Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451; formerly Docket No. 2004N-0226]

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 040

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: 040” (Recognition List Number: 040), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit electronic or written comments concerning this document at any time. See section VII for the effective date of the recognition of standards announced in this document.

ADDRESSES:

An electronic copy of Recognition List Number: 040 is available on the Internet at

http://

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

See section VI for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 040 modifications and other standards related information.

Submit written requests for a single hard copy of the document entitled “Modifications to the List of Recognized Standards, Recognition List Number: 040” to the Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8149.

Submit electronic comments on this document to

http://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-6287,

standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (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

, can be accessed at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains HTML and PDF versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency's Internet site. See section VI 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: 040

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions 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: 040” to identify these current modifications.

In table 1, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable; (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, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.

Table 1—Modifications to the List of Recognized Standards

Old recognition No.

Replacement recognition No.

Title of standard

1

Change

A. Anesthesia

1-46

1-103

ISO 5367 Fifth edition 2014-10-15 Anaesthetic and respiratory equipment—Breathing sets and connectors

Withdrawn and replaced with newer version.

1-82

IEC 60601-2-13 Edition 3.1 2009-08, Medical electrical equipment—Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems

Withdrawn. See 1-104.

B. Biocompatibility

2-179

2-220

ISO 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices—Part 1:

Evaluation and Testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

Withdrawn and replaced with newer version including Technical Corrigendum.

2-208

2-215

USP 38-NF33:2015 <87> Biological Reactivity Test, In Vitro—Direct Contact Test

Withdrawn and replaced with newer version.

2-209

2-216

USP 38-NF33:2015 <87> Biological Reactivity Test, In Vitro—Elution Test

Withdrawn and replaced with newer version.

2-210

2-217

USP 38-NF33:2015 <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of Sample

Withdrawn and replaced with newer version.

2-211

2-218

USP 38-NF33:2015 <88> Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test

Withdrawn and replaced with newer version.

2-212

2-219

USP 38-NF33:2015 <88> Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test

Withdrawn and replaced with newer version.

C. Cardiovascular

3-76

ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine The Corrosion Susceptibility of Small Implant Devices

Transferred. See 8-177.

3-117

ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type

Extent of recognition.

3-122

ISO 81060-2 Second edition 2013-05-01 Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type

Extent of recognition.

D. Dental/Ear, Nose, and Throat (ENT)

4-105

ANSI/ADA Standard No.75 (Reaffirmed by ANSI: September 8, 2014) Resilient Lining Materials For Removable Dentures, Part 1: Short-Term Materials

Reaffirmation.

4-130

ANSI/ADA Standard No. 17 (Reaffirmed by ANSI: September 8, 2014) Denture Base Temporary Relining Resins

Reaffirmation.

4-150

ANSI/ADA Specification No. 19-2004/ISO 4823:2000 (Reaffirmed by ANSI: October 6, 2014) Dental Elastomeric Impression Materials

Reaffirmation.

4-184

ANSI/ASA S3.25-2009 (Revision of ANSI S3.25-1989) (Reaffirmed by ANSI September 11, 2014) American National Standard For an Occluded Ear Simulator

Reaffirmation.

4-191

4-220

ANSI/ASA S3.22-2014 AMERICAN NATIONAL STANDARD Specification of Hearing Aid Characteristics

Withdrawn and replaced with newer version.

E. General I (Quality Systems/Risk Management (QS/RM))

5-67

ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of usability engineering to medical devices

Withdrawn. See 5-96.

5-87

IEC 62366 Edition 1.1 2014-01 Medical devices—Application of usability engineering to medical devices

Withdrawn. See 5-95.

5-94

AAMI/CN20 (PS):2014 Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methods

Withdrawn. See 5-97.

F. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))

19-6

IEC 60601-1-11 Edition 1.0 2010-04 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 [Including: Technical Corrigendum 1 (2011)]

Transition Period Added.

G. General Hospital/General Plastic Surgery (GH/GPS)

6-110

ASTM F1441-03 (Reapproved 2014) Standard Specification for Soft-Tissue Expander Devices

Reaffirmation.

6-185

ASTM F881−94 (Reapproved 2014) Standard Specification for Silicone Elastomer Facial Implants

Reaffirmation.

6-200

ASTM E1061-01 (Reapproved 2014) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers

Reaffirmation.

