Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15765 

ingredient(s) and is produced using the 

same manufacturing processes as the 

approved comparator product or article. 

Alternatively, a biowaiver may be 

granted without direct comparison to 

the pioneer product’s formulation and 

manufacturing process if it can be 

shown that the active pharmaceutical 

ingredient(s) (API) is the same as the 

pioneer product, is soluble, and that 

there are no ingredients in the 

formulation likely to cause adverse 

pharmacologic effects. For the purpose 

of evaluating soluble powder oral 

dosage form products and Type A 

medicated articles, solubility can be 

demonstrated in one of two ways: ‘‘USP 

definition’’ approach or ‘‘Dosage 

adjusted’’ approach. The respondents 

for this collection of information are 

pharmaceutical companies 

manufacturing animal drugs. FDA 

estimates the burden for this collection 

of information as follows in tables 1 and 

2 of this document. The source of the 

above data is records of generic drug 

applications over the past 10 years. 

In the Federal Register of October 24, 

2011 (76 FR 65733), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. FDA received one 

comment, which, however, did not 

address the questions posed in 60-day 

notice regarding the collection of 

information. The comment supported 

the bioequivalence program but 

suggested a revision to the 

determination of bioequivalence, which 

relates to the substance of the scientific 

recommendations in the guidance 

document. Under FDA’s good guidance 

practices regulations (21 CFR 

10.115(f)(4)), the public may suggest at 

anytime that FDA revise a guidance 

document and under 21 CFR 

10.115(g)(5), FDA will revise guidance 

documents in response to comments 

when appropriate. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN FOR WATER SOLUBLE POWDERS 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Same formulation/manufacturing process approach ........... 1 1 1 5 5 

Same API/solubility approach .............................................. 5 5 5 10 50 

Total burden hours ....................................................... ........................ ........................ ........................ ........................ 55 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN FOR TYPE A MEDICATED ARTICLES 1

Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Same formulation/manufacturing process approach ........... 2 2 2 5 10 

Same API/solubility approach .............................................. 10 10 10 20 200 

Total burden hours ....................................................... ........................ ........................ ........................ ........................ 210 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: March 8, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6391 Filed 3–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

028 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

publication containing modifications 

the Agency is making to the list of 

standards FDA recognizes for use in 

premarket reviews (FDA recognized 

consensus standards). This publication, 

entitled ‘‘Modifications to the List of 

Recognized Standards, Recognition List 

Number: 028’’ (Recognition List 

Number: 028), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit either electronic or 

written comments concerning this 

document at any time. See section VII 

of this document for the effective date 

of the recognition of standards 

announced in this document. 

ADDRESSES: Submit written requests for 

single copies of ‘‘Modifications to the 

List of Recognized Standards, 

Recognition List Number: 028’’ to the 

Division of Small Manufacturers, 

International and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Silver Spring, MD 20993. Send two selfaddressed adhesive labels to assist that 

office in processing your requests, or fax 

your request to 301–847–8149. Submit 

electronic comments concerning this 

document to standards@cdrh.fda.gov. 

Submit written comments concerning 

this document, or recommendations for 

additional standards for recognition, to 

the contact person (see FOR FURTHER

INFORMATION CONTACT). This document 

may also be accessed on FDA’s Internet 

site at http://www.fda.gov/

MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. See section 

VI of this document for electronic access 

to the searchable database for the 

current list of FDA recognized 

consensus standards, including 

Recognition List Number: 028 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Colburn, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

mstockstill on DSK4VPTVN1PROD with NOTICES

15766 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

Ave., Bldg. 66, Rm. 3628, Silver Spring, 

MD 20993, 301–796–6574. 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C Act) (21 U.S.C. 360d). Amended 

section 514 allows FDA to recognize 

consensus standards developed by 

international and national organizations 

for use in satisfying portions of device 

premarket review submissions or other 

requirements. 

In a notice published in the Federal 

Register of February 25, 1998 (63 FR 

9561), FDA announced the availability 

of a guidance entitled ‘‘Recognition and 

Use of Consensus Standards.’’ The 

notice described how FDA would 

implement its standard recognition 

program and provided the initial list of 

recognized standards. 

Modifications to the initial list of 

recognized standards, as published in 

the Federal Register, are identified in 

table 1 of this document. 

TABLE 1—PREVIOUS PUBLICATION OF

STANDARD RECOGNITION LISTS

February 25, 1998 (63 FR 9561) 

October 16, 1998 (63 FR 55617) 

July 12, 1999 (64 FR 37546) 

November 15, 2000 (65 FR 69022) 

TABLE 1—PREVIOUS PUBLICATION OF

STANDARD RECOGNITION LISTS— 

Continued 

May 7, 2001 (66 FR 23032) 

January 14, 2002 (67 FR 1774) 

October 2, 2002 (67 FR 61893) 

April 28, 2003 (68 FR 22391) 

March 8, 2004 (69 FR 10712) 

June 18, 2004 (69 FR 34176) 

October 4, 2004 (69 FR 59240) 

May 27, 2005 (70 FR 30756) 

November 8, 2005 (70 FR 67713) 

March 31, 2006 (71 FR 16313) 

June 23, 2006 (71 FR 36121) 

November 3, 2006 (71 FR 64718) 

May 21, 2007 (72 FR 28500) 

September 12, 2007 (72 FR 52142) 

December 19, 2007 (72 FR 71924) 

September 9, 2008 (73 FR 52358) 

March, 18, 2009 (74 FR 11586) 

September 8, 2009 (74 FR 46203) 

May 5, 2010 (75 FR 24711) 

June 10, 2010 (75 FR 32943) 

October 4, 2010 (75 FR 61148) 

March 14, 2011 (76 FR 13631) 

August 2, 2011 (76 FR 46300) 

These notices describe the addition, 

withdrawal, and revision of certain 

standards recognized by FDA. The 

Agency maintains ‘‘hypertext markup 

language (HTML)’’ and ‘‘portable 

document format (PDF)’’ versions of the 

list of ‘‘FDA Recognized Consensus 

Standards.’’ Both versions are publicly 

accessible at the Agency’s Internet site. 

See section VI of this document for 

electronic access information. Interested 

persons should review the 

supplementary information sheet for the 

standard to understand fully the extent 

to which FDA recognizes the standard. 

II. Modifications to the List of 

Recognized Standards, Recognition List 

Number: 028 

FDA is announcing the addition, 

withdrawal, correction, and revision of 

certain consensus standards the Agency 

will recognize for use in satisfying 

premarket reviews and other 

requirements for devices. FDA will 

incorporate these modifications in the 

list of FDA Recognized Consensus 

Standards in the Agency’s searchable 

database. FDA will use the term 

‘‘Recognition List Number: 028’’ to 

identify these current modifications. 

In table 2 of this document, FDA 

describes the following modifications: 

(1) The withdrawal of standards and 

their replacement by others, (2) the 

correction of errors made by FDA in 

listing previously recognized standards, 

and (3) the changes to the 

supplementary information sheets of 

recognized standards that describe 

revisions to the applicability of the 

standards. 

In section III of this document, FDA 

lists modifications the Agency is making 

that involve the initial addition of 

standards not previously recognized by 

FDA. 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

A. Anesthesia 

1–15 ................... ........................ ISO 5361–4 Second edition 1987–12–15 Tracheal tubes—Part 4: 

Cole type.

Contact person. 

1–18 ................... ........................ ISO 8359 Second edition 1996–12–15 Oxygen concentrators for medical use—Safety requirements.Contact person. 

1–35 ................... ........................ ISO 5361 First edition 1999–09–15 Corrected and reprinted 1999–12– 

15 Anaesthetic and respiratory equipment—Tracheal tubes and 

connectors.

Contact person. 

1–36 ................... ........................ ISO 5366–3 Second edition 2001–08–15 Anaesthetic and respiratory 

equipment—Tracheostomy tubes—Part 3: Pediatric tracheostomy 

tubes.

Contact person. 

1–44 ................... ........................ ISO 5366–1 Fourth edition 2000–12–15 Anaesthetic and respiratory 

equipment—Tracheostomy tubes—Part 1: Tubes and connectors 

for use in adults.

Contact person. 

