9001-2001)

Additional measures for sealed sources and devices if 

ANSI/ISO/ASQ 9001-2001 is used

INSTALLATION

Fixed, portable, movable, fixed installation but 

portable source housing

Inherent shielding, inaccessibility

Beam access (size of air gap/opening to beam and 

use of interlocks, locks, additional shielding or 

barriers)

Mounting integrity

ACCOMPANYING DOCUMENTATION

Leak tests results and radiation surveys

Operation safety instructions, maintenance, 

calibration, damage/failure, specific warnings, leak 

test, and radiation survey instructions if applicable

For distribution to general licensees, verify that the 

listing of NRC Regions and Agreement States is up to

date and include copies of all pertinent regulations
A-6

CHECKLIST

Registration Certificate Holder:

Model:

DESCRIPTION OK/DEF COMMENTS

1st Reviewer 2nd Reviewer

SERVICING

The following activities may be performed by the persons 

indicated:

Activity By a

General

Licensee

Only by a 

Specific 

Licensee

Will Be Offered

by the Applicant

Installation

Relocation

Maintenance

Repair

Source 

Exchange

Calibration

Leak Testing

Radiation 

Survey

Training

FOREIGN VENDORS

Drop ship

Who and where is source installed

Leak test and radiation surveys

QA in the U.S.

1st Reviewer Signature: Date: 

2nd Reviewer Signature: Date: 
APPENDIX B

ASSIGNING REGISTRATION CERTIFICATE NUMBERS

B-1

Assigning Registration Certificate Numbers

Each sealed source or device registration certificate has a unique registration number. The 

registration number consists of either 10 or 11 characters as shown below:

NR-XXXX-D-YYY-S

Agency Code (NR): The agency code is a two-letter abbreviation of the agency issuing the 

certificate. All certificates issued by the U.S. Nuclear Regulatory Commission (NRC) have NR 

as the agency code.

Vendor Code (XXXX): Each active vendor (who manufactures or distributes products, i.e. 

,manufacturer or distributor) is assigned a unique three or four-digit number on a nationwide 

basis. The registration certificate number will use the vendor code for the distributor. If the 

company is out of business or no longer has an active registration certificate, the vendor is 

classified as inactive vendor, and the vendor code will between 800 and 1000 or between 8000 

and 9000. The NRC maintains the listing of vendor codes and issues new vendor codes. 

Reviewers in Agreement States should contact the NRC to obtain the next available vendor 

code in the National Sealed Source and Device Registry (NSSDR).

Source or Device Code (D): The source or device code is a one-letter code that indicates 

whether a registration certificate is for a sealed source (S), a device (D), or (A) associated 

equipment. The designation (U) is no longer used; it had been used in the past when 

registrations, which had been issued prior to the establishment of the present day practice 

without a clear designation, were transferred into the current system from historical records in 

the early 1980s.

Unit Number (YYY): The unit number is a separate series of three-digit numbers assigned to 

registration certificates for each vendor. These numbers are assigned in sequential order 

starting with 101 for active registration certificates and starting with 801 for inactive registration 

certificates. A new registration for an existing vendor is assigned the next available unit 

number. The agency that regulates the vendor typically controls the issuance of unit numbers.

License Code (S): This one-letter code indicates how the source or device has been registered. 

“S” indicates that it may only be used by specific licensees, “G” indicates it may be used by 

general licensees, “B” indicates that it is intended to be used by both specific and general 

licensees, and “E” indicates that it may be used by persons exempt from licensing.

Parts of the registration certificate numbers are changed when a State becomes an Agreement 

State, or when a vendor moves from a non-Agreement State to an Agreement State, or vice 

versa. Specifically, the following changes are implemented:

• The agency code (NR) designation is changed to that of the Agreement State.

• The vendor code (XXXX) does not change because each vendor has a unique number, 

which applies nationwide.
B-2

• The unit number (YYY) is changed to be the next sequential number for the vendor.

• The Source/Device Code (S/D) does not change

• The license code (S) does not change.
APPENDIX C

PRINCIPAL USE CODES AND DEFINITIONS

C-1

Principal Use Codes and Definitions

A Industrial 

Radiography 

The examination of the structure of materials by 

nondestructive methods that use sealed sources of 

radioactive material.

B Medical 

Radiography 

The process of producing x-ray or gamma ray images to 

assist in medical diagnoses. This code was discontinued with 

the revision of 10 CFR Part 35, “Medical Use of Byproduct 

Material,” implementation date of October 24, 2002. The 

currently used medical codes are listed below.

C Medical 

Teletherapy 

The treatment of disease with gamma radiation from a 

controlled source of radiation located at a distance from the 

patient. This code was discontinued with the revision of 

10 CFR Part 35, implementation date of October 24, 2002. 

The currently used medical codes are listed below.

D Gamma Gauges The use of gamma radiation to measure or control thickness, 

density, levels, interface location, radiation leakage, or 

chemical composition.

E Beta Gauges The use of beta radiation to measure or control thickness, 

density, levels, interface location, radiation leakage, or 

chemical composition.

F Well Logging The lowering and raising of measuring devices or tools that 

may contain radioactive sources into well bases or cavities for 

the purpose of obtaining information about the well or 

adjacent formation.

G Portable Moisture 

Density Gauges 

Portable gauges that use a radioactive sealed source to 

determine or measure the content or density of material. 

Includes hand-held and dolly-transported devices with 

sources.

H General Neutron 

Source 

Applications

All applications, except reactor startup and well logging, that 

use a neutron source. (See NUREG-1556, Volume 14)

I Calibration Sources 

(Activity greater 

than 30 μCi (per

ANSI 43.6)) 

Sources of a known purity and activity that are used to 

determine the variation in accuracy of a measuring instrument 

and to ascertain necessary correction factors.
C-2

J Gamma Irradiation, 

Category I

An irradiation in which the sealed source is completely 

contained in a dry container constructed of solid materials, the 

sealed source is shielded at all times, and human access to 

the sealed source and the volumes undergoing irradiation is 

not physically possible because of the design of the 

irradiation.