6-274

6-341

ISO 11608-1 Third Edition 2014-12-15 Needle-based injection systems for medical use—Requirements and test methods—Part 1: Needle-based injection systems

Withdrawn and replaced with newer version.

6-301

ISO 10555-1 Second Edition 2013-07-01 Sterile, single-use intravascular catheters—Part 1: General requirements

Extent of Recognition.

6-308

6-342

IEC 80601-2-35 Edition 2.0 2009-10 Medical electrical equipment—Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Technical Corrigendum 1 (2012) and Technical Corrigendum 2 (2015)]

Withdrawn and replaced with newer version including Technical Corrigendum.

6-326

6-343

USP 38-NF 33:2015 Sodium Chloride Irrigation

Withdrawn and replaced with newer version.

6-327

6-344

USP 38-NF 33:2015 Sodium Chloride Injection

Withdrawn and replaced with newer version.

6-328

6-345

USP 38-NF33:2015 Nonabsorbable Surgical Suture

Withdrawn and replaced with newer version.

6-329

6-346

USP 38-NF33:2015 <881> Tensile Strength

Withdrawn and replaced with newer version.

6-330

6-347

USP 38-NF33:2015 <861> Sutures—Diameter

Withdrawn and replaced with newer version.

6-331

6-348

USP 38-NF33:2015 <871> Sutures—Needle Attachment

Withdrawn and replaced with newer version.

6-332

6-349

USP 38-NF33:2015 Sterile Water for Irrigation

Withdrawn and replaced with newer version.

6-333

6-350

USP 38-NF33:2015 Heparin Lock Flush Solution

Withdrawn and replaced with newer version.

6-334

6-351

USP 38-NF33:2015 Absorbable Surgical Suture

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-110

7-251

CLSI EP05-A3 Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Third Edition

Withdrawn and replaced with newer version.

7-143

7-252

CLSI EP14-A3 Evaluation of Matrix Effects; Approved Guideline—Third Edition

Withdrawn and replaced with newer version.

7-153

7-253

CLSI EP15-A3 User Verification of Performance for Precision and Estimation of Bias; Approved Guideline-Third Edition

Withdrawn and replaced with newer version.

7-230

7-254

CLSI M07-A10 Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard—Ninth Edition

Withdrawn and replaced with newer version.

7-123

7-255

CLSI MM09-A2 Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline—Second Edition

Withdrawn and replaced with newer version.

7-247

7-256

CLSI M100-S25 Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fifth Informational Supplement

Withdrawn and replaced with newer version.

I. Materials

8-59

8-386

ISO 5832-4 Third edition 2014-09-15 Implants for surgery—Metallic materials—Part 4: Cobalt-chromium-molybdenum casting alloy

Withdrawn and replaced newer version.

8-63

8-387

ISO 5832-11 Second edition 2014-09-15 Implants for surgery—Metallic materials—Part 11: Wrought titanium 6-aluminium 7-niobium alloy

Withdrawn and replaced with newer version.

8-177

ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Updated to incorporate transferred recognitions 3-76 and 17-9.

J. Neurology

17-9

ASTM F2129-08 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Transferred. See 8-177.

17-4

ASTM F647-94(2014) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application

Reaffirmation.

K. Obstetrics-Gynecology-Urology-Gastroenterology (OB-GYN-GU)/Gastroenterology

9-73

9-104

ANSI/AAMI/ISO 13958:2014 Concentrates for hemodialysis and related therapies

Withdrawn and replaced with newer version.

9-97

ISO 13958 Third edition 2014-04-01 Concentrates for haemodialysis and related therapies

Extent of recognition.

9-69

9-105

ANSI/AAMI 13959:2014 Water for hemodialysis and related therapies

Withdrawn and replaced with newer version.

9-100

ISO 11663 Second edition 2014-04-01 Quality of dialysis fluid for haemodialysis and related therapies

Extent of recognition.

9-71

9-106

ANSI/AAMI/ISO 11663:2014 Quality of dialysis fluid for hemodialysis and related therapies

Withdrawn and replaced with newer version.

9-70

9-107

ANSI/AAMI 23500:2014 Guidance for the preparation and quality management of fluids for hemodialysis and related therapies

Withdrawn and replaced with newer version.

9-102

ISO 4074 Second edition 2014-08-15 Natural latex rubber condoms—Requirements and test methods

Extent of recognition.

