Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 041

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: 041

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) 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: 041” (Recognition List Number: 041), 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. These modifications to the list of recognized standards are effective April 4, 2016

.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

•

Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to

http://www.regulations.gov

will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your

comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on

http://www.regulations.gov.

• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

•

Mail/Hand delivery/Courier (for written/paper submissions):

Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions:

All submissions received must include the Docket No. FDA-2004-N-0451 for “Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 041.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at

http://www.regulations.gov

or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. 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: 041.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on

http://www.regulations.gov.

Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at:

http://www.fda.gov/regulatoryinformation/dockets/default.htm.

Docket:

For access to the docket to read background documents or the electronic and written/paper comments received, go to

http://www.regulations.gov

and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

An electronic copy of Recognition List Number: 041 is available on the Internet 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: 041 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: 041” 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.

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 (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 standards 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 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: 041

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: 041” 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

1-92

1-106

ISO 17510 First Edition 2015-08-01 Medical Devices—Sleep Apnoea Breathing Therapy—Masks and Application Accessories

Withdrawn and replaced with newer version.

1-93

ISO 5361 Second Edition 2012-10-01 Anaesthetic and Respiratory Equipment—Tracheal Tubes and Connectors

Extent of recognition.

B. Biocompatibility

2-180

ANSI/AAMI/ISO 10993-16:2010/(R) 2014 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

Reaffirmation.

C. Cardiovascular

3-119

ISO 5841-3 Third Edition 2013-04-15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors [is-i] for implantable pacemakers

Withdrawn—Duplicate recognition—See 3-125.

3-138

ASTM F2942-13 Standard Guide For the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents

Extent of recognition.

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

4-121

4-221

ISO 7494-2 Second Edition 2015-04-01 Dentistry—Dental units—Part 2: Air, water, suction and wastewater system

Withdrawn and replaced with newer version.

4-132

4-222

ISO 6874 Third Edition 2015-09-01 Dentistry—Polymer-based pit and fissure sealants

Withdrawn and replaced with newer version.

4-178

4-223

ISO 6872 Fourth Edition 2015-06-01 Dentistry—Ceramic materials

Withdrawn and replaced with newer version.

4-190

ANSI/ASA S3.35-2010 (R2015) Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions

Reaffirmation.

4-194

ANSI/ADA Specification No. 78: 2006, Dental Obturating Cones (Modified adoption of ISO 6877-1:1995, Dental Obturating Points)

Extent of recognition.

4-202

ANSI/ADA Specification No. 58 Root Canal Files, Type H (Hedstrom)

Extent of recognition.

4-209

4-224

ISO 24234 Second Edition 2015-05-01 Dentistry—Dental amalgam

Withdrawn and replaced with newer version.

4-210

4-225

ISO 4823 Fourth Edition 2015-08-01 Dentistry—Elastomeric impression materials

Withdrawn and replaced with newer version.

4-213

ISO 7494-1 Second Edition 2011-08-15 Dentistry—Dental units—Part 1: General requirements and test methods

Extent of recognition.

4-214

ISO 10139-1 Second Edition 2005-02-15 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use [Including: Technical Corrigendum 1 (2006)]

Extent of recognition.

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

5-43

5-98

ANSI/ESD S20.20-2014 Protection of Electrical and Electronic Parts, Assemblies, and Equipment (Excluding Electrically Initiated Explosive Devices)

Withdrawn and replaced with newer version.

5-80

5-99

ASTM D4332-14 Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

Withdrawn and replaced with newer version.

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

19-7

19-16

ANSI/AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD) 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

Withdrawn and replaced with newer version.

19-7

AAMI/ANSI HA60601-1-11:2011, Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2010 MOD)

Transition period.

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

6-169

6-355

ASTM D3772—15 Standard Specification for Industrial Rubber Finger Cots

Withdrawn and replaced with newer version.

6-243

6-356

ASTM D5712—15 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-167

7-259

CLSI GP23-A Nongynecologic Cytologic Specimens: Collection And Cytopreparatory Techniques; Approved Guideline

Withdrawn and replaced with newer version.

