Contains Nonbinding Recommendations
Medical X-Ray Imaging Devices 
Conformance with IEC Standards
Guidance for Industry and Food and 
Drug Administration Staff
Document issued on February 21, 2023.
Document originally issued on May 8, 2019
For questions regarding this document contact Office of Health Technology 8 (OHT8): Office of 
Radiological Health at RadHealth@fda.hhs.gov. 
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health Contains Nonbinding Recommendations
Preface
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov.  Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.  
Identify all comments with the docket number FDA-2016-D-2049.  Comments may not be acted 
upon by the Agency until the document is next revised or updated. 
Additional Copies
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance.  Please include the document 
number GUI01400014 and complete title of the guidance in the request. Contains Nonbinding Recommendations
Table of Contents
I.  Introduction .............................................................................................................................. 1
II.  Background .............................................................................................................................. 2
A. Device Regulations ............................................................................................................. 2
B. EPRC Regulations .............................................................................................................. 3
C. Avoidance of Duplication ................................................................................................... 4
III. Scope ........................................................................................................................................ 4
A. Devices Addressed in the Guidance ................................................................................... 4
B. Standards Addressed in the Guidance................................................................................. 6
IV. Policy ........................................................................................................................................ 6
A. Electronic Products - Performance Standards..................................................................... 7
B. Medical Devices  510(k) Clearance .................................................................................. 8
V.  Submission of Declarations of Conformity .............................................................................. 9
VI. Certification .............................................................................................................................. 9
VII. Information to be Provided to Assemblers and Others .......................................................... 10
VIII.  Compliance and Enforcement ........................................................................................... 11
Appendix A: Applicability of IEC Standards to Specific Device Types ...................................... 13 Medical X-Ray Imaging Devices 
Conformance with IEC Standards
Guidance for Industry and 
Food and Drug Administration Staff 
This guidance represents the current thinking of the Food and Drug Administration (FDA 
or Agency) on this topic.  It does not establish any rights for any person and is not binding 
on FDA or the public.  You can use an alternative approach if it satisfies the requirements 
of the applicable statutes and regulations.  To discuss an alternative approach, contact the 
FDA staff responsible for this guidance as listed on the title page. 
I.  Introduction 
This guidance describes FDAs policy regarding the regulation of medical x-ray imaging 
equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDAs 
regulations that apply to medical devices and electronic products. In this guidance, FDA is 
seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C 
(Electronic Product Radiation Control (EPRC)) of the FD&C Act with International 
Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure more 
efficient and consistent regulatory review of submissions for these products. The guidance also 
provides recommendations to industry on how to comply with the applicable requirements. FDA 
has determined that industry conformance to certain IEC standards would provide, at a 
minimum, the same level of protection of the public health and safety from electronic radiation 
as certain EPRC regulatory standards. 
Manufacturers and importers of medical x-ray imaging equipment must follow the current EPRC 
regulations and procedures or provide a declaration of conformity to equivalent IEC standards, as 
outlined in this guidance, to fulfill the requirements of the EPRC regulation. Using a declaration 
of conformity to equivalent IEC standards reduces duplication of efforts by manufacturers and 
allows FDA to provide more efficient and consistent regulatory reviews of submissions relating 
to medical x-ray imaging devices. 
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.1 For more information 
regarding use of consensus standards in regulatory submissions, please refer to FDA guidance 
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm  
1 titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for 
Medical Devices.2
  
In general, FDA's guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agency's current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidance means that something is suggested or recommended, but 
not required.
II.  Background
Medical x-ray imaging equipment may fall under the definition of both a medical device, under 
section 201(h) of the FD&C Act, and an electronic product, under section 531(2) of the FD&C 
Act.  As such, these devices may be subject to the provisions of the FD&C Act and FDAs 
regulations3 that apply to medical devices4 and electronic products.5
While the legal authorities relating to medical devices and electronic products focus primarily on 
safety/effectiveness and radiation safety, respectively, there is some overlap in the requirements 
established by these authorities. FDA is issuing this guidance to clarify the relevant applicable 
standards and to help to ensure an efficient and consistent regulatory review of submissions for 
these devices. This guidance describes current Agency thinking in the following areas:
1)  Product conformance to IEC standards; and
2)  Compliance with EPRC performance standards.