1–46 ................... ........................ ISO 5367 Fourth edition 2000–06–01 Breathing tubes intended for 

use with anaesthetic apparatus and ventilators.

Contact person. 

1–56 ................... ........................ CGA V–7.1:1997 (Reaffirmed 2008) Standard Method of Determining 

Cylinder Valve Outlet Connections for Medical Gases.

Contact person. 

1–57 ................... ........................ ASTM F1101–90 (Reapproved 2003) 1 Standard Specification for Ventilators Intended for Use During Anesthesia.Contact person. 

1–58 ................... ........................ ASTM G175–03 (Reapproved 2011) Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications.Reaffirmation. 

1–60 ................... ........................ IEC 60601–2–12 [ISO 10651–1] Second edition 2001–10 Medical 

electrical equipment—Part 2–12: Particular requirements for the 

safety of lung ventilators—Critical care ventilators.

Contact person. 

1–62 ................... ........................ ISO 5356–1 Third edition 2004–05–15 Anaesthetic and respiratory 

equipment—Conical connectors: Part 1: Cones and sockets.

Contact person. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15767 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

1–69 ................... ........................ ASTM F 1464–93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary Use.Contact person. 

1–70 ................... ........................ ASTM F 1246–91 (Reapproved 2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure 

Ventilators and Ventilator Circuits.

Contact person. 

1–72 ................... ........................ ISO 10651–5 First edition 2006–02–01 Lung ventilators for medical 

use—Particular requirements for basic safety and essential performance—Part 5: Gas-powered emergency resuscitators.

Contact person. 

1–73 ................... ........................ ISO 10651–4 First edition 2002–03–01 Lung ventilators—Part 4: Particular requirements for operator-powered resuscitators.Contact person. 

1–75 ................... ........................ ISO 5362 Fourth edition 2006–06–01 Anaesthetic reservoir bags ........ Contact person. 

1–79 ................... ........................ ISO 26825 First edition 2008–08–15 Corrected version 2009–09–15 

Anaesthetic and respiratory equipment—User-applied labels for syringes containing drugs used during anaesthesia—Colours, design 

and performance.

Contact person. 

B. Biocompatibility 

2–87 ................... 2–174 ISO 10993–10 Third Edition 2010–08–01 Biological evaluation of 

medical devices—Part 10: Tests for irritation and skin sensitization.

Withdrawn and replaced with 

newer version. 

2–93 ................... ........................ ASTM F763–04 (Reapproved 2010) Standard Practice for Short-Term 

Screening of Implant Materials.

Reaffirmation. 

2–94 ................... ........................ ASTM F981–04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone.Reaffirmation. 

2–108 ................. ........................ ASTM F1905–98 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity.Withdrawn. 

2–114 ................. ........................ ASTM F1877–05 (Reapproved 2010) Standard Practice for Characterization of Particles.Reaffirmation. 

2–117 ................. ........................ ANSI/AAMI/ISO 10993–3:2003(R)2009 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.Extent of recognition and Contact 

person. 

2–118 ................. ........................ ANSI/AAMI/ISO 10993–11:2006/(R)2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity.Reaffirmation. 

2–120 ................. ........................ ANSI/AAMI/ISO 10993–6:2007/(R)2010 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation.Reaffirmation. 

2–126 ................. ........................ ASTM F748–06 (Reapproved 2010) Standard Practice for Selecting 

Generic Biological Test Methods for Materials and Devices.

Reaffirmation. 

2–134 ................. ........................ ASTM F2065–00 (Reapproved 2010) Standard Practice for Testing for 

Alternative Pathway Complement Activation in Serum by Solid Materials.

Reaffirmation. 

2–155 ................. ........................ ASTM F2147–01 (Reapproved 2010) Standard Practice for Guinea 

Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens.

Reaffirmation. 

2–157 ................. 2–184 USP34–NF29:2011<87> Biological Reactivity Tests, In Vitro—Direct 

Contact Test.

Withdrawn and replaced with 

newer version. 

2–158 ................. 2–185 USP 34–NF29:2011 Biological Tests <87> Biological Reactivity Test, 

In Vitro—Elution Test.

Withdrawn and replaced with 

newer version. 

2–159 ................. 2–186 USP 34–NF29:2011 Biological Tests <88> Biological Reactivity Tests, 

In Vivo, Procedure Preparation of Sample.

Withdrawn and replaced with 

newer version. 

2–160 ................. 2–187 USP 34–NF29:2011 Biological Tests <88> Biological Reactivity Test, 

In Vitro, Classification of Plastics—Intracutaneous Test.

Withdrawn and replaced with 

newer version. 

2–161 ................. 2–188 USP 34–NF29:2011 Biological Tests <88> Biological Reactivity Tests, 

In Vivo Classification of Plastics—Systemic Injection Test.

Withdrawn and replaced with 

newer version. 

2–165 ................. ........................ ANSI/AAMI/ISO 10993–14:2001 (Reapproved 2006) Biological evaluation of medical devices—Part 14: Identification and quantification of 

degradation products from ceramics.

Reaffirmation. 

2–166 ................. 2–180 ANSI/AAMI/ISO 10993–16:2010 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products 

and leachables.

Withdrawn and replaced with 

newer version. 

C. Cardiovascular 

3–52 ................... ........................ ANSI/AAMI EC12:2000/(R)2010 Disposable ECG electrodes ............... Reaffirmation. 

3–61 ................... 3–95 IEC 60601–2–27 Edition 3.0 2011–03 Medical electrical equipment— 

Part 2–27: Particular requirements for the basic safety and essential 

performance of electrocardiographic monitoring equipment.

Newer version with transition period. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15768 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

D. Dental/ENT 

4–76 ................... ........................ ISO 7785–2 Second edition 1995–08–01 Dental handpieces—Part 2: 

Straight and geared angle handpieces.

Contact person. 

4–83 ................... ........................ ISO 11498 First edition 1997–02–15 Dental handpieces—Dental lowvoltage electrical motors.Contact person. 

4–84 ................... ........................ ISO 13294 First edition 1997–05–01 Dental handpieces—Dental airmotors.Contact person. 

4–90 ................... ........................ ANSI S3.39 Reaffirmed by ANSI May 18, 2007 Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance 

(Aural Acoustic Immittance).

Contact person. 

4–119 ................. ........................ ANSI/ADA Specification No. 82–1998 (R2009) Reversible/Irreversible 

Hydrocolloid Impression Material Systems.

Reaffirmation. 

4–121 ................. ........................ ISO 7494–2 First edition 2003–03–01 Dentistry—Dental units—Part 2: 

Water and air supply.

Contact person. 

4–123 ................. ........................ ANSI/ASA S3.6–2004 Specification for Audiometers ............................ Contact person. 

4–126 ................. ........................ ISO 10477 Second edition 2004–10–01 Dentistry—Polymer-based 

crown and bridge materials.

Contact person. 

4–134 ................. ........................ ISO 7494–1 First edition 2004–08–15 Dentistry—Dental units—Part 1: 

General requirements and test methods.

Contact person. 

4–136 ................. ........................ ASTM Designation: F2504–05 Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices.Contact person. 

4–150 ................. ........................ ANSI/ADA Specification No. 19–2003 Dental Elastometric Impression 

Material:2003.

Contact person. 

4–154 ................. ........................ ISO 4823 Third edition 2000–12–15 Dentistry—Elastometric impression materials.Contact person. 

4–155 ................. ........................ ISO 4823:2000 Technical Corrigendum 1 Published 2004–07–15 Dentistry—Elastomeric impression materials.Contact person. 

4–156 ................. ........................ ISO 4823 Third edition 2000–12–15 Amendment 1 2007–07–01 Dentistry—Elastometric impression materials.Contact person. 

4–160 ................. ........................ ANSI S3.1–1999 (Reaffirmed by ANSI October 28, 2008) American 

National Standard Maximum Permissible Ambient Noise Levels for 

Audiometric Test Rooms.

Contact person. 

4–162 ................. ........................ ANSI S3.4–2007 American National Standard Procedure for the Computation of Loudness of Steady Sounds.Contact person. 

4–163 ................. ........................ ANSI S3.5–1997 (R1986) Reaffirmed by ANSI May 18, 2007 American National Standard Methods for Calculation of the Speech Intelligibility Index.Contact person. 