7-132

7-260

CLSI MM03-A2 Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline

Withdrawn and replaced with newer version.

7-229

CLSI M02-A11 Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—Eleventh Edition

Withdrawn. See 7-258.

I. Materials

8-103

ASTM F1807-97 (Reapproved 2014) Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials

Reaffirmation.

8-107

ASTM F746-04 (Reapproved 2014) Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials

Reaffirmation.

8-114

ASTM F2255-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading

Reaffirmation.

8-115

ASTM F2256-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading

Reaffirmation.

8-116

ASTM F2258-05 (Reapproved 2015) Standard Test Method for Strength Properties of Tissue Adhesives in Tension

Reaffirmation.

8-121

ASTM F2005-05 (Reapproved 2015) Standard Terminology for Nickel-Titanium Shape Memory Alloys

Reaffirmation.

8-134

8-392

ASTM F2082-15 Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery

Withdrawn and replaced with newer version.

8-135

ASTM F2392-04 (Reapproved 2015) Standard Test Method for Burst Strength of Surgical Sealants

Reaffirmation.

8-136

ASTM F2458-05 (Reapproved 2015) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants

Reaffirmation.

8-167

8-393

ASTM F1350-15 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)

Withdrawn and replaced with newer version.

8-168

8-394

ASTM F1472-14 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400)

Withdrawn and replaced with newer version.

8-170

8-395

ASTM F961-14 Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)

Withdrawn and replaced with newer version.

8-177

8-396

ASTM F2129-15 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Withdrawn and replaced with newer version.

8-179

ASTM F754-08 (Reapproved 2015) Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Sheet, Tube, and Rod Shapes Fabricated from Granular Molding Powders

Reaffirmation.

8-184

8-397

ASTM F2516-14 Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials

Withdrawn and replaced with newer version.

8-189

8-398

ASTM F1108-14 Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)

Withdrawn and replaced with newer version.

8-190

8-399

ASTM F90-14 Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)

Withdrawn and replaced with newer version.

8-192

8-400

ASTM F1854-15 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants

Withdrawn and replaced with newer version.

8-200

ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

Reaffirmation.

8-204

8-401

ASTM F2118-14 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials

Withdrawn and replaced with newer version.

8-206

8-402

ASTM F688-14 Standard Specification for Wrought Cobalt-35Nickel-20Chromium 10Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)

Withdrawn and replaced with newer version.

8-225

ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

Withdrawn. See 8-200.

8-363

8-403

ASTM D638-14 Standard Test Method for Tensile Properties of Plastics

Withdrawn and replaced with newer version.

8-367

8-404

ASTM E647-15 Standard Test Method for Measurement of Fatigue Crack Growth Rates

Withdrawn and replaced with newer version.

8-369

ASTM F2003-02 (Reapproved 2015) Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air

Withdrawn. See 8-200.

8-386

8-405

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

Withdrawn and replaced with newer version.

8-387

8-406

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.

J. Nanotechnology

18-1

ASTM E2490-09 (Reapproved 2015) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)

Reaffirmation.

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

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

Withdrawn. Merged with 4-187.

9-83

9-110

ISO 8600-1 Fourth Edition 2015-10-15 Endoscopes—Medical endoscopes and endotherapy devices—Part 1: General requirements

Withdrawn and replaced with newer version.

9-96

CEN EN 1618:1997 Catheters Other Than Intravascular Catheters—Test Methods for Common Properties

Duplicate recognition number. See 9-113.

9-102

9-111

ISO 4074 Third Edition 2015-10-15 Natural rubber latex male condoms—Requirements and test methods

Withdrawn and replaced with newer version.

9-109

9-112

ASTM D3492-15 Standard Specification for Rubber Contraceptives (Male Condoms)

Withdrawn and replaced with newer version.