A. Device Regulations
FDA categorizes medical devices into one of three classes  Class I, II, or III  based on their 
risks and the regulatory controls necessary to provide a reasonable assurance of safety and 
effectiveness.  Class I devices generally pose the lowest risk to the patient and/or user and Class 
III devices pose the highest risk.  
  For Class I devices, manufacturers generally must comply with general controls 
authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 
516 (banned devices), 518 (notification and other remedies), 519 (records and reports), 
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
3 The regulations specific to medical devices and electronic products are found in 21 CFR Chapter I Subchapter H 
and Subchapter J, respectively.
4 For additional information regarding medical device regulation, see https://www.fda.gov/medical-devices/device-
advice-comprehensive-regulatory-assistance/overview-device-regulation 
5 For additional information regarding electronic product regulation, see https://www.fda.gov/radiation-emitting-
products/electronic-product-radiation-control-program/getting-radiation-emitting-product-market-frequently-asked-
questions 
2 and 520 (general provisions) of the FD&C Act (see 21 CFR 860.3(c)(1)).  The following 
regulations set forth requirements related to these general controls:
o  21 CFR 801: Labeling;
o  21 CFR 803: Medical Device Reporting;
o  21 CFR 807: Establishment Registration and Device Listing for Manufacturers and 
Initial Importers of Devices; and 
o  21 CFR 820: Quality System Regulation. 
Most Class I devices can be legally marketed without FDA clearance of a 510(k) 
submission.  
 For Class II devices, manufacturers must comply with general controls and applicable 
special controls and are subject to premarket notification (510(k)) requirements prior to 
marketing, unless otherwise exempted (21 CFR 860.3(c)(2)).6
 For Class III devices, manufacturers must comply with general controls and generally 
must receive FDA approval of a premarket approval application (PMA) that demonstrates 
the safety and effectiveness of the device prior to marketing (21 CFR 860.3(c)(3)).
B. EPRC Regulations 
The EPRC regulations are aimed at protecting the public from hazardous and unnecessary 
exposure to radiation from electronic products. By regulation, FDA identified types of electronic 
products,7 including diagnostic x-ray systems and their major components, and established 
product performance standards for those products to control radiation. 
Manufacturers and importers of x-ray imaging devices must comply with applicable 
requirements, including, but not limited to:
 21 CFR 1002.20: Reporting of accidental radiation occurrences
 21 CFR 1002.30: Records to be maintained by manufacturers
 21 CFR 1002.40: Records to be obtained by dealers and distributors
 21 CFR Part 1003: Notification of defects or failure to comply 
 21 CFR Part 1004: Repurchase, repairs, or replacement of electronic products
 21 CFR 1010.2: Certification
 21 CFR 1020.30: Diagnostic x-ray systems and their major components
 21 CFR 1020.31: Radiographic equipment
6 Certain radiologic devices were exempt from 510(k) submissions under section 510(m)(1)(A) of the FD&C Act in 
82 FR 31976, subject to the limitations in 21 CFR 892.9.
7 These types include: Television receivers (21 CFR 1020.10); Cold-cathode gas discharge tubes (21 CFR 1020.20); 
Diagnostic x-ray systems and their major components (21 CFR 1020.30); Cabinet x-ray systems (21 CFR 1020.40); 
Microwave ovens (21 CFR 1030); Laser products (21 CFR 1040.10); Sunlamp products and ultraviolet lamps 
intended for use in sunlamp products (21 CFR 1040.20); High-intensity mercury vapor discharge lamps (21 CFR 
1040.30).