K Gamma Irradiation, 

Category II 

A controlled human access irradiation in which the sealed 

source is contained in a dry container constructed of solid 

materials, is fully shielded when not in use, and is exposed 

within a radiation volume that is maintained inaccessible 

during use by an entry control system.

L Gamma Irradiation, 

Category III 

An irradiation in which the sealed source is contained in a 

storage pool (usually containing water), the sealed source is 

shielded at all times, and human access to the sealed source 

and the volume undergoing irradiation is physically restricted 

in its designed configuration and proper mode of use.

M Gamma Irradiation, 

Category IV 

A controlled human access irradiation in which the sealed 

source is contained in a storage pool (usually containing 

water), is fully shielded when not in use, and is exposed within 

a radiation volume that is maintained inaccessible during use 

by an entry control system.

N Ion Generators, 

Chromatography 

The use of an ion-generating source and a device to 

determine the chemical composition of material.

O Ion Generators, 

Static Eliminators 

The use of an ion-generating source and a device to eliminate 

static electricity on a surface or a surrounding area.

P Ion Generators, 

Smoke Detectors 

The use of an ion-generating source and a device to detect 

gases and particles created by combustion.

Q Thermal Generator The use of a radionuclide and a device to produce heat to 

produce energy.

R Gas Sources Sealed sources containing radioactive gas such as krypton-85 

or hydrogen-3.

S Foil Sources Sources that are constructed using thin metal foil. The 

radioactive material may be secured to the foil in a number of 

ways, for example, plating, laminating, or cold welding.
C-3

T Other All uses not covered in other non-medical categories.

U X-Ray 

Fluorescence 

Sources and devices that use radioactive material to excite 

the atoms of samples that in turn emit characteristic X-rays 

and thereby provide a means for sample analysis.

V General Medical 

Use

Includes diagnostic sources and devices such as bone 

mineral analyzers and therapeutic sources and devices such 

as interstitial needles, therapeutic seeds, and ophthalmic 

applicators. This code was discontinued with the revision of 

10 CFR Part 35, implementation date of October 24, 2002. 

The currently used medical codes are listed below.

W Self-Luminous 

Light Source 

A source consisting of a radioactive nuclide or nuclides 

incorporated in solid inactive materials or sealed in a 

protective envelope and incorporating a phosphor to emit 

light.

X Medical Reference 

Sources 

Includes calibration, transmission, and references sources in 

accordance with 10 CFR 35.65, “Authorization for calibration, 

transmission, and reference sources.” Includes flood sources, 

instrument check sources, and spot markers.

Y Calibrators Devices containing calibration sources that are used to 

determine the variation in accuracy of a measuring instrument 

and to determine necessary correction factors.

Z Not used

AA Manual 

Brachytherapy 

For use in manual brachytherapy in accordance with 

10 CFR 35.400, “Use of sources for manual brachytherapy,” 

or equivalent Agreement State regulations.

AB Medical Diagnosis 

Sources 

For use in medical diagnosis in accordance with 

10 CFR 35.500, “Use of sealed sources for diagnosis,” or 

equivalent Agreement State regulations.

AC Photon-Emitting

Remote 

Afterloaders 

For use in Photon-emitting Remote Afterloaders in 

accordance with 10 CFR 35.600, “Use of a sealed source in a 

remote afterloader unit, teletherapy unit, or gamma 

stereotactic radiosurgery unit,” or equivalent Agreement State 

regulations.

AD Photon-Emitting

Teletherapy Units 

For use in photon-emitting teletherapy units in accordance 

with 10 CFR 35.600 or equivalent Agreement State 

regulations.
C-4

AE Gamma 

Stereotactic 

Radiosurgery Units 

For use in Gamma Stereotactic Radiosurgery Units in 

accordance with 10 CFR 35.600 or equivalent Agreement 

State regulations.

AF Other Medical Uses For other medical uses that are regulated under 

10 CFR 35.1000, “Other medical uses of byproduct material 

or radiation from byproduct material,” or equivalent 

Agreement State regulations.
APPENDIX D

STANDARD REGISTRATION CERTIFICATE FORMATS

D-1

Standard Registration Certificate Formats

Table of Contents for Standard Registration Certificate Formats

Title Page

Example of a Source Registration D-2

Example of Specifically Licensed Devices, Generally Licensed 

Devices, or Devices Licensed as Both Specific and General D-8

Example of a Device Registration for an Exempt Product D-17
D-2

Example 1

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF SEALED SOURCE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: PAGE 1 of 5

SOURCE TYPE: Provide a short description of the source type.

MODEL: ABC

MANUFACTURER/DISTRIBUTOR: Name

Street

City, State, Zip (If manufacturer and 

distributor are the same, keep 

subheading as shown. If different, 

delete the word “manufacturer” from 

the subheading.)

MANUFACTURER: Name, Street, City, State, Zip (This 

subheading and information is not 

necessary if the manufacturer and 

distributor are the same.)

ISOTOPE:

List Isotopes

MAXIMUM ACTIVITY: XX Gbq (XX mCi)

(Units should be such that the amount 

is in the 1 to 999 range.)

LEAK TEST FREQUENCY: Not Required or 6 Months

PRINCIPAL USE: (...) See Appendix C

CUSTOM SOURCE: Yes No

CUSTOM USER: Name

Street

City, State Zip

(Delete entire subsection if not 

applicable.)
D-3

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF SEALED SOURCE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: PAGE 2 OF 5

SOURCE TYPE: Provide a short description of the source type.

DESCRIPTION: Provide the complete description of the source.

LABELING:

The source is engraved with the radiation symbol, isotope, activity, 

model number, serial number, date of assay, name of the distributor, 

and the words "CAUTION—RADIOACTIVE MATERIAL." The text is XX mm

(XX in.) high and is on the end/side of the source capsule.