L. Ophthalmic

10-73

ANSI Z80.21-2010 (R2015) Ophthalmics—Instruments—General-Purpose Clinical Visual Acuity Charts

Reaffirmation.

M. Orthopedic

11-207

11-296

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.

11-214

11-297

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

Withdrawn and replaced with newer version.

11-216

11-298

ASTM F1264—14 Standard Specification and Test Methods for Intramedullary Fixation Devices

Withdrawn and replaced with newer version.

11-220

11-299

ASTM F2068—15 Standard Specification for Femoral Prostheses—Metallic Implants

Withdrawn and replaced with newer version.

11-227

ASTM F366-10 (Reapproved 2015) Standard Specification for Fixation Pins and Wires

Reaffirmation.

11-228

ASTM F564-10 (Reapproved 2015) Standard Specification and Test Methods for Metallic Bone Staples

Reaffirmation.

11-247

ASTM F2789-10 (Reapproved 2015) Standard Guide for Mechanical and Functional Characterization of Nucleus Devices

Reaffirmation.

11-256

ISO 14243-3 First Edition 2004-09-25 Implants for surgery—Wear of total knee-joint prostheses—Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including: Technical Corrigendum 1(2006)]

Withdrawn. See 11-292.

11-262

11-301

ASTM F2091-15 Standard Specification for Acetabular Prostheses

Withdrawn and replaced with newer version.

11-278

11-302

ASTM F1717-15 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with newer version.

N. Physical Medicine

16-158

16-195

ISO 7176-1 Third Edition 2014-10-01 Wheelchairs—Part 1: Determination of static stability

Withdrawn and replaced with newer version.

O. Radiology

12-139

NEMA UD 2-2004 (R2009) Acoustic output measurement standard for diagnostic ultrasound equipment, Revision 3

Reaffirmation.

12-187

NEMA MS 3-2008 (R2014) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images

Reaffirmation.

12-188

NEMA MS 1-2008 (R2014) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging

Reaffirmation.

12-195

NEMA MS 6-2008 (R2014) Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel, Non-Volume Coils in Diagnostic Magnetic Resonance Imaging (MRI)

Reaffirmation.

12-196

NEMA MS 2-2008 (R2014) Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images

Reaffirmation.

12-207

IEC 60601-2-33 Ed. 3.0 2010 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Extent of recognition.

12-209

12-293

IEC 60601-2-37 Ed. 2.1 b:2015 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Withdrawn and replaced with newer version.

12-236

12-294

IEC 60601-2-45 Ed. 3.1 b:2015 Medical electrical equipment—Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

Withdrawn and replaced with newer version.

12-257

12-297

ISO 2919 Third Edition 2012-02-15 Radiation protection—Sealed radioactive sources—General requirements and classification

Duplicate recognition number. See 12-297.

12-271

12-295

IEC 60601-2-33 Ed. 3.2 b:2015 Medical electrical equipment—Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis

Withdrawn and replaced with newer version.

12-274

12-296

IEC 60601-2-54 Ed. 1.1 b:2015 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy

Withdrawn and replaced with newer version.

12-288

NEMA MS 9-2008 (R2014) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images (MRI)

Reaffirmation.

P. Software/Informatics

13-8

13-79

IEC 62304 Edition 1.1 2015-06 Medical device software—Software life cycle processes

Withdrawn and replaced with newer version.

13-50

13-80

IEEE Std. 11073-20601: 2014 Health informatics—Personal health device communication—Part 20601: Application profile—Optimized Exchange Protocol [including: Corrigendum 1 (2015)]

Withdrawn and replaced with newer version.

13-51

IEEE Std. 11073-20601a-2010 Health informatics—Personal health device communication—Part 20601: Application profile—Optimized Exchange Protocol Amendment 1

Withdrawn. See 13-80.

Q. Sterility

14-227

ANSI/AAMI/ISO 11737-1:2006 (R)2011 Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on product

Extent of recognition.

14-261

ANSI/AAMI/ISO 17665-1:2006/(R)2013 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.