3  21 CFR 1020.32: Fluoroscopic equipment8
 21 CFR 1020.33: Computed tomography (CT) equipment
C. Avoidance of Duplication
Industry has previously raised concerns about overlapping requirements in the medical device 
and EPRC regulations for products that are both medical devices and electronic products. The 
Agency has addressed this overlap through guidance and amendments to the EPRC regulations:
1. Laser Products (see Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-
22; Laser Notice No. 50,9 and Laser Products - Conformance with IEC 60825-1 Ed. 3 
and IEC 60601-2-22 Ed. 3.1; Laser Notice No. 5610), and
2. Radiological Health Regulations; Amendments to Records and Reports for Radiation 
Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-
ray, Laser and Ultrasonic Products.11
III.  Scope
A. Devices Addressed in the Guidance 
This guidance addresses diagnostic x-ray imaging systems and their major components (see 21 
CFR 1002.1 and 21 CFR 1020.30(a)(1)). Most diagnostic x-ray imaging systems and their major 
components are classified as Class I or II devices. Tables 1 and 2 include the regulations and 
product codes for these devices. 
8 For additional information on complying with EPRC performance standards for fluoroscopic equipment, see the 
guidance titled Policy Clarification for Certain Fluoroscopic Equipment Requirements at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-clarification-certain-
fluoroscopic-equipment-requirements 
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-products-
conformance-iec-60825-1-and-iec-60601-2-22-laser-notice-no-50 
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-products-
conformance-iec-60825-1-ed-3-and-iec-60601-2-22-ed-31-laser-notice-no-56 
11 88 FR 3638 available at https://www.federalregister.gov/documents/2023/01/20/2023-00922/radiological-health-
regulations-amendments-to-records-and-reports-for-radiation-emitting-electronic 
4 Table 1  Class II devices that are covered by this guidance
Regulation  Regulation Description Associated Applicable 
Number Product Codes
21 CFR 872.1800 Extraoral source x-ray system EHD, MUH
21 CFR 872.1810 Intraoral source x-ray system EAP
21 CFR 892.1170 Bone densitometer KGI
21 CFR 892.1600 Angiographic x-ray system IZI
21 CFR 892.1610 Diagnostic x-ray beam limiting-device KPW, IZW, IZX
21 CFR 892.1630 Electrostatic x-ray imaging system IXK
21 CFR 892.1650 Image-intensified fluoroscopic x-ray system JAA, OWB, OXO, RCC
21 CFR 892.1660 Non-image-intensified fluoroscopic x-ray system JAB
21 CFR 892.1670 Spot-film device IXL
21 CFR 892.1680 Stationary x-ray system KPR, MQB, MWP
21 CFR 892.1710 Mammographic x-ray system IZH
21 CFR 892.1715 Full-field digital mammography system MUE
21 CFR 892.1720 Mobile x-ray system IZL
21 CFR 892.1730 Photofluorographic x-ray system IZG
21 CFR 892.1740 Tomographic x-ray system IZF
21 CFR 892.1750 Computed tomography x-ray system JAK, OAS
21 CFR 892.1860 Radiographic film/cassette changer KPX
21 CFR 892.1980 Radiologic table KXJ, IXQ, IXR, IZZ
Table 2  Class I devices that are covered by this guidance
Regulation Number Regulation Description Associated Product 
Codes
21 CFR 892.1700 Diagnostic x-ray high voltage generator IZO
21 CFR 892.1760 Diagnostic x-ray tube housing assembly ITY
21 CFR 892.1830 Radiologic patient cradle KXH
21 CFR 892.1880 Wall-mounted radiographic cassette holder IXY
Some imaging devices are hybrids; that is, they are combinations of more than one imaging 
component (e.g., Positron Emission Tomography (PET) and Computed Tomography (CT)). In 
the situation where one of the components has an applicable EPRC standard, the policy 
described in this guidance applies to that component.
This guidance does not address radiation therapy products because there are no EPRC 
performance standards promulgated for these products. These devices are cleared for market 
through the 510(k) process.12
12 For a list of recognized consensus standards applicable to radiation therapy products, see FDAs product 
classification database at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm. 
Classification regulations for radiologic therapeutic devices can be found in 21 CFR 892 subpart F.
