Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 050

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: 050

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: 050” (Recognition List Number: 050), 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 October 22, 2018.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

•

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

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

https://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

https://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):

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

• For written/paper comments submitted to the Dockets Management Staff, 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: 050.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at

https://www.regulations.gov

or at the Dockets Management Staff 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: 050.

• 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

https://www.regulations.gov.

Submit both copies to the Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket:

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

https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

An electronic copy of Recognition List Number: 050 is available on the internet at

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

See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 050 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: 050” to Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144.

FOR FURTHER INFORMATION CONTACT:

Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287,

CDRHStandardsStaff@fda.hhs.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 the

Federal Register

notice of September 13, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate use of Voluntary Consensus Standards in Premarket Submission for Medical Devices.” The guidance describes how FDA has implemented its standard recognition program and is available at

https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf.

Modifications to the initial list of recognized standards, as published in the

Federal Register

, can be accessed at

https://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. Additional information on the Agency's standards program is available at

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm.

II. Modifications to the List of Recognized Standards, Recognition List Number: 050

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 050” to identify the 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

2

A. Anesthesiology

1-85

1-139

ISO 80601-2-61 Second edition 2017-12 (Corrected version 2018-02) Medical electrical equipment—Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Withdrawn and replaced with newer version.

1-96

1-140

ISO 80601-2-55 Second edition 2018-02 Medical electrical equipment—Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors

Withdrawn and replaced with newer version.

B. Biocompatibility

2-176

2-255

ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

Withdrawn and replaced with newer version.

2-204

2-256

ASTM F720-17 Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test

Withdrawn and replaced with newer version.

2-233

2-257

ASTM F2382-17e1 Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

Withdrawn and replaced with newer version.

C. Cardiovascular

3-110

AAMI TIR41:2011/(R)2017 Technical Information Report Active implantable medical devices—Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators

Reaffirmation.

3-123

3-152

IEC 80601-2-30 Edition 1.1 2013-07 Medical electrical equipment—Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers

Withdrawn and replaced with newer version.

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

4-214

4-242

ISO 10139-1 Third edition 2018-03 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use

Withdrawn and replaced with newer version.

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

5-42

ASTM D903-98 (Reapproved 2017) Standard Test Method for Peel or Stripping Strength of Adhesive Bonds

Reaffirmation.

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

19-8

IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral Standard: Electromagnetic disturbances—Requirements and tests

Extent of recognition.

19-19

IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment—Part 4-2: Guidance and interpretation—Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

Extent of recognition.

19-21

19-30

AIM Standard 7351731 Rev. 2.00 Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers—An AIM Standard

Withdrawn and replaced with newer version.

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

6-123

ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury‐in‐Glass, Maximum Self‐Registering Clinical Thermometers

Reaffirmation.

6-254

ASTM F2100-11 (Reapproved 2018) Standard Specification for Performance of Materials Used in Medical Face Masks

Reaffirmation.

6-301

6-408

ISO 10555-1 Second edition 2013-06-15 Intravascular catheters—Sterile and single-use catheters—Part 1: General requirements [Including AMENDMENT 1 (2017)]

Withdrawn and replaced with newer version including amendment.

6-352

6-409

ASTM F703-18 Standard Specification for Implantable Breast Prostheses

Withdrawn and replaced with newer version.

H. In Vitro Diagnostics (IVD)

7-127

7-275

CLSI EP07 3rd Edition Interference Testing in Clinical Chemistry

Withdrawn and replaced with newer version.

7-171

7-276

CLSI M38 3rd Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi

Withdrawn and replaced with newer version.

7-201

7-277

CLSI GP41 7th Edition Collection of Diagnostic Venous Blood Specimens

Withdrawn and replaced with newer version.

7-204

7-278

CLSI M27 4th Edition Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts

Withdrawn and replaced with newer version.

7-217

CLSI M60 1st Edition Performance Standards for Antifungal Susceptibility Testing of Yeasts

Title change.

7-240

CLSI M27-S4 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Fourth Informational Supplement

Withdrawn. See 7-217.

7-245

CLSI EP09-A3 Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Third Edition

Withdrawn.

7-254

7-279

CLSI M07 11th Edition Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically

Withdrawn and replaced with newer version.

7-258

7-280

CLSI M02 13th Edition Performance Standards for Antimicrobial Disk Susceptibility Tests

Withdrawn and replaced with newer version.

7-271

7-281

CLSI M100 28th Edition Performance Standards for Antimicrobial Susceptibility Testing

Withdrawn and replaced with newer version.

I. Materials

8-57

8-465

ISO 5832-2 Fourth edition 2018-03 Implants for surgery—Metallic materials—Part 2: Unalloyed titanium

Withdrawn and replaced with newer version.

8-112

ASTM F1044-05 (Reapproved 2017)e1 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings

Reaffirmation.

8-128

8-466

ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment

Withdrawn and replaced with newer version.

8-330

8-467

ASTM F1978-18 Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser

Withdrawn and replaced with newer version.

8-334

8-468

ASTM F2459-18 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis

Withdrawn and replaced with newer version.

8-372

8-469

ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)

Withdrawn and replaced with newer version.

8-380

ASTM F1160-14 (Reapproved 2017)e1 Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings

Reaffirmation.

8-382

8-470

ASTM F2102-17 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants

Withdrawn and replaced with newer version.

8-390

8-471

ASTM F1925-17 Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants

Withdrawn and replaced with newer version.

8-412

ASTM F2537-06 (Reapproved 2017) Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion

Reaffirmation.

8-414

8-472

ASTM F2847-17 Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments

Withdrawn and replaced with newer version.