14-277

ISO/TS 17665-2 First Edition 2009-01-15 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665-1

Extent of recognition.

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

Extent of recognition.

14-291

ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of healthcare 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.

14-296

ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirements

Extent of recognition.

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.

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.

14-330

ISO 11137-3 First Edition 2006-04-15 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects

Extent of recognition.

14-333

ISO 17665-1 First Edition 2006-08-15 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.

14-337

ISO 14937 Second Edition 2009-10-15 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.

14-338

ISO 11138-1 Second Edition 2006-07-01 Sterilization of health care products—Biological indicators—Part 1: General requirements

Extent of recognition.

14-339

ANSI/AAMI/ISO 20857:2010 Sterilization of health care products—Dry heat—Requirements for the development, validation, and routine control of a sterilization process for medical devices

Extent of recognition.

14-340

ISO 20857 First Edition 2010-08-15 Sterilization of health care products—Dry heat—Requirements for the development, validation, and routine control of a sterilization process for medical devices

Extent of recognition.

14-349

ANSI/AAMI/ISO 13408-3:2006/(R)2015 Aseptic processing of health care products—Part 3: Lyophilization

Reaffirmation.

14-351

ANSI/AAMI/ISO 13408-5:2006/(R)2015 Aseptic processing of health care products—Part 5: Sterilization in place

Reaffirmation.

14-376

ANSI/AAMI/ISO TIR17665-2:2009 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1

Extent of recognition.

14-407

ISO 11737-1 Second Edition 2006-04-01 Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products [Including: Technical Corrigendum 1 (2007)]

Extent of recognition.

14-409

ISO 11137-2 Third Edition 2013-06-01 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

Extent of recognition.

14-428

ISO 11137-1 First Edition 2006-04-15 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)]

Extent of recognition.

14-438

ANSI/AAMI/ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose

Extent of recognition.

14-452

ISO 11135 Second Edition 2014, Sterilization of health care products—Ethylene oxide—Requirements for development, validation, and routine control of a sterilization process for medical devices

Extent of recognition.

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)]

Extent of recognition.

R. Tissue Engineering

15-8

15-42

ASTM F2064-14 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications

Withdrawn and replaced with newer version.

15-22

15-43

ASTM F2791-15 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions

Withdrawn and replaced with newer version.

15-24

ASTM F2721-09 (Reapproved 2014) Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects

Reaffirmation.

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: 041.

Table 2—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and date

A. Anesthesia

1-107

Anaesthetic and Respiratory Equipment—Conical Connectors—Part 1: Cones and Sockets

ANSI/AAMI/ISO 5356-1:2004.

1-108

Anaesthetic and Respiratory Equipment—Tracheal Tubes and Connectors

ANSI/AAMI/ISO 5361:2012.

1-109

Anaesthetic Reservoir Bags

ANSI/AAMI/ISO 5362:2006.

1-110

Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 1: Tubes and Connectors for Use in Adults

ANSI/AAMI/ISO 5366-1:2000.

1-111

Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Paediatric Tracheostomy Tubes

ANSI/AAMI/ISO 5366-3:2001.

1-112

Lung Ventilators—Part 4: Particular Requirements for Operator-Powered Resuscitators

ANSI/AAMI/ISO 10651-4:2002.

1-113

Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators

ANSI/AAMI/ISO 10651-5:2006.

1-114

Inhalational Anaesthesia Systems—Draw-over Anaesthetic Systems

ISO 18835 First Edition 2015-04-01.

1-115

Medical Electrical Equipment—Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment

ISO 80601-2-70 First Edition 2015-01-15.

B. Biocompatibility

2-223

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

ASTM F2901-13.

2-225

Standard Practice for Testing for Classical Complement Activation in Serum By Solid Materials

ASTM F2567-06 (Reapproved 2010).

C. Cardiovascular

3-140

Cardiovascular implants—Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques

ANSI/AAMI/ISO 5840-3: 2013.