5 B. Standards Addressed in the Guidance
To avoid duplication and provide an efficient and consistent regulatory review of submissions 
relating to medical x-ray imaging devices, this guidance clarifies the relevant applicable 
voluntary consensus standards for medical x-ray systems and components. FDA has recognized 
the following IEC standards that apply to one or more of the devices covered by this guidance 
(see Appendix A):
 IEC 60601-1-3 Medical electrical equipment  Part 1-3: General requirements for basic 
safety and essential performance  Collateral Standard: Radiation protection in 
diagnostic X-ray equipment;
 IEC 60601-2-28 Medical electrical equipment - Part 2-28: Particular requirements for 
the basic safety and essential performance of X-ray tube assemblies for medical 
diagnosis;
 IEC 60601-2-43 Medical electrical equipment  Part 2-43: Particular requirements for 
the safety and essential performance of X-ray equipment for interventional procedures;
 IEC 60601-2-44 Medical electrical equipment  Part 2-44: Particular requirements for 
the basic safety and essential performance of X-ray equipment for computed tomography; 
 IEC 60601-2-45 Medical electrical equipment  Part 2-45: Particular requirements for 
the basic safety and essential performance of mammographic X-ray equipment and 
mammographic stereotactic devices; 
 IEC 60601-2-54 Medical electrical equipment  Part 2-54: Particular requirements for 
the basic safety and essential performance of X-ray equipment for radiography and 
radioscopy;
 IEC 60601-2-63 Medical electrical equipment  Part 2-63: Particular requirements for 
the basic safety and essential performance of dental extra-oral X-ray equipment; and
 IEC 60601-2-65 Medical electrical equipment  Part 2-65: Particular requirements for 
the basic safety and essential performance of dental intra-oral X-ray equipment.
IV.  Policy
FDA has determined that conformance to certain IEC standards would provide, at a minimum, 
the same level of protection of the public health and safety from electronic radiation ascertain 
 
EPRC performance standards. FDA recommends that manufacturers elect to conform to a 
recognized and applicable IEC standard to meet certain requirements of the performance 
standards outlined in Table 3, below. Conformance must be to a version, including corrigenda 
and amendments, of the applicable IEC standards that is recognized by FDA at the time 
6 conformance is declared.13 For more information regarding transition periods associated with the 
recognition of newer versions of consensus standards, see Appropriate Use of Voluntary 
Consensus Standards in Premarket Submissions for Medical Devices.14
A. Electronic Products - Performance Standards
The IEC standards described in section 3b of this guidance (see Appendix A for additional 
details) are applicable to many parts of the performance standards for diagnostic x-ray systems 
(see Table 3) established under section 534 of the FD&C Act.
FDA has determined that conformance to the identified IEC standards would provide, at a 
minimum, the same level of protection of the public health and safety from electronic product 
radiation as the requirements in 21 CFR 1020.30 (in part), 1020.31, 1020.32 (in part), and 
1020.33 (in part) (see Table 3). Therefore, a manufacturer or importer that has submitted a 
declaration of conformity to the applicable IEC standards through the process discussed in 
sections 5 and 6 of this guidance would be deemed to have met certain performance standard 
requirements in 21 CFR 1020.30, 1020.31, 1020.32, and 1020.33, assuming the criteria in 
section 514(c) of the FD&C Act are satisfied.  
Table 3  EPRC requirements deemed to be met based on conformity to applicable IEC 
standard(s)
21 CFR 1020.30(c),  Diagnostic x-ray systems and their major components
(h), (k), (l), (m), (n), 
(o)
21 CFR 1020.31 Radiographic equipment
21 CFR 1020.32(a),  Fluoroscopic equipment
(b), (c), (d)(1), (d)(2), 
(d)(3)(i)  (iv), (d)(4), 
(f), (h), (i), (j), (k)
21 CFR 1020.33(a),  Computed tomography (CT) equipment 
(b). (c), (f), (g), (h), (i), 
(j) 
Some sections of the electronic product regulations are not adequately addressed or are outside 
the scope of the IEC standards identified in section 3b of this guidance (see Appendix A). For 
these parts of the electronic product regulations, FDA has determined that there is no applicable 
portion of the IEC standards that can be used to meet the requirements. Consequently, 
manufacturers, importers, and their devices would not be deemed to have met the requirements 
identified in Table 4 below solely based on conformance with the identified IEC standards.