4–164 ................. ........................ ANSI S3.7–1995 (Reaffirmed by ANSI October 28, 2008) American 

National Standard Method for Coupler Calibration of Earphones.

Contact person. 

4–165 ................. ........................ ANSI S3.13–1987 Reaffirmed by ANSI June 1, 2007 American National Standard Mechanical Coupler for Measurement of Bone Vibrators.Contact person. 

4–170 ................. ........................ ANSI S3.36–1985 Reaffirmed by ANSI on 4/27/2006 American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements.Contact person. 

4–171 ................. ........................ ANSI S3.37–1987 (Reaffirmed by ANSI May 18, 2007) American National Standard Preferred Earhook Nozzle Thread for Postauricular 

Hearing Aids.

Contact person. 

4–172 ................. ........................ ANSI S3.42–1992 Reaffirmed by ANSI May 18, 2007 American National Standard Testing Hearing Aids with a Broad-Band Noise Signal.Contact person. 

4–173 ................. ........................ ANSI S3.44–1996 Reaffirmed by ANSI on 27 April 2006 American 

National Standard Determination of Occupational Noise Exposure 

and Estimation of Noise-Induced Hearing Impairment.

Contact person. 

4–175 ................. ........................ ANSI S3.46–1997 American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids.Contact person. 

4–177 ................. ........................ ANSI S12.65–2006 (Reaffirmed by ANSI March 30, 2011) American 

National Standard For Rating Noise with Respect to Speech Interference.

Reaffirmation. 

4–179 ................. ........................ ISO 7405 Second edition 2008–12–15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistry.Contact person. 

4–180 ................. ........................ ISO 9168 Third edition 2009–07–15 Dentistry—Hose connectors for 

air driven dental handpieces.

Contact person. 

4–183 ................. ........................ ANSI S3.2–2009 American National Standard Method for Measuring 

the Intelligibility of Speech over Communication Systems.

Contact person. 

4–184 ................. ........................ ANSI/ASA S3.25–2009 American National Standard For an Occluded 

Ear Simulator.

Contact person. 

4–185 ................. ........................ ANSI/ASA S3.45–2009 American National Standard Procedures for 

Testing Basic Vestibular Function.

Contact person. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15769 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

4–186 ................. ........................ ANSI/ASA S12.2–2008 American National Standard Criteria for Evaluating Room Noise.Contact person. 

4–190 ................. ........................ ANSI/ASA S3.35–2010 American National Standard Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions.Contact person. 

4–192 ................. ........................ ANSI/ADA Specification No. 58–2010 Root Canal Files Type H 

(Hedstrom): 2007.

Contact person. 

E. General 

5–29 ................... ........................ AAMI/ANSI HE74–2001 (R 2009) Human factors design process for 

medical devices.

Withdrawn, see 5–67. 

5–39 ................... ........................ IEC 60812 Second edition 2006–01 Analysis techniques for system 

reliability—Procedure for failure mode and effects analysis (FMEA).

Contact person. 

5–40 ................... ........................ ISO 14971 Second edition 2007–03–01 Medical devices—Application 

of risk management to medical devices.

Contact person. 

5–42 ................... ........................ ASTM D903–98 (Reapproved 2010) Standard Test Methods for Peel 

or Stripping Strength of Adhesive Bonds.

Reaffirmation. 

5–58 ................... ........................ IEC 60601–1–11 Edition 1.0:2010 Medical electrical equipment—Part 

1–11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical 

equipment and medical electrical systems used in the home 

healthcare environment.

Extent of recognition and relevant 

guidance. 

F. General Hospital/General Plastic Surgery 

6–117 ................. ........................ ASTM F2172–02(2011) Standard Specification for Blood/Intravenous 

Fluid/Irrigation Fluid Warmers.

Reaffirmation and Contact person. 

6–161 ................. ........................ ISO 10555–1 First edition 1995–06–15 Sterile, Single-use 

intravascular catheters—Part 1: General requirements.

Title and Contact person. 

6–164 ................. ........................ ISO 10555–5 First edition 1996–06–15 Sterile, single-use 

intravascular catheters—Part 5: Over-needle peripheral catheters.

Title and Contact person. 

6–164 ................. 6–266 ISO 10555–5 First edition 1996–06–15 AMENDMENT 1 1999–01–15 

Corrected and reprinted 1999–07–15 Sterile, single-use 

intravascular catheters—Part 5: Over-needle peripheral catheters.

See 6–164. 

6–164 ................. 6–267 ISO 10555–5:1996 TECHNICAL CORRIGENDUM 1 Published 2002– 

06–15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters TECHNICAL CORRIGENDUM.

See 6–164. 

6–176 ................. ........................ ASTM D7103–06 1 Standard Guide for Assessment of Medical Gloves Editorial change. 

6–177 ................. ........................ ASTM E1112–00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature.Reaffirmation. 

6–198 ................. 6–254 ASTM F2100–11, Standard Specification for Performance of Materials 

Used in Medical Face Masks.

Withdrawn and replaced with 

newer version. 

6–203 ................. ........................ ASTM D6499–07, Standard Test Method for The Immunological 

Measurement of Antigenic Protein in Natural Rubber and its Products.

Extent of recognition. 

6–219 ................. 6–255 USP 34–NF 29<11>:2011 Sodium Chloride Irrigation ........................... Withdrawn and replaced with 

newer version. 

6–226 ................. 6–256 USP 34–NF 29<11>:2011 Sodium Chloride Injection ........................... Withdrawn and replaced with 

newer version. 

6–246 ................. 6–257 USP 34–NF 29 2011 Nonabsorbable Surgical Suture .......................... Withdrawn and replaced with 

newer version. 

6–248 ................. 6–258 USP 34–NF 29 2011 <881> Tensile Strength ....................................... Withdrawn and replaced with 

newer version. 

6–249 ................. 6–259 USP 34–NF 29 2011 <861> Sutures Diameter ..................................... Withdrawn and replaced with 

newer version. 

6–250 ................. 6–260 USP 34–NF 29 2011 <871> Sutures—Needle ...................................... Withdrawn and replaced with 

newer version. 

6–251 ................. 6–261 USP 34–NF 29 <11>:2011 Sterile Water for Irrigation .......................... Withdrawn and replaced with 

newer version. 

6–252 ................. 6–262 USP 34–NF 29 <11>:2011 Heparin Lock Flush Solution ...................... Withdrawn and replaced with

newer version. 

G. In Vitro Diagnostics 

7–102 ................. 7–221 CLSI H01–A6 Tubes and Additives for Venous and Capillary Blood 

Specimen Collection; Approved Standard—Sixth Edition.

Withdrawn and replaced with 

newer version. 

7–112 ................. ........................ CLSI H49–A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline.Withdrawn duplicate, see 7–162. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15770 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

7–126 ................. 7–222 CLSI M24–A2 Susceptibility Testing of Mycobacteria, Nocardiae, and 

Other Aerobic Actinomycetes; Approved Standards—Second Edition.

Withdrawn and replaced with 

newer version Contact person. 

7–128 ................. ........................ CLSI EP14–A2 Evaluation of Matrix Effects; Approved Guideline— 

Second Edition.

Withdrawn duplicate, see 7–143. 

7–130 ................. ........................ CLSI H20–A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition.Withdrawn duplicate, see 7–165. 

7–134 ................. ........................ CLSI GP20–A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; 

Approved Guideline—Second Edition.

Withdrawn duplicate, see 7–166. 

7–140 ................. 7–223 GP22–A3—Quality Management System: Continual Improvement; Approved Guideline—Third Edition.Withdrawn and replaced with 

newer version. 

7–143 ................. ........................ CLSI EP14–A2 Evaluation of Matrix Effects; Approved Guideline— 

Second Edition.

Contact person, Type of standard, 

Processes impacted. 

7–147 ................. ........................ CLSI M22–A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition.Withdrawn duplicate, see 7–178. 

7–150 ................. ........................ CLSI H43–A2 Clinical Flow Cytometric Analysis of Neoplastic 

Hematolymphoid Cells; Approved Guideline—Second Edition.

Title, Contact person. 

7–162 ................. ........................ CLSI H49–A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline.Contact person, Devices affected, 

Processes affected, Type of 

standard, CFR citation and product codes. 