DIAGRAM:

Reference all attachments to the document, including the total number 

of attachments.

CONDITIONS OF NORMAL USE:

The source is designed and manufactured for use in measuring....

The source may be used in harsh environments but shall not be 

subjected to environments that exceed its ANSI N542-1977 

classification, 97C00000.

The estimated working life of the source is XX years.

PROTOTYPE TESTING:

(The reviewers should list either the standard classification and/or 

actual test results.) A prototype of the Model ABC source was 

constructed and subjected to the tests provided in ANSI N 43.6-1997 or 

ISO 2919-1999 and achieved a classification of 96C00000.
D-4

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF SEALED SOURCE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: PAGE 3 OF 5

SOURCE TYPE: Provide a short description of the source type.

EXTERNAL RADIATION LEVELS:

The following dose rates for the Model ABC source containing 37 Gbq 

(1.0 Ci) of Am-241:

Table 1

Distance

Maximum Radiation Level

From Window From Sidewall/Back

(cm) (inches) (μSv/hr) (mrem/hr) (μSv/hr) (mrem/hr)

5 1.97

30 11.81

100 39.37

QUALITY ASSURANCE AND CONTROL:

XXXX Corporation maintains a quality assurance and control program 

which has been deemed acceptable for licensing purposes by the NRC. A 

copy of the program is on file with the NRC. (For medical sources 

that have been manufactured under FDA good manufacturing practices, 

the QA/QC program may not be on file with the NRC.)

(For medical applications) All manufacturing of the Model XXXX 

sources/devices and related operations are to be carried out in 

manufacturing processes consistent with the current Good Manufacturing 

Practices Final Rule, Quality System Regulation, 21 CFR Part 820, 

under the supervision of the Quality Assurance group at 

XXXX Corporation.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

• The source shall be distributed to persons specifically licensed by 

the NRC or an Agreement State.

• (For custom registration) The source shall only be used by the 

custom user listed in this certificate, ABC Corporation.

• Handling, storage, use, transfer, and disposal: To be determined by 

the licensing authority.
D-5

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF SEALED SOURCE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: PAGE 4 OF 5

SOURCE TYPE: Provide a short description of the source type.

• Handling, storage, use, transfer, and disposal: To be determined by 

the licensing authority. In view that these sources exhibit high 

dose rates, the sources should be handled by experienced licensed 

personnel using adequate handling equipment and procedures.

• The source shall be leak tested at intervals not to exceed 6 months 

using techniques capable of detecting 185 Bq (0.005 μCi) of 

removable contamination.

• The source shall not be subjected to conditions that exceed its 

ANSI N43.6-1997 or ISO 2919-1999 classification, 96C00000.

• This registration sheet and the information contained within the 

references shall not be changed without the written consent of the 

NRC.

FDA APPROVAL SUMMARY (For sources in use in accordance with 

10 CFR Part 35 or equivalent Agreement State regulations):

This source was approved by the U.S. Food and Drug Administration, 

Approval No., XXXX, Form 510(k), dated MM/DD/YYYY.

SAFETY ANALYSIS SUMMARY:

Based on review of the Model ABC sealed source, its ANSI 

classification, and the information and test data cited below, we 

{continue to} conclude that the source is acceptable for licensing 

purposes.

Furthermore, we {continue to} conclude that the source would be 

expected to maintain its containment integrity for normal conditions 

of use and accidental conditions which might occur during uses 

specified in this certificate.
D-6

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF SEALED SOURCE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: PAGE 5 OF 5

SOURCE TYPE: Provide a short description of the source type.

REFERENCES:

The following supporting documents for the Model ABC sealed source are 

hereby incorporated by reference and are made a part of this registry 

document.

• XXXX Corporation’s application dated December 25, 0000, with 

enclosures thereto.

• XXXX Corporation’s letters dated July 4, 0000, and 

December 25, 0000, with enclosures thereto.

• XXXX Corporation’s facsimiles dated July 4, 0000, and 

December 25, 0000.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

Date: Reviewer: _____________________________

Name of 1st Reviewer

Date: Concurrence: __________________________

Name of 2nd Reviewer
D-7

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF SEALED SOURCE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: ATTACHMENT 1 OF X

(Insert Drawings)

(Insert Captions)
D-8

Example 2

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 1 OF 8

(For "X", the following designations should be used: "S" for 

specifically licensed devices, "G" for generally licensed devices, and 

"B" for both types.)

Important note for reviewers: Some devices are 

distributed as “B” (both specifically licensed 

and general licensed devices). For these 

devices, the reviewer should clearly 

differentiate between the specifically 

licensed design and the generally licensed 

design in the registration certificate. 

These differences can include, for example,

description of tamper proofing, labeling, 

and other applicable features.

DEVICE TYPE: Provide a short description of the device type.

MODEL: ABC

MANUFACTURER/DISTRIBUTOR: NameStreetCity, State, Zip (If 

manufacturer and distributor are the 

same, keep subheading as shown. If 

different, delete the word 

“manufacturer” from the subheading.)

MANUFACTURER: NameStreetCity, State, Zip (This 

subheading and information is not 

necessary if the manufacturer and 

distributor are the same.)

SEALED SOURCE MODEL 

DESIGNATION: ACME MODEL 123

ISOTOPE:

List Isotopes

MAXIMUM ACTIVITY: XX GBq (XX mCi)

(Units should be such that the amount 

is in the 1 to 999 range.)

LEAK TEST FREQUENCY: Not Required/6 Months

PRINCIPAL USE: (...) See Appendix C

CUSTOM SOURCE: Yes No
D-9

CUSTOM USER: Name

Street

City, State Zip

(Delete entire subsection if not 

applicable.)
D-10

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 2 OF 8

DEVICE TYPE: Provide a short description of the device type.

DESCRIPTION:

Provide the complete description of the device and include, if not 

registered separately, the source(s) used in the device.