9-90

9-108

ISO 8009 Second edition 2014-11-15 Mechanical contraceptives—Reusable natural and silicone rubber contraceptive diaphragms—Requirements and tests

Withdrawn and replaced with newer version.

9-56

9-109

ASTM D3492-08 Standard Specification for Rubber Contraceptives (Male Condoms)

Withdrawn and replaced with newer version.

L. Ophthalmic

10-29

10-94

ISO 14730 Second edition 2014-10-01 Ophthalmic Optics—Contact lens care products—antimicrobial preservative efficacy testing and guidance on determining discard date

Withdrawn and replaced with newer version.

10-55

10-95

ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants—intraocular lenses—Part 6: Shelf-life and transport stability

Withdrawn and replaced with newer version.

10-62

10-96

ANSI Z80.10-2014 American National Standard for Opthalmics Ophthalmic Instruments—Tonometers

Withdrawn and replaced with newer version.

10-68

10-97

ISO 13212 Third edition 2014-09-01 Ophthalmic Optics-Contact lens care products—Guidelines for determination of shelf-life

Withdrawn and replaced with newer version.

10-82

10-98

ISO 11979-2 Second edition 2014-08-15 Ophthalmic implants—Intraocular lenses—Part 2: Optical properties and test methods

Withdrawn and replaced with newer version.

M. Orthopedic

11-240

11-287

ASTM F382-14 Standard Specification and Test Method for Metallic Bone Plates

Withdrawn and replaced newer version.

11-235

11-288

ASTM F2077-14 Test Methods for Intervertebral Body Fusion Devices

Withdrawn and replaced with newer version.

11-207

11-289

ASTM F2193-14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Withdrawn and replaced with newer version.

11-183

ASTM F1875-98 (Reapproved 2014) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

Reaffirmation.

11-266

ASTM F2665-09 (Reapproved 2014) Standard Specification for Total Ankle Replacement Prosthesis

Reaffirmation.

11-224

ASTM F2706-08 (Reapproved 2014) Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model.

Reaffirmation.

11-80

11-290

ISO 8828 Second edition 2014-11-15 Implants for surgery—Guidance on Care and Handling of Orthopaedic Implants

Withdrawn and replaced with newer version.

11-248

11-291

ISO 14242-1 Third edition 2014-10-15 Implants for surgery—Wear of total hip-joint prostheses—Part 1: Loading and displacement parameters for wear testing machines and corresponding environmental conditions for test

Withdrawn and replaced with newer version.

11-250

11-292

ISO 14243-3 Second edition 2014-11-01 Implants for surgery—Wear of total knee prostheses—Part 3: Loading and displacement parameters for wear—testing machines with displacement control and corresponding environmental conditions for test

Withdrawn and replaced with newer version.

N. Radiology

12-102

ANSI/IESNA RP-27.2-2000 (Reaffirmed 2011) Photobiological Safety for Lamp & Lamp Systems-Measurement Techniques

Reaffirmation.

12-212

12-289

IEC 62220-1-1 Edition 1.0 2015-03 Medical electrical equipment—Characteristics of digital x-ray imaging devices—Part 1-1: Determination of the detective quantum efficiency—Detectors used in radiographic imaging

Withdrawn and replaced with newer version.

12-229

12-290

IEC 61910-1 Edition 1.0 2014-09 Medical electrical equipment—Radiation dose documentation—Part 1: Radiation dose structured reports for radiography and radioscopy

Withdrawn and replaced with newer version.

12-278

12-291

IEC 62127-2 Edition 1.1 2013-02 Ultrasonics Hydrophones—Part 2: Calibration for ultrasonic fields up to 40 MHz

Withdrawn and replaced with newer version.

O. Sterility

14-193

14-457

ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging [Including: Amendment 1 (2014)]

Withdrawn and replaced with newer version including Amendment.

14-194

14-458

ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes[Including: Amendment 1 (2014)]

Withdrawn and replaced with newer version including Amendment.

14-195

14-459

ANSI/AAMI/ISO 11140-1:2014 Sterilization of health care products—Chemical indicators—Part 1: General requirements

Withdrawn and replaced with newer version.

14-287

ANSI/AAMI/ISO 11737-2:2009/(R)2014 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

Reaffirmation.