7–165 ................. ........................ CLSI H20–A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition.Contact person, Devices affected, 

Processes affected, Type of 

standard, CFR citation and product codes. 

7–166 ................. ........................ CLSI GP20–A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; 

Approved Guideline—Second Edition.

Devices affected, Process affected, CFR citation and product 

codes. 

7–169 ................. ........................ CLSI M27–A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition.Withdrawn duplicate, see 7–204. 

7–172 ................. ........................ CLSI C28–A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition.Withdrawn duplicate, see 7–224. 

7–202 ................. 7–224 CLSI C28–A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition.Withdrawn and replaced with 

newer version. 

7–178 ................. ........................ CLSI M22–A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition.Extent of recognition, CFR citation 

and product codes. 

7–204 ................. ........................ CLSI M27–A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition.Contact person. 

7–206 ................. ........................ CLSI I/LA 20–A2 Analytical Performance Characteristics and Clinical 

Utility of Immunological Assays for Human Immunoglobulin E (IgE) 

Antibodies and Defined Allergen Specificities; Approved Guideline— 

Second Edition.

Title, Contact person. 

H. Materials 

11–219 ............... 8–203 ASTM F2026–08 Standard Specification for Polyetheretherketone 

(PEEK) Polymers for Surgical Implant Applications.

Transferred. 

8–101 ................. 8–204 ASTM F2118–10 Standard Test Method for Constant Amplitude of 

Force Controlled Fatigue Testing of Acrylic Bone Cement Materials.

Withdrawn and replaced with 

newer version. 

8–105 ................. 8–205 ASTM F1635–11 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated 

Forms for Surgical Implants.

Withdrawn and replaced with 

newer version. 

8–114 ................. ........................ ASTM F2255–05 (Reapproved 2010) Standard Test Method for 

Strength Properties of Tissue Adhesives in Lap-Shear by Tension 

Loading.

Reaffirmation. 

8–115 ................. ........................ ASTM F2256–05 (Reapproved 2010) Standard Test Method for 

Strength Properties of Tissue Adhesives in T-Peel by Tension 

Loading.

Reaffirmation. 

8–116 ................. ........................ ASTM F2258–05 (Reapproved 2010) Standard Test Method for 

Strength Properties of Tissue Adhesives in Tension.

Reaffirmation. 

8–119 ................. 8–206 ASTM F688–10 Standard Specification for Wrought Cobalt-35 Nickel20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035).Withdrawn and replaced with 

newer version. 

8–121 ................. ........................ ASTM F2005–05 (Reapproved 2010) Standard Terminology for Nickel-Titanium Shape Memory Alloys.Reaffirmation. 

8–125 ................. ........................ ASTM F2004–05 (Reapproved 2010) Standard Test Method for 

Transformation Temperature of Nickel-Titanium Alloys by Thermal 

Analysis.

Reaffirmation. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15771 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

8–126 ................. ........................ ASTM F561–05a (Reapproved 2010) Standard Practice for Retrieval 

and Analysis of Medical Devices, and Associated Tissues and 

Fluids.

Reaffirmation. 

8–132 ................. ........................ ASTM F1088–04a (Reapproved 2010) Standard Specification for 

Beta-Tricalcium Phosphate for Surgical Implantation.

Reaffirmation and contact person. 

8–135 ................. ........................ ASTM F2392–04 (Reapproved 2010) Standard Test Method for Burst 

Strength of Surgical Sealants.

Reaffirmation. 

8–136 ................. ........................ ASTM F2458–05 (Reapproved 2010) Standard Test Method for 

Wound Closure Strength of Tissue Adhesives and Sealants.

Reaffirmation. 

8–172 ................. 8–207 ASTM F1926/F1926M–10 Standard Test Method for Evaluation of the 

Environmental Stability of Calcium Phosphate Granules, Fabricated 

Forms, and Coatings.

Withdrawn and replaced with 

newer version. 

8–178 ................. 8–208 ASTM F648–10a Standard Specification for Ultra-High-MolecularWeight Polyethylene Powder and Fabricated Form for Surgical Implants.Withdrawn and replaced with 

newer version. 

8–181 ................. 8–209 ASTM F899–11 Standard Specification for Wrought Stainless Steels 

for Surgical Instruments.

Withdrawn and replaced with 

newer version. 

8–191 ................. 8–210 ASTM F2182–11 Standard Test Method for Measurement of Radio 

Frequency Induced Heating On or Near Passive Implants During 

Magnetic Resonance Imaging.

Withdrawn and replaced with 

newer version. 

8–195 ................. ........................ ASTM F2024–10, Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings.Extent of Recognition, devices affected, CFR citations and associated procodes and contact person. 

I. Neurology 

17–1 ................... ........................ ANSI/AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring devices.Reaffirmation. 

17–3 ................... ........................ ISO 7197:2006 Third edition 2006–06–01 Neurosurgical implants— 

Sterile, single-use hydrocephalus shunts and components.

Contact person. 

17–4 ................... ........................ ASTM F 647–94 (Reapproved 2006) Standard Practice for Evaluating 

and Specifying Implantable Shunt Assemblies for Neurosurgical Application.

Contact person. 

17–7 ................... ........................ ISO 7197:2006 Technical Corrigendum 1 Published:2007–07–01 Neurological implants—Sterile, single-use hydrocephalus shunts and 

components.

Contact person. 

J. OB–GYN/Gastroenterology 

9–21 ................... ........................ ISO 8600–4 First edition 1997–07–01 Optics and optical instruments—Medical endoscopes and certain accessories—Part 4: Determination of maximum width of insertion portion.Contact person. 

9–37 ................... ........................ ISO 8600–1 Second edition 2005–05–01 Optics and photonics—Medical endoscopes and endotherapy devices—Part 1: General requirements.Contact person. 

9–38 ................... ........................ ISO 8600–3 First edition 1997–07–01 AMENDMENT 1 2003–12–01 

Optics and optical instruments—Medical endoscopes and 

endoscopic accessories Part 3: Determination of field of view and 

direction of view of endoscopes with optics.

Contact person. 

9–39 ................... ........................ ISO 8600–5 First edition 2005–03–15 Optics and photonics—Medical 

endoscopes and endotherapy devices—Part 5: Determination of optical resolution of rigid endoscopes with optics.

Contact person. 

9–40 ................... ........................ ISO 8600–6 First edition 2005–03–15 Optics and photonics—Medical 

endoscopes and endotherapy devices—Part 6: Vocabulary.

Contact person. 

9–44 ................... ........................ ASTM Designation: F 623–99 (Reapproved 2006) Standard Performance Specification for Foley Catheter.Contact person. 

9–49 ................... ........................ AAMI/ANSI RD61:2006, Concentrates for hemodialysis ....................... Withdrawn, see 9–73. 

9–50 ................... ........................ ANSI/AAMI RD52:2004/(R)2010 Dialysate for Hemodialysis ................ Withdrawn, see 9–70 and 9–71. 

9–53 ................... ........................ ASTM F 1992–99 (Reapproved 2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments 

(EAI) Used with Flexible Endoscopes.

Contact person. 

9–55 ................... ........................ AAMI/ANSI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009, Water 

treatment equipment for hemodialysis applications.

Withdrawn, see 9–69. 

9–61 ................... ........................ IEC 60601–2–18 Edition 3.0 2009–08 Medical electrical equipment— 

Part 2–18: Particular requirements for the basic safety and essential 

performance of endoscopic equipment.

Contact person. 

9–59 ................... ........................ AAMI/ANSI RD5:2003/(R)2008, Hemodialysis ....................................... Withdrawn, see 9–72. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15772 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

K. Ophthalmic 

10–15 ................. ........................ ISO 9394 Second edition 1998–08–15 Ophthalmic optics—Contact 

lenses and contact lens care products—Determination of biocompatibility by ocular study using rabbit eyes.

Contact person. 

10–24 ................. 10–67 ISO 11986 Second edition 2010–11–01 Ophthalmic optics—Contact 

lenses and contact lens care products—Determination of preservative uptake and release.

Withdrawn and replaced with 

newer version. 