LABELING:

The device is labeled in accordance with 10 CFR 20.1901. The labels 

contain the radiation symbol, isotope, activity, model number, serial 

number, name of the distributor, and the words "CAUTION—RADIOACTIVE 

MATERIAL."

(For "G," generally licensed device) When distributed to persons 

generally licensed under 10 CFR 31.5, the device is additionally 

labeled in accordance with 10 CFR 31.5(c)(1) and 32.51.

The labels are made of stainless steel or aluminum, rectangular in 

shape, XX cm × XX cm (XX inches × XX inches), and are permanently 

attached by rivets or screws to the device. A copy of the label is 

shown in Attachment X.

DIAGRAM:

Reference all attachments to the document, including the total number 

of attachments.

CONDITIONS OF NORMAL USE:

The source is designed and manufactured for measuring....

The devices are expected to be subjected to environments typically 

found in laboratories occupied by humans. Since the device is 

portable, it may experience vibration and shock typical during normal 

transportation.

(For "C," custom device) The device will only be used by ABC 

Corporation at their Anytown, Any State, facility.
D-11

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 3 OF 8

DEVICE TYPE: Provide a short description of the device type.

CONDITIONS OF NORMAL USE (Cont.):

The devices are intended for use in industrial gauging applications. 

The devices are typically used in industrial process control 

environments for the measurement of properties of materials in a tank 

or vessel. The devices are designed for the following environments:

Temperature -40° C to 60° C (-40° F to 140° F)

Pressure Atmospheric

Vibration Ranges from zero to mild

Corrosion Ranges from zero to highly corrosive vapors

Fire NEC Division 2, hazardous area possible

Explosion NEC Division 2, hazardous area possible

The estimated working life of the device is XX years or XX operational 

cycles.

PROTOTYPE TESTING:

(The reviewers should list either the standard classification and/or 

the actual test results.)

A prototype of the device has been tested in accordance with ANSI/ISO 

standard ... and has achieved a classification of.... The device 

passed the tests in accordance with the acceptance criteria included 

in the standard.

The sealed sources used in the device have been tested by their 

manufacturers and have achieved the following ANSI (ANSI N-43.6-1997 

or ISO 2919-1999) classifications:

Manufacturer Model ANSI Classification

ABC AMCL 77C64344

DEF NER-465 C33232

HIJ PH-55 C33232

The sealed source contained in the device has achieved an 

ANSI N43.6-1997 or ISO 2919-1999 classification of 96C00000.
D-12

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 4 OF 8

DEVICE TYPE: Provide a short description of the device type.

PROTOTYPE TESTING (Cont.):

The sealed source contained in the device has achieved an 

ISO 2919-1999 classification of C00000.

A prototype of the Model XXXX was constructed and subjected to the 

tests listed below. No malfunction occurred, nor was there any loss 

of shielding or containment integrity.

Temperature 110° C (230° F) for a period of 7 hours.

Vibration Approximately 30 cps at an amplitude of 0.76 mm 

(0.03 in.) for 90 minutes.

OFF/ON 

Mechanism

Operated by a pneumatic cylinder for a total of 

9,320 OFF/ON cycles.

Impact Dropped three times from a height of 122 cm (4 ft).

Penetration Dropped a 5.9 kg (13 lb), 3.2 cm (1.25 in.)diameter 

steel rod from a height of 102 cm (40 in.).

EXTERNAL RADIATION LEVELS:

XXXX Corporation reports that the radiation levels from the device are 

not discernable from background.

XXXX Corporation reports that the radiation levels from the device do 

not exceed 50 μSv/hr (5 mR/hr) at 30.5 cm (12 in.) from the surface of 

the device.

The following dose rates were reported by the manufacturer for the 

Model ABC transmission gauge containing a 37 GBq (1.0 Ci) of Am-241 

sealed source:

Table 1

Distance

Maximum Radiation Level with Shutter

Closed From Window From Sidewall/Back

(cm) (inches) (mSv/hr) (mrem/hr) (mSv/hr) (mrem/hr)

5 1.97

30 11.81

100 39.37
D-13

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 5 OF 8

DEVICE TYPE: Provide a short description of the device type.

EXTERNAL RADIATION LEVELS (Cont.):

Table 2

Distance

Maximum Radiation Level with Shutter

Open From Window From Sidewall/Back

(cm) (inches) (mSv/hr) (mrem/hr) (mSv/hr) (mrem/hr)

30 11.81

100 39.37

100 39.37

The dose rates were taken with no material present in the measuring 

area. XXXX Corporation indicates this represents the highest 

radiation levels of any possible configuration.

QUALITY ASSURANCE AND CONTROL:

XXXX Corporation maintains a quality assurance and control program 

which has been deemed acceptable for licensing purposes by the NRC. A 

copy of the program is on file with the NRC. (For medical devices 

that have been manufactured under FDA's Good Manufacturing Practices, 

the QA/QC program may not be on file with the NRC.)

(For medical applications) All manufacturing of the Model XXXX 

sources/devices and related operations are to be carried out in 

manufacturing processes consistent with the current Good Manufacturing 

Practices Final Rule, Quality System Regulation, 21 CFR Part 820, 

under the supervision of the Quality Assurance group at 

XXXX Corporation.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE:

• (For "S," specifically licensed device) The device shall be 

distributed to persons specifically licensed by the NRC or an 

Agreement State.

• (For "B," both specifically and generally licensed device) The 

device may be distributed to specific or general licensees of the 

NRC or an Agreement State.

• (For "G," generally licensed device) The device shall be distributed 

to persons generally licensed by the NRC or an Agreement State.

• (For custom device) The device shall only be distributed to the 

custom user, ABC Corporation.
D-14

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 6 OF 8

DEVICE TYPE: Provide a short description of the device type.

LIMITATIONS AND/OR OTHER CONSIDERATIONS OF USE (Cont.):

• (For "S," specifically licensed device) Handling, storage, use, 

transfer, and disposal: To be determined by the licensing 

authority.