3-141

Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors (IS-1) for implantable pacemakers

ANSI/AAMI/ISO 5841-3: 2013.

D. Dental/ENT

4-226

Dentistry—Powered polymerization activators

ISO 10650 First Edition 2015-09-01.

E. General I (Quality Systems/Risk Management)

5-100

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

ANSI/AAMI/ISO 80369-20:2015.

5-101

Small-bore connectors for liquids and gases in healthcare applications—Part 6: Connectors for neuraxial applications

AAMI/CN6:2015.

F. General II (ES/EMC)

19-17

American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters

ANSI/IEEE C63.18-2014.

19-18

Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1: General requirements [Including: Corrigendum 1 (2011)]

IEC 61010-1 Edition 3.0 2010-06.

G. GH/GPS

6-357

Intravascular Catheters—Sterile and Single-use Catheters—Part 6: Subcutaneous Implanted Ports

ISO 10555-6 First Edition 2015-04-15.

6-358

Infusion Equipment for Medical Use—Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus

ISO 8536-8 Second Edition 2015-06-15.

6-359

Infusion Equipment for Medical Use—Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment

ISO 8536-9 Second Edition 2015-06-15.

6-360

Infusion Equipment for Medical Use—Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment

ISO 8536-10 Second Edition 2015-06-15.

6-361

Infusion Equipment for Medical Use—Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment

ISO 8536-11 Second Edition 2015-06-15.

H. Materials

8-407

Standard Specification for Additive Manufacturing File Format (AMF) Version 1.1

ISO/ASTM 52915 First Edition 2013-06-01.

8-408

Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes

ASTM F3122-14.

8-409

Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion

ASTM F2924-14.

8-410

Standard Guide for Assessment of Absorbable Polymeric Implants

ASTM F2902-12.

8-411

Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants

ASTM F2579-10.

8-412

Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion

ASTM F2537-06 (Reapproved 2011).

8-413

Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing, and Wire to be used for Medical Devices

ASTM F2819-10 (Reapproved 2015).

8-414

Standard Practice for Reporting and Assessment of Residues on Single Use Implants

ASTM F2847-10.

8-415

Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR).

ASTM F2778-09 (Reapproved 2015).

8-416

Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

ASTM F2977-13.

8-417

Test Method for Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants

ASTM F3044-14.

8-418

Standard Test Methods for Determining Radiopacity for Medical Use

ASTM F640-12.

8-419

Standard Specification for Metal Injection Molded Titanium-6 Aluminum-4 Vanadium Components for Surgical Implant Applications

ASTM F2885-11.

8-420

Standard Specification for Metal Injection Molded Cobalt-28 Chromium-6 Molybdenum Components for Surgical Implant Applications

ASTM F2886-10.

I. Ophthalmic

10-100

Ophthalmic optics—Contact lens care products—Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms

ISO 18259 First Edition 2014-10-01.

J. Orthopedic

11-303

Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations

ASTM F3047M-15.

11-304

Measuring Accuracy after Mechanical Disturbances

ASTM F3107-14.

K. Physical Medicine

16-196

Wheelchairs—Part 7: Measurement of seating and wheel dimensions

ISO 7176-7 First Edition 1998-05-15.

16-197

Wheelchairs—Part 8: Requirements and test methods for static, impact, and fatigue strengths

ISO 7176-8 Second Edition 2014-12-15.

16-198

Wheelchairs—Part 22: Set-up procedures

ISO 7176-22 Second Edition 2014-09-01.

L. Software/Informatics

13-81

Health informatics—Personal health device communication—Part 10419: Device Specialization—Insulin Pump

IEEE Std. 11073-10419: 2015.

M. Sterility

14-479

Sterilization of health care products—Ethylene oxide—Requirements for development, validation, and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO 11135:2014.

N. Tissue Engineering

15-44

Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM) Active Standard

ASTM F2529-13.

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: 041” 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.

Dated: March 29, 2016.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2016-07467 Filed 4-1-16; 8:45 am]

BILLING CODE 4164-01-P