10–26 ................. 10–68 ISO 13212 Second edition 2011–05–15 Ophthalmic optics—Contact 

lens care products—Guidelines for determination of shelf-life.

Withdrawn and replaced with 

newer version. 

10–28 ................. ........................ ISO 14729 First edition 2001–04–15 Ophthalmic optics—Contact lens 

care products—Microbiological requirements and test methods for 

products and regimens for hygienic management of contact lenses.

Contact person. 

10–29 ................. ........................ ISO 14730 First edition 2000–09–15 Ophthalmic optics—Contact lens 

care products—Antimicrobial preservative efficacy testing and guidance on determining discard date.

Contact person. 

10–33 ................. 10–69 ANSI Z80.18–2010 for Ophthalmics—Contact Lens Care Products— 

Vocabulary, Performance Specifications, and Test Methodology.

Withdrawn and replaced with 

newer version. 

10–38 ................. 10–70 ISO 10943 Third edition 2011–08–15 Ophthalmic instruments—Indirect ophthalmoscopes.Withdrawn and replaced with 

newer version. 

10–59 ................. ........................ ISO 11980 Second edition 2009–10–15 Ophthalmic optics—Contact 

lenses and contact lens care products—Guidance for clinical investigations.

Contact person. 

L. Orthopedic 

11–167 ............... 11–226 ASTM F1089–10 Standard Test Method for Corrosion of Surgical Instruments.Withdrawn and replaced with 

newer version. 

11–180 ............... 11–227 ASTM F366–10 Standard Specification for Fixation Pins and Wires .... Withdrawn and replaced with 

newer version; change contact. 

11–196 ............... ........................ ASTM F1672–95 (Reapproved 2011) Standard Specification for Resurfacing Patellar Prosthesis.Reaffirmation. 

11–201 ............... 11–228 ASTM F564–10 Standard Specification and Test Methods for Metallic 

Bone Staples.

Withdrawn and replaced with 

newer version. 

11–217 ............... 11–229 ASTM F2083–10 Standard Specification for Total Knee Prosthesis ..... Withdrawn and replaced with 

newer version. 

11–221 ............... 11–230 ASTM F1717–10 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.Withdrawn and replaced with 

newer version. 

11–155 ............... 11–231 ISO 7207–2 Second edition 2011–07–01 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materials.Withdrawn and replaced with 

newer version. 

11–219 ............... 8–203 ASTM F2026–10 Standard Specification for Polyetheretherketone 

(PEEK) Polymers for Surgical Implant Applications.

Transferred and replaced with a 

newer version. 

M. Radiology 

12–52 ................. ........................ UL 544 (1998), Standard for Medical and Dental Equipment—Ed. 4.0 Withdrawn, see 5–4 and 5–52. 

12–62 ................. ........................ UL 187 (1998), Standard for X-ray Equipment—Ed. 7.0 ....................... Withdrawn, see 5–4 and 5–52. 

12–100 ............... ........................ NEMA UD 3–2004 (R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic 

Ultrasound Equipment, Revision 2.

Reaffirmation. 

12–105 ............... ........................ NEMA UD 2–2004 (R2009), Acoustic Output Measurement Standard 

for Diagnostic Ultrasound Equipment, Revision 3.

Reaffirmation. 

12–106 ............... ........................ ISO 17526 First edition 2003–06–15, Optics and optical instruments— 

Lasers and laser-related equipment—Lifetime of lasers.

Contact person. 

12–108 ............... 12–246 ISO 21254–2 First edition 2011–07–15 Lasers and laser-related 

equipment—Test methods for laser-induced damage threshold— 

Part 2: Threshold determination.

Withdrawn and replaced with 

newer version. 

12–109 ............... 12–245 ISO 21254–1 First edition 2011–07–15 Lasers and laser-related 

equipment—Test methods for laser-induced damage threshold— 

Part 1: Definitions and general principles.

Withdrawn and replaced with 

newer version. 

12–110 ............... ........................ ISO 11551 Second edition 2003–12–01, Optics and optical instruments—Lasers and laser-related equipment—Test method for absorptance of optical laser components.Contact person. 

12–113 ............... ........................ ISO 12005 Second edition 2003–04–01, Lasers and laser-related 

equipment—Test methods for laser beam parameters—Polarization.

Contact person. 

12–115 ............... ........................ ISO 13695 First edition 2004–06–01, Optics and photonics—Lasers 

and laser-related equipment—Test methods for the spectral characteristics of lasers.

Contact person. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15773 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

12–117 ............... ........................ ISO 15367–1 First edition 2003–09–15, Lasers and laser-related 

equipment—Test methods for determination of the shape of a laser 

beam wavefront—Part 1: Terminology and fundamental aspects.

Contact person. 

12–134 ............... ........................ ISO 11146–1 First edition 2005–01–15, Lasers and laser-related 

equipment—Test methods for laser beam widths, divergence angles 

and beam propagation ratios—Part 1: Stigmatic and simple astigmatic beams.

Contact person. 

12–140 ............... ........................ AIUM RTD2–2004, Standard for Real-Time Display of Thermal and 

Mechanical Acoustic Output Indices on Diagnostic Ultrasound 

Equipment Revision 2.

Title. 

12–142 ............... ........................ ISO 11146–2 First edition 2005–02–15, Lasers and laser-related 

equipment—Test methods for laser beam widths, divergence angles 

and beam propagation ratios—Part 2: General astigmatic beams.

Contact person. 

12–143 ............... ........................ ISO 15367–2 First edition 2005–03–15, Lasers and laser-related 

equipment—Test methods for determination of the shape of a laser 

beam wavefront—Part 2: Shack-Hartman sensors.

Contact person. 

12–144 ............... 12–247 ISO 11990–1 First edition 2011–08–01 Lasers and laser-related 

equipment—Determination of laser resistance of tracheal tubes— 

Part 1: Tracheal tube shaft.

Withdrawn and replaced with 

newer version. 

12–154 ............... 12–248 ISO 21254–3 First edition 2011–07–15 Lasers and laser-related 

equipment—Test methods for laser-induced damage threshold— 

Part 3: Assurance of laser power (energy) handling capabilities.

Withdrawn and replaced with 

newer version. 

12–155 ............... ........................ ISO 11554 Third edition 2006–05–01, Optics and photonics—Lasers 

and laser-related equipment—Test methods for laser beam power, 

energy and temporal characteristics.

Contact person. 

12–156 ............... ........................ ISO 11670:2003 Technical Corrigendum 1 Published 2004–05–15, 

Lasers and laser-related equipment—Test methods for laser beam 

parameters—Beam positional stability.

Contact person. 

12–157 ............... ........................ ISO 13694:2000 Technical Corrigendum 1 Published 2005–11–01, 

Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distribution.

Contact person. 

12–174 ............... ........................ ISO 13697 First edition 2006–05–15, Optics and photonics—Lasers 

and laser-related equipment—Test methods for specular reflectance 

and regular transmittance of optical laser components.

Contact person. 

12–175 ............... ........................ ISO 24013 First edition 2006–11–15, Optics and photonics—Lasers 

and laser-related equipment—Measurement of phase retardation of 

optical components for polarized laser radiation.

Contact person. 

12–177 ............... 12–249 ANSI/UL 122–2007 Standard for Photographic Equipment—Ed. 5.0 ... Withdrawn and replaced with 

newer version. 

12–125 ............... 12–231 NEMA MS 5–2010, Determination of Slice Thickness in Diagnostic 

Magnetic Resonance Imaging.

Withdrawn and replaced with 

newer version. 

12–151 ............... 12–232 NEMA MS 4–2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices.Withdrawn and replaced with 

newer version. 

12–160 ............... 12–234 NEMA MS 12–2010, Quantification and Mapping of Geometric Distortion for Special Applications.Withdrawn and replaced with 

newer version. 

12–162 ............... 12–235 IEC 60731 Edition 3.0 2011–02, Amendment 1, Medical electrical 

equipment—Dosimeters with ionization chambers as used in radiotherapy.

Withdrawn and replaced with 

newer version. 

12–178 ............... 12–236 IEC 60601–2–45 Edition 3.0 2011–02, Medical electrical equipment— 

Part 2–45: Particular requirements for the basic safety and essential 

performance of mammographic X-ray equipment and mammographic stereotactic devices.