• (For "G" generally licensed device as well as for "B” both 

specifically and generally licensed device) Handling, storage, use, 

transfer, and disposal: To be determined by the licensing authority 

or as required by 10 CFR 31.5 or Agreement State equivalent.

• The device shall be leak tested at intervals not to exceed X months 

using techniques capable of detecting 185 Bq (0.005 μCi) of 

removable contamination.

• The Model XXXX sealed source is approved by the NRC for use in the 

Model ABC. The source is not registered on a separate certificate.

• (For "G" generally licensed device as well as for "B” both 

specifically and generally licensed device) The generally licensed 

user is authorized to perform certain maintenance on the device (see 

the device operation manual). These services include....

• REVIEWER NOTE: Neither the distributor nor manufacturer of the 

device will provide servicing for the device.

• This registration sheet and the information contained within the 

references shall not be changed without the written consent of the 

NRC.

FDA APPROVAL SUMMARY (For sources in use in accordance with 

10 CFR Part 35 or equivalent Agreement State regulations):

This source was approved by the U.S. Food and Drug Administration, 

Approval No. XXXX, Form 510(k), dated MM/DD/YYYY.

SAFETY ANALYSIS SUMMARY:

• (For "S," specifically licensed device) Based on our review of the 

information and test data cited below and the past history of 

similar designs, we continue to conclude) that the Model XXXX 

devices are acceptable for licensing purposes.

• (For "S," specifically licensed device) Furthermore, we continue to 

conclude that these devices would be expected to maintain their 

integrity for normal and accidental conditions of use which might 

occur during the uses specified in this registration sheet.
D-15

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 7 OF 8

DEVICE TYPE: Provide a short description of the device type.

SAFETY ANALYSIS SUMMARY (Cont.):

The distributor has submitted sufficient information to provide 

reasonable assurance that:

• (For "G" generally licensed device as well as for "B” both 

specifically and generally licensed device) The device can be safely 

operated by persons not having training in radiological protection.

• (For "G" generally licensed device as well as for "B” both 

specifically and generally licensed device) Under ordinary 

conditions of handling, storage, and use of the device, the 

byproduct material contained in the device will not be released or 

inadvertently removed from the source housing, and it is unlikely 

that any person will receive in any period of one year a dose in 

excess of 10 percent of the limits specified in 10 CFR 20.1201(a).

• (For "G" generally licensed device as well as for "B” both 

specifically and generally licensed device) Under accident 

conditions associated with handling, storage, and use of the source 

housing, it is unlikely that any person would receive an external 

radiation dose or dose commitment in excess of the dose to the 

appropriate organ as specified in the following chart:

PART OF BODY DOSE

Whole body; head and trunk; active 

blood-forming organs; gonads; or lens of eye

0.15 Sv (15 rem)

Hands and forearms; feet and ankles; 

localized areas of skin averaged over areas 

no larger than 1 cm2 (0.15 in2)

2.0 Sv (200 rem)

Other organs 0.50 Sv (50 rem)

Based on review of the Model XXXX, and the information and test data 

cited below, we {continue to} conclude that the device is acceptable 

for licensing purposes.

Furthermore, we {continue to} conclude that the device would be 

expected to maintain its containment integrity for normal conditions 

of use and accidental conditions which might occur during uses 

specified in this certificate.
D-16

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-X DATE: PAGE 8 OF 8

DEVICE TYPE: Provide a short description of the device type.

REFERENCES:

The following supporting documents for the Model ABC are hereby 

incorporated by reference and are made a part of this registry 

document.

• XXXX Corporation’s application dated December 25, 0000, with 

enclosures thereto.

• XXXX Corporation’s letters dated July 4, 0000, and 

December 25, 0000, with enclosures thereto.

• XXXX Corporation’s facsimiles dated July 4, 0000, and 

December 25, 0000.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

Date: Reviewer: _____________________________

Name of 1st Reviewer

Date: Concurrence: __________________________

Name of 2nd Reviewer
D-17

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: ATTACHMENT 1 OF X

(Insert Drawings)

(Insert Captions)
D-18

Example 3

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-E DATE: PAGE 1 OF 2

DEVICE TYPE: Short description of the device type

MODEL: ABC

MANUFACTURER/DISTRIBUTOR: NameStreetCity, State, Zip (If 

manufacturer and distributor are the 

same, keep subheading as shown. If 

different, delete the word 

“manufacturer” from the subheading.)

MANUFACTURER: NameStreetCity, State, Zip (This 

subheading and information is not 

necessary if the manufacturer and 

distributor are the same.)

SEALED SOURCE MODEL 

DESIGNATION: ACME MODEL 123

ISOTOPE:

List Isotopes

MAXIMUM ACTIVITY: XX GBq (XX mCi)

(Units should be such that the amount 

is in the 1 to 999 range.)

LEAK TEST FREQUENCY: Not Required 

PRINCIPAL USE: (...) See Appendix C

CUSTOM SOURCE: Yes No
D-19

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-D-***-E DATE: PAGE 2 OF 2

DEVICE TYPE: Short description of the device

DESCRIPTION:

Provide a concise, basic description of the device; if more than one 

model is registered, provide the differences between models.

REFERENCES:

The following supporting documents for the Model ABC (Short 

description of the device) are hereby incorporated by reference and 

are made a part of this registry document.

• XXXX Corporation’s application dated December 25, 0000, with 

enclosures thereto.

• XXXX Corporation’s letters dated July 4, 0000, and 

December 25, 0000, with enclosures thereto.

• XXXX Corporation’s facsimiles dated July 4, 0000, and 

December 25, 0000.