13 Section 514(c)(1)(B) of the FD&C Act.
14 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
7 Table 4  EPRC requirements that would not be deemed to be met based solely on 
conformity to IEC standards 
21 CFR 1002 Subparts  Records and Reports 
A, C, D, E, F
21 CFR 1010.3 Identification
21 CFR 1010.4 Variances (from EPRC requirements only)
21 CFR 1020.30(a) Applicability
21 CFR 1020.30(b) Definitions (see note immediately below this table)
21 CFR 1020.30(d) Assemblers responsibility
21 CFR 1020.30(e) Identification of x-ray components
21 CFR 1020.30(g) Information provided to assemblers
21 CFR 1020.30(j) Warning label
21 CFR 1020.30(q) Modification of certified components
21 CFR 1020.32(d)(3)(v) Lateral plane patient entrance point
21 CFR 1020.32(g) Source-skin distance
21 CFR 1020.33(d) Quality assurance
Note: The FDA medical device regulations and IEC use different definitions of extra-oral and 
intra-oral x-ray systems. IEC standards 60601-2-63 and 60601-2-65 use the location of the image 
receptor to determine whether the device is an extra-oral device or an intra-oral device. FDA 
uses the location of the x-ray source to make the distinction (21 CFR 872.1800 and 21 CFR 
872.1810). This difference in definitions means that some devices classified as an Extra-oral 
source x-ray system under 21 CFR 872.1800 will be defined as an intra-oral x-ray system by the 
IEC. In these cases, the applicable IEC standard is 60601-2-65 (for intraoral x-ray systems), and 
manufacturers who choose to conform to IEC standards should submit a declaration of 
conformity to IEC 60601-2-65.  
B. Medical Devices  510(k) Clearance
To obtain 510(k) clearance, manufacturers must establish the substantial equivalence of their 
new device to a legally marketed predicate that does not require a premarket approval application 
(PMA). This is done by showing their new device has the same intended use, and technological 
characteristics that either: are the same, or; are different, but the differences do not raise different 
questions of safety and effectiveness than the predicate (see section 513(i) of the FD&C Act). 
Conformance with recognized consensus standards may in some situations support a substantial 
equivalence determination (see guidance entitled Appropriate Use of Voluntary Consensus 
Standards in Premarket Submissions for Medical Devices).15 Moreover, declaration(s) of 
conformity to recognized consensus standard(s) could be sufficient to eliminate the need for 
manufacturers to submit in their 510(k) (and for FDA to review) the complete testing reports for 
those aspects of the device addressed by the standards. While there are few mandatory FDA 
standards that apply to medical devices, there are numerous national and international voluntary 
15 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
8 consensus standards that the Agency has reviewed and recognized.16 A discussion of the 
substantial equivalence review process is found in the guidance entitled The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications [510(k)].17
V.  Submission of Declarations of Conformity
If manufacturers and importers elect to conform to a recognized and applicable IEC standard to 
meet the applicable requirements of an EPRC performance standard, they must complete a 
declaration of conformity that certifies that the device is in conformity with the standard (see 
section 514(c)(1)(B) of the FD&C Act) and include the declaration as part of a premarket 
submission, as applicable to the device type. If a premarket submission is not required for that 
device type, then the declaration should be kept as part of the manufacturers records. 
Information on such declarations is available in the guidance entitled Appropriate Use of 
Voluntary Consensus Standards in Premarket Submissions for Medical Devices.18
VI.  Certification
Manufacturers of diagnostic x-ray systems, and their major components, for which an applicable 
EPRC performance standard is in effect, including those that conform to applicable IEC 
standards to meet EPRC performance standards, must provide certifications for their products 
(see 21 CFR 1010.2(a)). To properly certify their product, manufacturers must furnish product 
certifications to dealers or distributors, at the time of delivery, that the product conforms to the 
IEC standards that are declared in the associated declaration of conformity and any other 
standards in Chapter J (Radiological Health) of Title 21 of the CFR (such as parts of 21 CFR 
1020.30) (see 21 CFR 1010.2(a)). 