Newer version with transition period. 

12–191 ............... 12–237 IEC 62359 Edition 2.0 2010–10, Ultrasonics—Field characterization— 

Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields.

Withdrawn and replaced with 

newer version. 

12–218 ............... 12–238 NEMA PS 3.1–3.20 (2011), Digital Imaging and Communications in 

Medicine (DICOM) Set.

Withdrawn and replaced with 

newer version. 

N. Software/Informatics 

13–11 ................. 13–30 CLSI AUTO3–A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard, Second Edition 2009.Withdrawn and replaced with 

newer version. 

O. Sterility 

14–135 ............... ........................ AAMI/ANSI ST63:2002, Sterilization of health care products—Requirements for the development, validation and routine control of an industrial sterilization process for medical devices—Dry heat.Withdrawn, see 14–339. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15774 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

14–169 ............... ........................ ASTM F2391–05 (Reapproved 2011) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas.Reaffirmation. 

14–170 ............... 14–313 ASTM F2475–11 Standard Guide for Biocompatibility Evaluation of 

Medical Device Packaging Materials.

Withdrawn and replaced with 

newer version. 

14–181 ............... ........................ ANSI/AAMI ST58:2005/(R)2010 Chemical sterilization and high-level 

disinfection in health care facilities.

Reaffirmation and contact person. 

14–193 ............... ........................ ANSI/AAMI/ISO 11607–1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile 

barrier systems, and packaging systems.

Reaffirmation. 

14–194 ............... ........................ ANSI/AAMI/ISO 11607–2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, 

sealing, and assembly processes.

Reaffirmation. 

14–195 ............... ........................ ANSI/AAMI/ISO 11140–1:2005(R)2010 Sterilization of health care 

products—Chemical indicators—Part 1: General requirements.

Reaffirmation, extent of recognition, and type of standard. 

14–201 ............... ........................ ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable 

medical device sterilization.

Reaffirmation and contact person. 

14–214 ............... ........................ AOAC 6.2.04:2009 Official Method 955.15, Testing Disinfectants 

Against Staphylococcus aureus, Use—Dilution Method.

Reaffirmation. 

14–216 ............... ........................ AOAC 6.2.06:2009 Official Method 964.02, Testing Disinfectants 

Against Pseudomonas aeruginosa, Use—Dilution Method.

Reaffirmation. 

14–219 ............... ........................ AOAC 6.3.06:2008 Official Method 965.12, Tuberculocidal Activity of 

Disinfectants.

Reaffirmation. 

14–222 ............... ........................ ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care products—Biological and chemical indicators—Test equipment.Reaffirmation, and contact person. 

14–225 ............... ........................ ANSI/AAMI/ISO 11137–2:2006 Sterilization of health care products— 

Radiation—Part 2: Establishing the sterilization dose.

Extent of recognition and relevant 

guidance. 

14–227 ............... ........................ ANSI/AAMI/ISO 11737–1:2006 Sterilization of health care products— 

Microbiological methods—Part 1: Determination of the population of 

microorganisms on product.

Extent of recognition and title. 

14–228 ............... ........................ ANSI/AAMI/ISO 11135–1:2007 Sterilization of health care products— 

Ethylene oxide—Part 1: Requirements for development, validation, 

and routine control of a sterilization process for medical devices.

Extent of recognition. 

14–238 ............... ........................ ANSI/AAMI/ISO 11140–5:2007, Sterilization of health care products— 

Chemical indicators—Part 5: Class 2 indicators for Bowie and Dicktype air removal tests.

Relevant guidance. 

14–261 ............... ........................ ANSI/AAMI/ISO 17665–1:2006 Sterilization of health care products— 

Moist heat—Part 1: Requirements for the development, validation, 

and routine control of a sterilization process for medical devices.

Extent of recognition, relevant 

guidance and contact person. 

14–274 ............... ........................ ANSI/AAMI/ISO 15882:2008 Sterilization of health care products— 

Chemical indicators—Guidance for selection, use, and interpretation 

of results.

Extent of recognition. 

14–276 ............... 14–314 ANSI/AAMI ST67:2011 Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) 

for products labeled ‘‘sterile’’.

Withdrawn and replaced with 

newer version. 

14–285 ............... ........................ ANSI/AAMI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results.Title, contact person. 

14–287 ............... ........................ ANSI/AAMI/ISO 11737–2:2009 Sterilization of medical devices— 

Microbiological methods—Part 2: Tests of sterility performed in the 

definition, validation and maintenance of a sterilization process.

Extent of recognition and title. 

14–291 ............... ........................ ANSI/AAMI/ISO 14937:2009 Sterilization of health care products— 

General requirements for characterization of a sterilizing agent and 

the development, validation, and routine control of a sterilization 

process for medical devices.

Extent of recognition. 

14–295 ............... ........................ ANSI/AAMI ST81:2004/(R)2010, Sterilization of medical devices—Information to be provided by the manufacturer for the processing of 

resterilizable medical devices.

Relevant guidance and contact 

person. 

14–296 ............... ........................ ANSI/AAMI/ISO 11138–1:2006/(R)2010 Sterilization of health care 

products—Biological indicators—Part 1: General requirements.

Extent of recognition, contact person and relevant guidance. 

14–297 ............... ........................ ANSI/AAMI/ISO 11137–1:2006/(R)2010 Sterilization of health care 

products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.

Extent of recognition, and relevant 

guidance. 

14–298 ............... ........................ ANSI/AAMI/ISO 11137–3:2006/(R)2010 Sterilization of health care 

products—Radiation—Part 3: Guidance on dosimetric aspects.

Extent of recognition and relevant 

guidance. 

14–301 ............... 14–315 USP 34:2011 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests.Withdrawn and replaced with 

newer version. 

14–302 ............... 14–316 USP 34:2011 <71> Sterility Tests .......................................................... Withdrawn and replaced with 

newer version. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15775 

TABLE 2—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

14–303 ............... 14–317 USP 34:2011 <85> Bacterial Endotoxins Test ...................................... Withdrawn and replaced with 

newer version. 

14–304 ............... 14–318 USP 34:2011 <151> Pyrogen Test (USP Rabbit Test) ......................... Withdrawn and replaced with 

newer version. 

14–305 ............... 14–319 USP 34:2011 <161> Transfusion and Infusion Assemblies and Similar 

Medical Devices.

Withdrawn and replaced with 

newer version. 

14–306 ............... 14–320 USP 34:2011 Biological Indicator for Steam Sterilization—Self Contained.Withdrawn and replaced with 

newer version. 

14–307 ............... 14–321 USP 34:2011 Biological Indicator for Dry-Heat Sterilization, Paper 

Carrier.

Withdrawn and replaced with 

newer version. 

14–308 ............... 14–322 USP 34:2011 Biological Indicator for Ethylene Oxide Sterilization, 

Paper Carrier.

Withdrawn and replaced with 

newer version. 

14–309 ............... 14–323 USP 34:2011 Biological Indicator for Steam Sterilization, Paper Carrier.Withdrawn and replaced with 

newer version. 

14–310 ............... 14–324 USP 34:2011 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.Withdrawn and replaced with 

newer version. 

P. Tissue Engineering 

15–7 ................... 15–27 ASTM F2315–11 Standard Guide for Immobilization or Encapsulation 

of Living Cells or Tissue in Alginate Gels.

Withdrawn and replaced with 

newer version. 

15–8 ................... ........................ ASTM F2064–00 (Reapproved 2006) 1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for 

Use in Biomedical and Tissue-Engineered Medical Products Application.

Editorial change. 

15–10 ................. ........................ ASTM F2451–05 (Reapproved 2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate 

Articular Cartilage.

Reaffirmation. 

15–12 ................. 15–28 ASTM F2103–11 Standard Guide for Characterization and Testing of 

Chitosan Salts as Starting Materials Intended for Use in Biomedical 

and Tissue-Engineered Medical Product Applications.

Withdrawn and replaced with 

newer version. 

15–15 ................. 15–29 ASTM F2259–10 Standard Test Method for Determining the Chemical 

Composition and Sequence in Alginate by Proton Nuclear Magnetic 

Resonance (1H NMR) Spectroscopy.

Withdrawn and replaced with 

newer version. 