ISSUING AGENCY:

U.S. Nuclear Regulatory Commission

Date: Reviewer: _____________________________

Name of 1st Reviewer

Date: Concurrence: __________________________

Name of 2nd Reviewer
D-20

REGISTRY OF RADIOACTIVE SEALED SOURCES AND DEVICES

SAFETY EVALUATION OF DEVICE

(AMENDED IN ITS ENTIRETY)

NO.: NR-***-S-***-S DATE: ATTACHMENT 1 OF X

(Insert Drawings)

(Insert Captions)
APPENDIX E

CHECKLIST FOR REQUESTS TO WITHHOLD INFORMATION FROM 

PUBLIC DISCLOSURE

E-1

Checklist for Requests to Withhold Information from Public 

Disclosure

Withholding from public inspection shall not affect the right, if any, of persons properly and 

directly concerned to inspect the documents. If the need arises, the U.S. Nuclear Regulatory 

Commission (NRC) may send copies of this information to NRC consultants working in that 

subject area. The NRC will ensure that the consultants have signed the appropriate 

agreements for handling proprietary information.

If the basis for withholding this information from public inspection should change in the future 

such that the information could then be made available for public inspection, the applicant 

should promptly notify the NRC. The applicant also should understand that the NRC may have 

cause to review this determination in the future if, for example, the scope of a Freedom of 

Information Act request includes the information in question. In all review situations, if the NRC 

makes a determination that the information should be made publicly available, the agency will 

notify the applicant in advance of any public disclosure.
E-2

Checklist for Requests to Withhold Information from Public Disclosure

In order to request that the NRC withhold information contained in an application from public 

disclosure, the applicant must submit the information and application, including an affidavit, in 

accordance with 10 CFR 2.390, “Public inspections, exemptions, requests for withholding.” 

The applicant should submit all of the following:

[ ] A proprietary copy of the information. Brackets should be placed around the material 

considered to be proprietary. This copy should be marked as proprietary.

[ ] A non-proprietary copy of the information. Applicants should white out or black out the 

proprietary portions (i.e., those in the brackets), leaving the non-proprietary portions 

intact. This copy should not be marked as proprietary.

[ ] An affidavit that—

[ ] Is notarized.

[ ] Clearly identifies (such as by name or title and date) the document to be withheld.

[ ] Clearly identifies the position of the person executing the affidavit. This person 

must be an officer or upper-level management official who has been delegated the 

function of reviewing the information sought to be withheld and who has been 

authorized to apply for withholding on behalf of the company.

[ ] States that the company submitting the information is the owner of the information 

or is required, by agreement with the owner of the information, to treat the 

information as proprietary.

[ ] Provides a rational basis for holding the information in confidence.

[ ] Fully addresses the following issues:

[ ] Is the information submitted to and received by the NRC in confidence? 

Provide details.

[ ] To the best of the applicant’s knowledge, is the information currently 

available in public sources?

[ ] Does the applicant customarily treat this information, or this type of 

information, as confidential? Explain why.

[ ] Would public disclosure of the information be likely to cause substantial harm 

to the competitive position of the applicant? If so, explain why in detail. The 

explanation should include the value of the information to your company, the 

amount of effort or money expended in developing the information, and the 

ease or difficulty with which others might be able to acquire the information.
APPENDIX F

INDUSTRY AND CONSENSUS STANDARDS

F-1

Industry and Consensus Standards

Brachytherapy:

ANSI N44.2-1984 “For Leak-Testing Radioactive Brachytherapy Sources”

ANSI N44.1-1984 “Integrity and Test Specifications for Selected 

Brachytherapy Sources”

Gauges:

ISO 7205-1986(E) “Radionuclide Gauges—Gauges Designed for Permanent 

Installation”

ANSI N43.8-2008 “Classification of Industrial Ionizing Radiation Gauging 

Devices” 

Irradiators:

ANSI N433.1-1977 “Safe Design and Use of Self-Contained Dry Source 

Storage Gamma Irradiators (Category I)” (withdrawn)

ANSI N43.7-2007

ANSI N43.10-2001

ANSI N43.15-2001

“Self Contained, Dry Source Storage Irradiators (Category 

I)”

“Safe Design and Use of Panoramic, Wet Source Storage 

Gamma Irradiators (Category IV) and Dry Source Storage 

Gamma Irradiators (Category II)”

“Self Contained, Wet Source Storage Irradiators 

(Category III)”

Light Sources:

ANSI N43.4-2005 “Classification of Radioactive Self-Luminous Light Sources”

Power Generators:

IAEA No. 33 “Guide to the Safe Design, Construction, and Use of 

Radioisotopic Power Generators for Certain Land and Sea 

Applications”

Quality Assurance:

ANSI/ISO/ASQ 9001-2008 “Quality Management Systems—Requirements”

Radiography:

ANSI N43.5-1993 “General Safety Standard for Installations Using 

Non-Medical X-Ray and Sealed Gamma-Ray Sources, 

Energies Up to 10 MeV”
F-2

ANSI N43.9-1991 “For Gamma Radiography—Specifications for Design and 

Testing of Apparatus”

ANSI N432-1980 “Radiological Safety for the Design and Construction of 

Apparatus for Gamma Radiography”

ISO 3999-2004 “Apparatus for Gamma Radiography—Specification”

Smoke Detectors:

OECD/NEA 1977 “Recommendations for Ionization Chamber Smoke 

Detectors in Implementation of Radiation Protection 

Standards”

Sources (General):

ISO 2919-1999 “Radiation Protection—Sealed Radioactive Sources—

General Requirements and Classification”

ISO 9978-1992 “Radiation Protection—Sealed Sources—Leakage Test 

Methods”

ANSI N43.6-2007 “Sealed Radiation Sources, Classification” (Revision of 

ANSI N5.10-1968)

ANSI N5.10-1968 “Sealed Radiation Sources, Classification”

IAEA-TECDOC-1344, 

July 2003

“Characterization of Radioactive Sources”

Teletherapy:

ANSI N449.1-1984 “Procedures for Periodic Inspection of Cobalt-60 and 

Cesium-137 Teletherapy Equipment”

X-Ray Fluorescence:

ANSI N43.2-2001 “Radiation Safety for X-Ray Diffraction and Fluorescence 

Analysis Equipment”

ANSI N537-1976 “Radiological Safety Standard for the Design of 

Radiographic and Fluoroscopic Industrial X-Ray Equipment”

Miscellaneous:

ANSI N43.3-2008 “Installations Using Non-Medical X-Ray and Sealed 

Gamma-Ray Sources, Energies Up to 10 MeV”

NCRP Report No.49 “Structural Shielding Design and Evaluation for Medical Use

of X-Rays and Gamma Rays of Energies Up to 10 MeV”

BS EN 46001-1997 “Application of EN ISO-9001 to the Manufacture of Medical 

Devices”
APPENDIX G

CHECKLIST FOR REVIEWING QUALITY ASSURANCE PROGRAMS

G-1

The checklist in this appendix is designed to help the applicant or the Sealed Source and 

Device license reviewer in reviewing quality assurance (QA) programs for completeness. The 

checklist is designed as an aid and may not be all-inclusive. In addition, certain items may not 

be applicable to all applicants.