14-297

14-461

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 [Including: Amendment 1 (2013)]

Withdrawn and replaced with newer version including Amendment.

14-300

14-462

ASTM D4169—14 Standard Practice for Performance Testing of Shipping Containers and Systems

Withdrawn and replaced with newer version.

14-327

ISO 11737-2 Second edition 2009-11-15 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.

14-350

ANSI/AAMI/ISO 13408-4:2005/(R)2014, Aseptic processing of health care products—Part 4: Clean-in-place technologies

Reaffirmation.

14-353

14-460

ISO 11140-1 Third edition 2014-11-01 Sterilization of health care products—Chemical indicators—Part 1: General requirements

Withdrawn and replaced with newer version.

14-391

14-463

ISO/ASTM 51608 Third edition 2015-03-15 Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV

Withdrawn and replaced with newer version.

14-392

14-464

ISO/ASTM 51649 Third edition 2015-03-15 Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV

Withdrawn and replaced with newer version.

14-431

14-465

ISO/ASTM 51707 Third edition 2015-03-15 Guide for estimation of measurement uncertainty in dosimetry for radiation processing

Withdrawn and replaced with newer version.

14-440

14-466

USP 38-NF33:2015 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

Withdrawn and replaced with newer version.

14-441

14-467

USP 38-NF33:2015 <71> Sterility Tests

Withdrawn and replaced with newer version.

14-442

14-468

USP 38-NF33:2015 <85> Bacterial Endotoxins Test

Withdrawn and replaced with newer version.

14-443

14-477

USP 38-NF33:2015 <151> Pyrogen Test (USP Rabbit Test)

Withdrawn and replaced with newer version.

14-444

14-469

USP 38-NF33:2015 <161> Transfusion and Infusion Assemblies and Similar Medical Devices

Withdrawn and replaced with newer version.

14-445

14-470

USP 38-NF33:2015 Biological Indicator for Steam Sterilization—Self Contained

Withdrawn and replaced with newer version.

14-446

14-471

USP 38-NF33:2015 Biological Indicator for Dry-Heat Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-447

14-472

USP 38-NF33:2015 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-448

14-473

USP 38-NF33:2015 Biological Indicator for Steam Sterilization, Paper Carrier

Withdrawn and replaced with newer version.

14-449

14-474

USP 38-NF33:2015 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms

Withdrawn and replaced with newer version.

14-450

14-475

USP 38-NF33:2015 <55> Biological Indicators—Resistance Performance Tests

Withdrawn and replaced with newer version.

14-451

14-476

USP 38-NF33:2015 <1035> Biological Indicators for Sterilization

Withdrawn and replaced with newer version.

1

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

III. Listing of New Entries

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 040.

Table 2—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and date

A. Anesthesia

1-104

Medical electrical equipment—Part 2-13: Particular Requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015)]

ISO 80601-2-13 First Edition 2011-08-01 and Amendment 1 2015.

1-105

Medical electrical equipment—Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients

ISO 80601-2-72 First Edition 2015-04-11.

B. Biocompatibility

2-221

Biological Evaluation of Medical Devices: Part 2—Animal Welfare Requirements

ANSI/AAMI/ISO 10993-2:2006 (R2014).

2-222

Biological Evaluation of Medical Devices: Part 2—Animal Welfare Requirements

ISO 10993-2 Second edition 2006-07-15.

C. Cardiovascular

3-135

Cardiovascular implants and extracorporeal systems—Vascular device-drug combination products

ISO/TS 12417-1 First edition 2011-06-01.

3-136

Cardiovascular implants and extracorporeal systems—Vascular device-drug combination products

ANSI/AAMI/ISO TIR12417:2011.

3-137

Standard Guide for Testing Absorbable Stents

ASTM F3036-13.

3-138

Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents

ASTM F2942-13.

3-139

Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices

ISO 14117 First edition 2012-07-15.

D. General I (Quality Systems/Risk Management)

5-95

Medical devices—Part 1: Application of usability engineering to medical devices

IEC 62366-1 Edition 1.0 2015-02.

5-96

Medical devices—Part 1: Application of usability engineering to medical devices

ANSI/AAMI/IEC 62366-1:2015.

5-97

Small-bore connectors for liquids and gases in healthcare applications—Part 20: Common test methods

ISO 80369-20 First edition 2015-05-15.