The certification must be provided on a label or tag permanently affixed to or inscribed on a 
product, including major components for which there is an applicable EPRC performance, so as 
to be legible, readily accessible to view when the product is fully assembled for use, and in the 
English language (see 21 CFR 1010.2(b)).
The certification label or tag should include a modified statement of compliance, such as:
Complies with 21 CFR Subchapter J including section [insert FDA performance 
standard CFR number(s)], partially by conforming with IEC [insert IEC Standard number 
and edition number], dated [Insert publication date of the FDA-recognized IEC standard], 
[add, as appropriate] including corrigenda dated [insert publication dates of the FDA-
recognized corrigenda] and amendments dated [insert publication dates of the FDA-
recognized amendments], in accordance with section 514(c)(1)(A) of the FD&C Act as 
16 For more information, see the FDA Recognized Standards Database, available at 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
17 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-
evaluating-substantial-equivalence-premarket-notifications-510k 
18 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
9 outlined in "Medical X-Ray Imaging Devices: Conformance with IEC Standards, dated 
[Insert date of final guidance issuance].
For example, for a CT device:
Complies with 21 CFR Subchapter J including sections 21 CFR 1020.30 and 1020.33, 
partially by conforming with IEC 60601-2-44 ed1.0 (2009), including Amendment 1 
(2012), in accordance with section 514(c)(1)(A) of the FD&C Act as outlined in 
"Medical X-Ray Imaging Devices: Conformance with IEC Standards, dated [date of 
issuance of final guidance].
Under 21 CFR 1010.2(c), this certification must be based upon a test, in accordance with the 
standard, of the individual article to which it is attached or upon a testing program which is in 
accordance with good manufacturing practice. The manufacturers quality system should 
address various aspects of radiation safety and conformity to standards through design controls. 
Testing results should be documented and placed in the firms records. 
VII. Information to be Provided to Assemblers and Others
Manufacturers of diagnostic x-ray equipment components listed in 21 CFR 1020.30(a)(1) are 
required by 21 CFR 1020.30(g) to provide instructions for assembly, installation, adjustment, 
and testing, (AIAT) to assure that the product will comply with applicable performance standard 
provisions. This requirement in the performance standard helps to ensure that diagnostic x-ray 
equipment, the characteristics of which may require adjustment upon assembly, installation, and 
thereafter, will continue to comply with radiation safety requirements and thus protect the public 
from unnecessary exposure to radiation. As outlined in Table 4, section 1020.30(g) is not met 
through conformance to applicable IEC standards.
To comply with the instructions for the AIAT requirement of 21 CFR 1020.30(g), a 
manufacturer who elects to declare conformity to IEC standards to satisfy other sections of the 
EPRC performance standards outlined in Table 3 should include in their AIAT documentation a 
Radiation Safety Specification and Testing Comparison Document.19 The Radiation Safety 
Specification and Testing Comparison Document (the Document) should provide information 
that enables, for example, an assembler, qualified medical physicist, or state radiation control 
program inspector, to test the device and determine whether it conforms to the applicable IEC 
radiation safety specifications, and not the EPRC performance standards. Although the 
Document may be limited to only those specifications and would not indicate full compliance 
with the relevant EPRC performance standards, FDA recommends that manufacturers format 
their AIAT documentation so that all radiation safety specifications and test methods, including 
acceptance and constancy testing, are available in a format that is practical for users testing the 
equipment.
19 An example Radiation Safety Specification and Testing Comparison Document can be found at 
https://www.nema.org/standards/view/radiation-safety-specification-and-testing-comparison-document-for-medical-
x-ray-imaging-devices-general-radiography-and-fl 
10 At minimum, the Document should include:
a.  The radiation safety specifications that apply to the device, where those specifications 
would not otherwise meet the comparable EPRC performance standards;
b.  The IEC document number, version, and specific clause(s) under which each such 
specification may be found;
c.  The EPRC performance standard requirement being replaced by the IEC standard; and
d.  The test method and acceptance criterion.
Availability of Documents online enables easy access by assemblers and other personnel. Access 
can be provided on an individual manufacturers website or in a centralized database. 