Table G.1 Checklist for Reviewing QA Programs

Questions

Program/Implementation

Comments

Yes No

1. Does the vendor have a QA 

manual or set of instructions 

defining the QA program?

2. Is the manual up to date?

3. Is the manual approved and 

signed by a designated official 

from each department?

ORGANIZATION

4. Is the organizational structure of 

the applicant documented in the 

QA manual?

5. Are all the QA personnel listed, 

along with all their 

responsibilities?

6. Is the QA Director someone in 

upper management not directly 

responsible for manufacturing or 

production?

7. Does the QA Director have 

continual involvement in the QA 

program?

8. Is the NRC contact listed and up 

to date?

9. Do the QA Manager and QA 

Director have the authority to halt 

production?
G-2

Table G.1 Checklist for Reviewing QA Programs (continued)

Questions

Program/Implementation

Comments

Yes No

PERSONNEL

10. Does the applicant have 

procedures to ensure up-to-date 

records of all employees’ 

qualifications?

DESIGN AND DOCUMENT CONTROL

11. Are there procedures for ensuring 

that all documents contain all 

pertinent information and conform 

to all pertinent regulations and 

specifications?

12. Are there procedures for handling 

document and design changes?

13. Do the procedures ensure that all 

appropriate departments are 

notified of the changes?

14. Do the procedures ensure that 

documents under revision are not 

used?

15. Are all changes documented?

16. Do the procedures ensure the 

documents and changes are 

checked and approved before 

release?

17. Do the procedures include 

notifying regulatory agencies of 

any changes?

18. Do the procedures ensure 

alternative approaches in the 

absence of specifications?
G-3

Table G.1 Checklist for Reviewing QA Programs (continued)

Questions

Program/Implementation

Comments

Yes No

19. Is there a history file, for each 

document, that includes previous 

versions, document changes, and 

reasons for the changes?

20. Are copies on file of all up-to-date 

documents for each job?

21. Are there procedures for verifying

the adequacy of suppliers?

22. Are there records of all audits of 

suppliers?

23. Are audits of suppliers performed 

at intervals less than 3 years?

24. Are there procedures for receipt 

inspection?

25. Do receipt inspection procedures

 verify:

• correct sizes?

• quantity?

• document and specification 

conformance?

• paperwork?

26. Are there procedures for receipt of 

nonconforming material?

27. Are there records of receipt 

inspections, including 

nonconforming material?
G-4

Table G.1 Checklist for Reviewing QA Programs (continued)

Questions

Program/Implementation

Comments

Yes No

28. Do all purchase orders contain:

• scope of work?

• technical requirements?

• identification of the documents 

that must accompany the 

order?

• identification of the records 

that the applicant must keep?

• signature of the appropriate 

individual?

29. Are there records of all 

purchases?

30. Are there inventory procedures?

31. Do inventory procedures include:

• special handling? 

• marking? 

• tagging? 

• labeling? 

• segregating? 

• paperwork procedures?

• handling of nonconforming 

material? 

32. Does the inventory system have 

provisions for material with shelf 

life?

33. Does the inventory system have 

provisions to ensure that the 

correct material is used in 

production?
G-5

Table G.1 Checklist for Reviewing QA Programs (continued)

Questions

Program/Implementation

Comments

Yes No

34. Are periodic physical inventories 

performed?

35. Does the system ensure that 

products that are marked or 

segregated as complete have 

passed their final inspections and 

testing?

PRODUCTION PROCEDURES AND PROCESSES

36. Are there procedures that describe 

production processes?

37. Is there a flowchart describing the 

flow of material and inspection 

hold points?

38. Are there procedures for 

in-process and final inspection 

and testing of the device?

39. Do inspection procedures include: 

• acceptance criteria? 

• receipt criteria? 

• at what points to perform 

in-process inspections and 

tests?

• procedures for determining 

sample sizes? 

• procedures for final inspection 

and testing? 

• provisions for nonconforming 

material? 

40. Are there records for inspections 

of production procedures?
G-6

Table G.1 Checklist for Reviewing QA Programs (continued)

Questions

Program/Implementation

Comments

Yes No

41. Are there records of all 

inspections and testing, including 

date and person performing the 

inspection or test?

42. Is there a system for marking or 

segregating items that have been 

inspected or tested?

43. Does final inspection include an 

operational check and removal 

contamination test of 100% of the 

devices?

NONCONFORMING MATERIALS

44. Are there procedures for handling 

nonconforming items received 

from a supplier or customer or 

found during production?

45. Are nonconforming materials 

tagged or segregated from 

production?

46. Are there procedures for the 

disposition of nonconforming 

materials and for the introduction 

of materials back into production?

47. Are there records of 

nonconforming material?

PACKAGING AND TRANSPORTATION

48. Are there procedures for 

inspecting packaging and the form 

of transportation?
G-7

Table G.1 Checklist for Reviewing QA Programs (continued)

Questions

Program/Implementation

Comments

Yes No

49. Do these procedures ensure that 

all paperwork and manuals are 

included with the shipment or are 

being shipped separately to the 

customer?