15–18 ................. 15–30 ASTM F2212–11 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for 

Tissue Engineered Medical Products (TEMPs).

Withdrawn and replaced with 

newer version. 

15–25 ................. 15–31 ASTM F2312–11 Standard Terminology Relating to Tissue Engineered Medical Products.Withdrawn and replaced with 

newer version. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

In table 3 of this document, FDA 

provides the listing of new entries and 

consensus standards added as 

modifications to the list of recognized 

standards under Recognition List 

Number: 028. 

TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition No. Title of standard 1 Reference 

Number and date 

A. Biocompatibility 

2–173 ........................... Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization ... ANSI/AAMI/ISO 

10993–10:2010. 

2–175 ........................... Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and 

reproductive toxicity.

ISO 10993–3 Second 

edition 2003–10–15. 

2–176 ........................... Biological evaluation of medical devices Part 11: Tests for systemic toxicity ............................ ISO 10993–11 Second 

edition 2006–08–15. 

2–177 ........................... Biological evaluation of medical devices—Part 6: Tests for local effects after implantation ..... ISO 10993–6 Second 

edition 2007–04–15. 

2–178 ........................... Biological evaluation of medical devices—Part 12: Sample preparation and reference materials.ISO 10993–12 Third 

edition 2007–11–15 

Corrected version 

2008–02–15. 

2–179 ........................... Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process.ISO 10993–1 Fourth 

edition 2009–10–15. 

2–181 ........................... Clinical investigation of medical devices for human subjects—Good clinical practice ............... ANSI/AAMI/ISO 

14155:2011. 

mstockstill on DSK4VPTVN1PROD with NOTICES

15776 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference 

Number and date 

2–182 ........................... Clinical investigation of medical devices for human subjects—Good clinical practice ............... ISO 14155 Second 

edition 2011–02–01. 

2–183 ........................... Clinical investigation of medical devices for human subjects—Good clinical practice TECHNICAL CORRIGENDUM 1.ISO 14155: 2011 

Technical Corrigendum 1 Published 

2011–07–15. 

B. Cardiovascular 

3–96 ............................. Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type.ISO 81060–1 First edition 2007–12–01. 

3–97 ............................. Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement 

type.

ISO 81060–2 First edition 2009–05–01. 

3–98 ............................. Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement 

type TECHNICAL CORRIGENDUM 1.

ISO 81060–2:2009 

TECHNICAL CORRIGENDUM 1 Published 2011–02–15. 

3–99 ............................. Evaluation of particulates associated with vascular medical devices ......................................... AAMI TIR42:2010. 

3–100 ........................... Medical electrical equipment—Part 2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment.ANSI/AAMI/IEC 

60601–2–27:2011. 

C. General 

5–68 ............................. Medical devices—Symbols to be used with medical device labels, labelling, and information 

to be supplied—Part 2: Symbol development, selection and validation.

ANSI/AAMI/ISO 

15223–2:2010. 

5–69 ............................. Medical electrical equipment—Part 1–11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and 

medical electrical systems used in the home healthcare environment Corrigendum 1.

IEC 60601–1–11 (First 

edition—2010) April 

2011. 

5–70 ............................. Medical devices—Application of risk management to medical devices ..................................... ANSI/AAMI/ISO 

14971:2007/(R)2010. 

D. General Hospital/General Plastic Surgery 

6–263 ........................... Absorbable Surgical Suture ......................................................................................................... USP 34–NF 28 2011. 

6–264 ........................... Sterile, single-use intravascular catheters—Part 1: General requirements ................................ ISO 10555–1 First edition 1995–06–15 

Amendment 1 1999– 

07–15. 

6–265 ........................... Sterile, single-use intravascular catheters—Part 1: General requirements ................................ ISO 10555–1 First edition 1995–06–15 

AMENDMENT 2 

2004–05–15. 

6–268 ........................... Standard Terminology Relating to Hemostatic Forceps ............................................................. ASTM F921—10 (Reapproved 2011). 

6–269 ........................... Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades ..................... ASTM F1078—10 (Reapproved 2011). 

6–270 ........................... Standard Terminology for Surgical Suture Needles ................................................................... ASTM F1840–10 1. 

6–271 ........................... Standard Test Method for Bend Testing of Needles Used in Surgical Sutures ......................... ASTM F1874—98 (Reapproved 2011). 

6–272 ........................... Standard Specification for Square Drive Interconnections on Surgical Instruments .................. ASTM F2062—00 (Reapproved 2011). 

6–273 ........................... Sharps injury protection—Requirements and test methods—Sharps protection features for 

single-use hypodermic needles, introducers for catheters and needles used for blood sampling.

ISO 23908 First edition 

2011–06–11. 

E. In Vitro Diagnostics 

7–225 ........................... Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; 

Approved Guideline.

CLSI GP34–A. 

7–226 ........................... Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth 

Edition.

CLSI GP26–A4. 

7–227 ........................... Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; 

Approved Guideline.

CLSI M53–A. 

F. Materials 

8–211 ........................... Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form ........... ISO 5834–1 Third edition 2005–06–01. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15777 

TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference 

Number and date 

8–212 ........................... Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form TECHNICAL CORRIGENDUM 1.ISO 5834–1:2005 

TECHNICAL CORRIGENDUM 1 Published 2007–05–01. 

8–213 ........................... Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing 

methods.

ISO 5834–3 First edition 2005–07–15. 

8–214 ........................... Implants for surgery—Ultra-high molecular weight polyethylene—Part 4: Oxidation index 

measurement method.

ISO 5834–4 First edition 2005–05–01. 

8–215 ........................... Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment method.ISO 5834–5 First edition 2005–06–01. 

G. Neurology 

17–9 ............................. Implants for surgery—Active implantable medical devices Part 3: Implantable 

neurostimulators.

ANSI/AAMI/ISO 

14708–3:2008. 

H. OB–GYN/Gastroenterology 

9–69 ............................. Water for hemodialysis and related therapies ............................................................................ ANSI/AAMI/ISO 

13959:2009. 

9–70 ............................. Guidance for the preparation and quality management of fluids for hemodialysis and related 

therapies.

ANSI/AAMI/ISO 

23500:2011. 

9–71 ............................. Quality of dialysis fluid for hemodialysis and related therapies .................................................. ANSI/AAMI/ISO 

11663:2009. 

9–72 ............................. Medical electrical equipment, Part 2–16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment.ANSI/AAMI/IEC 

60601–2–16:2008. 

9–73 ............................. Concentrates for haemodialysis and related therapies ............................................................... ANSI/AAMI/ISO 

13958:2009. 

9–74 ............................. Concentrates for haemodialysis and related therapies ............................................................... ISO 13958 Second 

edition 2009–4–15. 

I. Ophthalmic 

10–71 ........................... Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses.ISO 14729 First edition 

2001–04–15 

AMENDMENT 1 

2010–10–01. 

10–72 ........................... Ophthalmic instruments—Fundamental requirements and test methods—Part 1: General requirements applicable to all ophthalmic instruments.ISO 15004–1 First edition 200–606–01. 

J. Orthopedic 

11–232 ......................... Implants for surgery—Components for partial and total knee joint prostheses—Part 1: Classification, definitions and designation of dimensions.ISO 7207–1 Third edition 2007–02–01. 

11–233 ......................... Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation 

Devices.

ASTM F384—06 (Reapproved 2011). 

11–234 ......................... Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses.ASTM F732—00 (Reapproved 2011). 

K. Radiology 

12–233 ......................... Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability.ISO 11670 Second 

edition 2003–04–01. 

12–239 ......................... SAFETY OF LASER PRODUCTS—Part 1: Equipment classification and requirements, INTERPRETATION SHEET 1.IEC 60825–1 (Second 

edition—2007) I–SH 

01 December 2009. 

12–240 ......................... SAFETY OF LASER PRODUCTS—Part 1: Equipment classification and requirements, INTERPRETATION SHEET 2.IEC 60825–1 (2007), 

second edition/I–SH 

02 January 2011. 

12–241 ......................... Medical electrical equipment—Safety of radiotherapy record and verify systems ..................... IEC 62274 First edition 

2005–05. 

12–242 ......................... Medical electrical equipment—Part 2–57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.IEC 60601–2–57 Edition 1.0 2011–01. 