Information on how to access the Document should be included with the devices accompanying 
documents. Additionally, if the device includes user documentation20 that is provided 
electronically, inclusion of the Document as part of the electronic documentation may be helpful 
for assemblers and other personnel.
VIII.  Compliance and Enforcement
This guidance does not limit the Agencys ability to pursue an enforcement action if 
manufacturers do not comply with applicable laws and regulations.
If a manufacturer is using a declaration of conformity to comply with certain requirements, as 
discussed in this guidance, the manufacturer or importer must declare conformance to certain 
IEC standards, with that conformance being based on a testing program.21 The manufacturers 
quality system must address various aspects of radiation safety and conformity to standards 
through design verification and validation.22 Testing results must be documented and placed in 
the firms records as part of the design history file23 for the device and are subject to inspection 
in accordance with 21 CFR 820.180. FDA will consider a product to be in violation of the 
electronic product performance standards if FDA finds that a manufacturers testing program 
does not assure the adequacy of safeguards against hazardous electronic product radiation or that 
it does not assure that electronic products comply with the appropriate standards (see 21 CFR 
1010.2(c)). 
By declaring conformance with the IEC standards, corrigenda, and amendments identified in this 
guidance, manufacturers declare that they have established design specifications that relate to 
radiation emission. When a diagnostic x-ray system fails to conform to design specifications 
relating to the emission of electronic product radiation, the system has an electronic product 
defect.24 Thus, failure to meet any of the requirements relating to the emission of electronic 
20 This is the same as the IEC term accompanying documents.
21 See FDAs guidance Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 
Devices, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices, for more information about testing that 
supports a declaration of conformity. 
22 21 CFR 820.30.
23 21 CFR 820.30(j).
24 21 CFR 1003.2(b).
11 product radiation of an IEC standard, corrigenda, or amendment to which a manufacturer 
declares conformance, is an electronic product defect and is cause for notification and 
repurchase, repair, or replacement, as defined in 21 CFR parts 1003 and 1004. 
This guidance does not change FDAs policy towards enforcement of correction of such defects. 
Manufacturers and importers must notify FDA upon discovery of a radiation safety defect, as 
required by 21 CFR 1003.10. Also, as required by 21 CFR 1003.11, FDA will notify industry 
when the Agency makes such discoveries. As required by 21 CFR part 1004, the manufacturer 
must repurchase, repair, or replace defective products without charge, under a plan approved by 
FDA. FDA will review and approve or reject all corrective action plans, as required by 21 CFR 
 
1004.6.
12 Appendix A: Applicability of IEC Standards to Specific 
Device Types
The IEC uses a tiered structure for its standards: general standards, collateral standards, and 
particular standards. The base standard (e.g., IEC 60601-1 for medical electrical equipment) is 
called the general standard. Collateral standards (e.g., IEC 60601-1-3 for radiation protection in 
diagnostic x-ray equipment) provide general specifications for safety that are applicable to a 
subgroup of devices covered by the general standard, or a specific characteristic of all equipment 
covered by the general standard that is not fully addressed in the general standard (e.g., alarm 
systems). Particular standards apply to specific types of equipment (e.g., IEC 60601-2-43 for 
interventional fluoroscopy systems), and may replace, add to, amend, or remove conditions 
contained in the general or collateral standards, as appropriate for the specific type of equipment 
under consideration. Particular standards may also add other basic safety and essential 
performance conditions. 
In particular standards, the term this standard is used to make reference to the general standard, 
any applicable collateral standards, and the particular standard, taken together. Therefore, 
conformance to a particular standard includes conformance to any collateral standards and the 
general standard in the same series (e.g., IEC 60601), as well as to any other particular standards 
included as normative. However, a condition in a particular standard takes priority over any 
conflicting conditions in collateral and general standards in the same series and normative 
particular standards (e.g., conditions in IEC 60601-2-43 take precedence over any conflicting 
conditions in IEC 60601-2-54, IEC 60601-1-3, and IEC 60601-1). 
The chart below indicates the IEC standards that apply to different devices classified in the CFR 
after taking into consideration the IECs tiered structure system. The far-left column lists the 
classification regulation numbers for devices within the scope of this guidance. To determine 
which IEC standard(s) applies to a device:
1.  Find the row containing the classification regulation in the left column.
2.  Trace the row across the rest of the table and note which columns are marked with an 
X.