50. Are there records of all packaging 

and shipping reports and 

inspections?

DEVIATIONS AND CUSTOMER COMPLAINTS

51. Are there procedures for 

evaluating deviations and 

customer complaints?

52. Are there procedures for informing 

the appropriate members of the 

organization and the NRC of 

deviations?

53. Are there procedures for informing 

customers of devices that may 

contain a deviation?

54. Are there records of all deviations 

and customer complaints?

55. Do customer complaint records 

contain: 

• name of complainant? 

• nature and date of complaint? 

• corrective action taken? 

• cause of failure? 

• model and serial number of 

the device? 
G-8

Table G.1 Checklist for Reviewing QA Programs (continued)

Questions

Program/Implementation

Comments

Yes No

56. Are there procedures for trend 

analysis of deviations and 

complaints?

57. Is trend analysis performed at 

intervals that do not exceed 

1 year?

AUDITS

58. Does the applicant have 

procedures for auditing its QA 

program?

59. Do the procedures include 

acceptance criteria?

60. Do the procedures ensure that all 

records and procedures are up to 

date?

61. Do audits include verification of 

audits of suppliers?

62. Is the auditor responsible for any 

of the matters being audited?

63. Do records include deficient areas 

in the program and corrective 

action taken?

64. Are all deficiencies found during 

audits corrected in a timely 

manner?

65. Are all records signed and dated 

by the appropriate member of the 

organization?
APPENDIX H

SAFETY CULTURE STATEMENT OF POLICY

H-1

Safety Culture

The safety culture policy statement was published in the Federal Register (76 FR 34773) on 

June 14, 2011 and can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-06-14/pdf/2011-

14656.pdf. It is also posted in NRC’s Agencywide Documents Access and Management 

System (ADAMS) Accession Number ML11146A047. 

Safety Culture Policy Statement

The purpose of this Statement of Policy is to set forth the Commission’s expectation that 

individuals and organizations establish and maintain a positive safety culture commensurate

with the safety and security significance of their activities and the nature and complexity of their 

organizations and functions. This includes all licensees, certificate holders, permit holders,

authorization holders, holders of quality assurance program approvals, vendors and suppliers of 

safety-related components, and applicants for a license, certificate, permit, authorization, or 

quality assurance program approval, subject to NRC authority. The Commission encourages

the Agreement States, Agreement State licensees and other organizations interested in nuclear 

safety to support the development and maintenance of a positive safety culture, as articulated in

this Statement of Policy.

Nuclear Safety Culture is defined as the core values and behaviors resulting from a collective 

commitment by leaders and individuals to emphasize safety over competing goals to ensure

protection of people and the environment. Individuals and organizations performing regulated

activities bear the primary responsibility for safety and security. The performance

of individuals and organizations can be monitored and trended and, therefore, may be used to 

determine compliance with requirements and commitments and may serve as an indicator of

possible problem areas in an organization’s safety culture. The NRC will not monitor or trend 

values. These will be the organization’s responsibility as part of its safety culture program.

Organizations should ensure that personnel in the safety and security sectors have an 

appreciation for the importance of each, emphasizing the need for integration and balance to

achieve both safety and security in their activities. Safety and security activities are closely 

intertwined. While many safety and security activities complement each other, there may be

instances in which safety and security interests create competing goals. It is important that 

consideration of these activities be integrated so as not to diminish or adversely affect either; 

thus, mechanisms should be established to identify and resolve these differences. A safety 

culture that accomplishes this would include all nuclear safety and security issues associated 

with NRC regulated activities.

Experience has shown that certain personal and organizational traits are present in a positive 

safety culture. A trait, in this case, is a pattern of thinking, feeling, and behaving that

emphasizes safety, particularly in goal conflict situations, e.g., production, schedule, and the 

cost of the effort versus safety. It should be noted that although the term “security” is not

expressly included in the following traits, safety and security are the primary pillars of the NRC’s 

regulatory mission. Consequently, consideration of both safety and security issues,

commensurate with their significance, is an underlying principle of this Statement of Policy.
H-2

The following are traits of a positive safety culture:

(1) Leadership Safety Values and Actions—Leaders demonstrate a commitment to safety in 

their decisions and behaviors;

(2) Problem Identification and Resolution—Issues potentially impacting safety are promptly

identified, fully evaluated, and promptly addressed and corrected commensurate with their 

significance;

(3) Personal Accountability—All individuals take personal responsibility for safety;

(4) Work Processes—The process of planning and controlling work activities is implemented so 

that safety is maintained;

(5) Continuous Learning—Opportunities to learn about ways to ensure safety are sought out 

and implemented;

(6) Environment for Raising Concerns—A safety conscious work environment is maintained 

where personnel feel free to raise safety concerns without fear of retaliation, intimidation, 

harassment, or discrimination;

(7) Effective Safety Communication—Communications maintain a focus on safety;

(8) Respectful Work Environment—Trust and respect permeate the organization; and

(9) Questioning Attitude—Individuals avoid complacency and continuously challenge existing 

conditions and activities in order to identify discrepancies that might result in error

or inappropriate action.

There may be traits not included in this Statement of Policy that are also important in a positive 

safety culture. It should be noted that these traits were not developed to be used for inspection

purposes.

It is the Commission’s expectation that all individuals and organizations, performing or 

overseeing regulated activities involving nuclear materials, should take the necessary steps to

promote a positive safety culture by fostering these traits as they apply to their organizational 

environments. The Commission recognizes the diversity of these organizations and 

acknowledges that some organizations have already spent significant time and resources in the 

development of a positive safety culture. The Commission will take this into consideration as 

the regulated community addresses the Statement of Policy.



UNITED STATES 

NUCLEAR REGULATORY COMMISSION

WASHINGTON, DC 20555-0001

--------------------

OFFICIAL BUSINESS
NUREG-1556, Vol. 3

Revision 2, Draft

Consolidated Guidance about Materials Licenses: Applications for 

Sealed Source and Device Evaluation and Registration