12–243 ......................... Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser 

beam power [energy] density distribution.

ISO 13694, First edition 2000–04–01. 

12–244 ......................... Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1.IEC 62359 (Second 

edition—2010). 

mstockstill on DSK4VPTVN1PROD with NOTICES

15778 Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 

TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference 

Number and date 

L. Sterility 

14–325 ......................... Sterilization of health care products—Vocabulary ...................................................................... ISO/TS 11139 Second 

edition 2006–01–15. 

14–326 ......................... Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products.ISO 11737–1 Second 

edition 2006–04–01. 

14–327 ......................... Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process.ISO 11737–2 Second 

edition 2009–11–15. 

14–328 ......................... Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.ISO 11137–1 First edition 2006–04–15. 

14–329 ......................... Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose .... ISO 11137–2 First edition 2006–04–15. 

14–330 ......................... Sterilization of health careproducts—Radiation—Part 3: Guidance on dosimetric aspects ....... ISO 11137–3 First edition 2006–04–15. 

14–331 ......................... Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.ISO 11135–1 First edition 2007–05–01. 

14–332 ......................... Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for 

Bowie and Dick-type air removal tests.

ISO 11140–5 Second 

edition 2007–03–15. 

14–333 ......................... Sterilization of health care products—Moist heat—Part 1: Requirements for the development, 

validation and routine control of a sterilization process for medical devices.

ISO 17665–1 First edition 2006–08–15. 

14–334 ......................... Sterilization of health care products—Chemical indicators—Guidance for selection, use and 

interpretation of results.

ISO 15882 Second 

edition 2008–09–01. 

14–335 ......................... Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals .......... ISO 10993–7 Second 

edition 2008–10–15. 

14–336 ......................... Sterilization of health care products—Biological indicators—Guidance for the selection, use 

and interpretation of results.

ISO 14161 Second 

edition 2009–09–15. 

14–337 ......................... Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process 

for medical devices.

ISO 14937 Second 

edition 2009–10–15. 

14–338 ......................... Sterilization of health care products—Biological indicators—Part 1: General requirements ...... ISO 11138–1 Second 

edition 2006–07–01. 

14–339 ......................... Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devices.ANSI/AAMI/ISO 

20857:2010. 

14–340 ......................... Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devices.ISO 20857 First edition 

2010–08–15. 

14–341 ......................... Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities ...................... ASTM E2303—11. 

14–342 ......................... Standard Practice for Dosimetry in Radiation Processing .......................................................... ASTM E2628—09 1. 

14–343 ......................... Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for 

Use in Radiation Processing.

ASTM E2701—09. 

14–344 ......................... Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery ..... ASTM F2825—10 1. 

14–345 ......................... Standard guide for selection and calibration of dosimetry systems for radiation processing .... ISO/ASTM 51261 First 

edition 2002–03–15. 

14–346 ......................... Standard Practice for Use of a Polymethylmethacrylate Dosimetry System .............................. ISO/ASTM 51276 Second edition 2002– 

12–15. 

14–347 ......................... Standard Practice for Dosimetry in Gamma Irradiation Facilities for Radiation Processing ...... ISO/ASTM 51702 Second edition 2004– 

08–15. 

14–348 ......................... Aseptic processing of health care products—Part 2: Filtration ................................................... ANSI/AAMI/ISO 

13408–2:2003. 

14–349 ......................... Aseptic processing of health care products—Part 3: Lyophilization ........................................... ANSI/AAMI/ISO 

13408–3:2006. 

14–350 ......................... Aseptic processing of health care products—Part 4: Clean-in-place technologies .................... ANSI/AAMI/ISO 

13408–4:2005. 

14–351 ......................... Aseptic processing of health care products—Part 5: Sterilization in place ................................ ANSI/AAMI/ISO 

13408–5:2006. 

14–352 ......................... Aseptic processing of health care products—Part 6: Isolator systems ...................................... ANSI/AAMI/ISO 

13408–6:2005. 

14–353 ......................... Sterilization of health care products—Chemical indicators—Part 1: General requirements ...... ISO 11140–1 Second 

edition 2005–07–15. 

14–354 ......................... Sterilization of health care products—Biological and chemical indicators—Test equipment ..... ISO 18472 First edition 

2006–06–01. 

14–355 ......................... Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems.ISO 11607–1 First edition 2006–04–15. 

14–356 ......................... Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes.ISO 11607–2 First edition 2006–04–15. 

14–357 ......................... Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products.ISO 11737–1:2006 

TECHNICAL CORRIGENDUM 1 Published 2007–05–15. 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 77, No. 52 / Friday, March 16, 2012 / Notices 15779 

TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of standard 1 Reference 

Number and date 

M. Tissue Engineering 

15–32 ........................... Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton 

Nuclear Magnetic Resonance (1 H NMR) Spectroscopy.

ASTM F2260–03 (Reapproved 2008). 

15–33 ........................... Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by 

Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC–MALS).

ASTM F2602–08 1. 

15–34 ........................... Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion 

Chromatography with Multi-angle Light Scattering Detection (SEC–MALS).

ASTM F2605–08 1. 

15–35 ........................... Standard Guide for Characterization of Hydrogels used in Regenerative Medicine .................. ASTM F2900–11. 

15–36 ........................... Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs).ASTM F2383–11. 

1All standard titles in this table conform to the style requirements of the respective organizations. 

IV. List of Recognized Standards 

FDA maintains the Agency’s current 

list of FDA recognized consensus 

standards in a searchable database that 

may be accessed directly at FDA’s 

Internet site at http:// 

www.accessdata.fda.gov/scripts/cdrh/ 

cfdocs/cfStandards/search.cfm. FDA 

will incorporate the modifications and 

minor revisions described in this notice 

into the database and, upon publication 

in the Federal Register, this recognition 

of consensus standards will be effective. 

FDA will announce additional 

modifications and minor revisions to 

the list of recognized consensus 

standards, as needed, in the Federal 

Register once a year, or more often, if 

necessary. 

V. Recommendation of Standards for 

Recognition by FDA 

Any person may recommend 

consensus standards as candidates for 

recognition under the new provision of 

section 514 of the FD&C Act by 

submitting such recommendations, with 

reasons for the recommendation, to the 

contact person (see FOR FURTHER

INFORMATION CONTACT). To be properly 

considered, such recommendations 

should contain, at a minimum, the 

following information: (1) Title of the 

standard; (2) any reference number and 

date; (3) name and address of the 

national or international standards 

development organization; (4) a 

proposed list of devices for which a 

declaration of conformity to this 

standard should routinely apply; and (5) 

a brief identification of the testing or 

performance or other characteristics of 

the device(s) that would be addressed 

by a declaration of conformity. 

VI. Electronic Access 

You may obtain a copy of ‘‘Guidance 

on the Recognition and Use of 

Consensus Standards’’ by using the 

Internet. CDRH maintains a site on the 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards-related 

documents. After publication in the 

Federal Register, this notice 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 028’’ will be available on the 

CDRH home page. You may access the 

CDRH home page at http://www.fda.gov/ 

MedicalDevices. 

You may access ‘‘Guidance on the 

Recognition and Use of Consensus 

Standards,’’ and the searchable database 

for ‘‘FDA Recognized Consensus 

Standards’’ at http://www.fda.gov/ 

MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/ 

Standards/ucm123792.htm. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) either electronic 

or written comments regarding this 

document. It is only necessary to send 

one set of comments. Identify comments 

with the docket number found in 

brackets in the heading of this 

document. FDA will consider any 

comments received in determining 

whether to amend the current listing of 

modifications to the list of recognized 

standards, Recognition List Number: 

028. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: March 12, 2012. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2012–6389 Filed 3–15–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2011–M–0735, FDA– 

2011–M–0736, FDA–2011–M–0737, FDA– 

2011–M–0746, FDA–2011–M–0786, FDA– 

2011–M–0791, FDA–2011–M–0792, FDA– 

2011–M–0796, FDA–2011–M–0832, FDA– 

2011–M–0837, FDA–2011–M–0848, FDA– 

2011–M–0865, FDA–2011–M–0866, FDA– 

2011–M–0910, and FDA–2011–M–0917] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

Agency’s Division of Dockets 

Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

mstockstill on DSK4VPTVN1PROD with NOTICES