3.  The column headings for the columns marked with an X provide the names of the IEC 
standards that apply to that device.
13 Table 6  Applicability of IEC Standards to Specific Medical Device Classifications
IEC  
IEC   IEC   IEC   IEC  
60601-2-43 IEC  
60601-1-3 IEC   IEC   60601-2-54 60601-2-63 60601-2-65
Classification  Interventional  60601-2-44
Diagnostic  60601-2-28 60601-2-45 Radiography  Extra-Oral  Intra-Oral 
Regulation X-ray  Computed 
X-ray  X-Ray Tube Mammography and  Dental  Dental 
Equipment Tomography
Equipment Radioscopy Equipment Equipment
21 CFR 
872.1800 X X   X  
EHD, MUH
21 CFR 
872.1810 X X
EAP
21 CFR 
892.1170 X X
KGI
21 CFR 
892.1600 X X X
IZI
21 CFR 
892.1610
X X
KPW, IZW, 
IZX
21 CFR 
892.1630 X X
IXK
21 CFR 
892.1650
X X X
JAA, OWB, 
OXO, RCC
21 CFR 
892.1660 X X
JAB
21 CFR 
892.1670 X
IXL
1 IEC  
IEC   IEC   IEC   IEC  
60601-2-43 IEC  
60601-1-3 IEC   IEC   60601-2-54 60601-2-63 60601-2-65
Classification  Interventional  60601-2-44
Diagnostic  60601-2-28 60601-2-45 Radiography  Extra-Oral  Intra-Oral 
Regulation X-ray  Computed 
X-ray  X-Ray Tube Mammography and  Dental  Dental 
Equipment Tomography
Equipment Radioscopy Equipment Equipment
21 CFR 
892.1680
X X
KPR, MQB, 
MWP
21 CFR 
892.1700 X X
IZO
21 CFR 
892.1710 X X
IZH
21 CFR 
892.1715 X X
MUE
21 CFR 
892.1720 X X
IZL
21 CFR 
892.1730 X X
IZG
21 CFR 
892.1740 X X
IZF
21 CFR 
892.1750 X X
JAK, OAS
21 CFR 
892.1760 X X
ITY
21 CFR 
892.1830 X
KXH
21 CFR 
X
892.1860
2 IEC  
IEC   IEC   IEC   IEC  
60601-2-43 IEC  
60601-1-3 IEC   IEC   60601-2-54 60601-2-63 60601-2-65
Classification  Interventional  60601-2-44
Diagnostic  60601-2-28 60601-2-45 Radiography  Extra-Oral  Intra-Oral 
Regulation X-ray  Computed 
X-ray  X-Ray Tube Mammography and  Dental  Dental 
Equipment Tomography
Equipment Radioscopy Equipment Equipment
KPX
21 CFR 
892.1880 X
IXY
21 CFR 
892.1980
X
KXJ, IXQ, 
IXR, IZZ
The FDA medical device regulations and IEC use different definitions of extra-oral and intra-oral x-ray systems. IEC standards 
60601-2-63 and 60601-2-65 use the location of the image receptor to determine whether the device is an extra-oral device or an intra-
oral device. FDA uses the location of the x-ray source to make the distinction (21 CFR 872.1800 and 21 CFR 872.1810). This 
difference in definitions means that some devices classified as an Extra-oral source x-ray system under 21 CFR 872.1800 will be 
defined as an intra-oral x-ray system by the IEC. In these cases, the applicable IEC standard is 60601-2-65, for intraoral x-ray systems, 
and manufacturers who choose to conform to IEC standards should submit a declaration of conformity to IEC 60601-2-65.
IEC 60601-2-43 applies to devices under 21 CFR 892.1650 that are intended to be used in interventional procedures. The applicable 
standard for all other devices under 21 CFR 892.1650 is IEC 60601-2-54.
See theFDA Recognized Consensus Standards Database25 for a current list of FDA-recognized consensus standards.
25 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm 
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