E. General II (ES/EMC)

19-14

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

IEC 60601-1-11 Edition 2.0 2015-01.

19-15

Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

IEC 60601-1-12 Edition 1.0 2014-06.

F. GH/GPS

6-352

Standard Specification for Implantable Breast Prostheses

ASTM F703-07.

6-353

Standard Specification for Implantable Saline Filled Breast Prosthesis

ASTM F2051−00 (Reapproved 2014).

6-354

Standard Specification for Radiation Attenuating Protective Gloves

ASTM D7866-14.

G. IVD

7-257

Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline

CLSI M56-A.

7-258

Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standards- Twelfth Edition

CLSI M02-A12.

H. Materials

8-388

Implants for surgery—Ceramic materials—Part 2: Composite materials based on a high-purity alumina matrix with zirconia reinforcement

ISO 6474-2 First edition 2012-04-15.

8-389

Implants for surgery—Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices

ISO 15309 First edition 2013-12-01.

8-390

Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

ASTM F1925-09.

8-391

Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal To 70% Glycolide

ASTM F2313-10.

I. Nanotechnology

18-4

Technical Specification—Nanotechnologies—Vocabulary—Part 6: Nano-object characterization

ISO/TS 80004-6 First edition 2013-11-01.

J. Neurology

17-14

Transcutaneous electrical nerve stimulators

ANSI/AAMI NS4:2013.

K. OB-GYN-GU/Gastroenterology

9-103

Water treatment equipment for hemodialysis and related therapies

ANSI/AAMI 26722:2014.

L. Ophthalmic

10-99

Anionic and non-ionic surface active agents—Determination of critical micellization concentration—Method by measuring surface tension with a plate, stirrup, or ring,

ISO 4311 First edition 1979-06-01.

M. Orthopedic

11-293

Standard Test Method for Impingement of Acetabular Prostheses

ASTM F2582-14.

11-294

Standard Specification for Articulating Total Wrist Implants

ASTM F1357-14.

11-295

Standard Practice for Evaluation of Modular Connection of Proximally Fixed Femoral Hip Prosthesis

ASTM F2580-13.

N. Physical Medicine

16-194

Wheelchairs Part 25:Batteries and chargers for powered wheelchairs

ISO 7176-25 First edition 2013-07-15.

O. Radiology

12-292

IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling

IEEE Std 3333.2.1-2015.

P. Software/Informatics

13-73

Systematized Nomenclature of Medicine—Clinical Terms

IHTSDO SNOME-CT RF2 Release 2015.

13-74

Health informatics—Personal health device communication, Part 10424: Device Specialization—Sleep Apnoea Breathing Therapy Equipment (SABTE)

IEEE Std 11073-10424-2014.

13-75

Health informatics—Point-of-care medical device communication—Part 10102: Nomenclature—Annotated ECG

ISO/IEEE 11073-10102 First edition 2014-03-01.

13-76

Health informatics—Standard communication protocol—Part 91064: Computer-assisted electrocardiography

ISO 11073-91064 First edition 2009-05-01.

13-77

Information technology—Security techniques—Vulnerability disclosure

ISO/IEC 29147 First edition 2014-02-15.

13-78

Information technology—Security techniques—Vulnerability handling processes

ISO/IEC 30111 First edition 2013-11-01.

Q. Sterility

14-478

Flexible and semi-rigid endoscope processing in health care facilities

ANSI/AAMI ST91:2015.

1

All 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 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 revisions to the list of recognized consensus standards, as needed, in the

Federal Register

once a year, or more often if necessary. Beginning with Recognition List 033, FDA no longer announces minor revisions to the list of recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to

standards@cdrh.fda.gov.

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. The Center for Devices and Radiological Health (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,

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

includes a link to standards-related documents including the guidance and the current list of recognized standards. After publication in the

Federal Register

, this notice announcing “Modification to the List of

Recognized Standards, Recognition List Number: 040” will be available at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.

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.

VII. Submission of Comments and Effective Date

Interested persons may submit either electronic comments regarding this document to

http://www.regulations.gov

or written comments to the Division of Dockets Management (see

ADDRESSES

). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at

http://www.regulations.gov.

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: 040. These modifications to the list of recognized standards are effective upon publication of this notice in the

Federal Register

.

Dated: August 10, 2015.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2015-19991 Filed 8-13-15; 8:45 am]

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