8-419

8-473

ASTM F2885-17 Standard Specification for Metal Injection Molded Titanium-6Aluminum-4Vanadium Components for Surgical Implant Applications

Withdrawn and replaced with newer version. Extent of recognition.

8-420

8-474

ASTM F2886-17 Standard Specification for Metal Injection Molded Cobalt-28Chromium-6Molybdenum Components for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-436

8-475

ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications

Withdrawn and replaced with newer version.

8-448

8-476

ASTM F2004-17 Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis

Withdrawn and replaced with newer version.

8-454

8-477

ASTM F2129-17b Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices

Withdrawn and replaced with newer version.

J. Nanotechnology

No new entries at this time.

K. Neurology

No new entries at this time.

L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)

9-43

9-117

ISO 16038 Second edition 2017-11 Male condoms—Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms

Withdrawn and replaced with newer version.

9-67

ASTM D7661-10 (Reapproved 2017) Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

Reaffirmation.

9-92

9-118

ISO 8637-1 First edition 2017-11 Extracorporeal systems for blood purification—Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

Withdrawn and replaced with newer version.

9-95

9-119

IEC 60601-2-36 Edition 2.0 2014-04 Medical electrical equipment—Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy

Withdrawn and replaced with new recognition number.

9-112

9-120

ASTM D3492-16 Standard Specification for Rubber Contraceptives (Male Condoms)

Withdrawn and replaced with newer version.

M. Ophthalmic

10-56

ANSI Z80.12-2007 (R2017) American National Standard for Ophthalmics—Multifocal Intraocular Lenses

Reaffirmation.

10-57

ANSI Z80.13-2007 (R2017) American National Standard for Ophthalmics—Phakic Intraocular Lenses

Reaffirmation.

10-60

10-111

ISO 11981 Third edition 2017-11 Ophthalmic optics—Contact lenses and contact lens care products—Determination of physical compatibility of contact lens care products with contact lenses

Withdrawn and replaced with newer version.

10-67

10-112

ISO 11986 Third edition 2017-11 Ophthalmic optics—Contact lenses and contact lens care products—Determination of preservative uptake and release

Withdrawn and replaced with newer version.

10-84

ANSI Z80.11-2012 (R2017) American National Standard for Ophthalmics—Laser Systems for Corneal Reshaping

Reaffirmation.

N. Orthopedic

11-185

ASTM F2267-04 (Reapproved 2018) Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

Reaffirmation.

11-197

ASTM F983-86 (Reapproved 2018) Standard Practice for Permanent Marking of Orthopaedic Implant Components

Reaffirmation.

11-199

ASTM F565-04 (Reapproved 2018) Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Reaffirmation.

11-203

11-322

ASTM F1541-17 Standard Specification and Test Methods for External Skeletal Fixation Devices

Withdrawn and replaced with newer version.

11-224

11-323

ASTM F2706-17 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

Withdrawn and replaced with newer version.

11-226

8-478

ASTM F1089-18 Standard Test Method for Corrosion of Surgical Instruments

Withdrawn and replaced with newer version. Transferred.

11-227

11-324

ASTM F366-17 Standard Specification for Fixation Pins and Wires

Withdrawn and replaced with newer version.

11-228

11-325

ASTM F564-17 Standard Specification and Test Methods for Metallic Bone Staples

Withdrawn and replaced with newer version.

11-245

11-326

ASTM F384-17 Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices

Withdrawn and replaced with newer version.

11-257

11-327

ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws

Withdrawn and replaced with newer version.

11-261

11-328

ASTM F1378-17 Standard Specification for Shoulder Prostheses

Withdrawn and replaced with newer version.

11-271

11-329

ASTM F2180-17 Standard Specification for Metallic Implantable Strands and Cables

Withdrawn and replaced with newer version.

11-284

11-330

ASTM F2028-17 Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

Withdrawn and replaced with newer version.

11-288

11-331

ASTM F2077-17 Test Methods for Intervertebral Body Fusion Devices

Withdrawn and replaced with newer version.

11-296

11-332

ASTM F2193-18 Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Withdrawn and replaced with newer version.

11-297

11-333

ASTM F382-17 Standard Specification and Test Method for Metallic Bone Plates

Withdrawn and replaced with newer version.

11-310

ASTM F1611-00 (Reapproved 2018) Standard Specification for Intramedullary Reamers

Reaffirmation.

11-315

11-334

ASTM F1829-17 Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

Withdrawn and replaced with newer version.

11-318

11-335

ASTM F3141-17a Standard Guide for Total Knee Replacement Loading Profiles

Withdrawn and replaced with newer version.

O. Physical Medicine

16-159

16-202

ISO 7176-2 Third edition 2017-10 Wheelchairs—Part 2: Determination of dynamic stability of electric wheelchairs

Withdrawn and replaced with newer version.

16-185

ANSI RESNA WC-2:2009 American National Standard for Wheelchairs—Volume 2, Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters

Extent of recognition.

16-193

16-203

ASME A18.1-2017 Safety Standard for Platform Lifts and Stairway Chairlifts

Withdrawn and replaced with newer version.

P. Radiology

12-202

IEC 60601-2-43 Edition 2.0 2010-03 Medical electrical equipment—Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures

Recognition restored with transition period.

12-204

IEC 60601-2-28 Edition 2.0 2010-03 Medical electrical equipment—Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis

Recognition restored with transition period.

12-296

12-317

IEC 60601-2-54 CONSOLIDATED VERSION Edition 1.1 2015-04 Medical electrical equipment—Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy [Including: Amendment 2 (2018)]

Withdrawn and replaced with newer version including amendment.

Q. Software/Informatics

No new entries at this time.

R. Sterility

14-138

14-512

ISO 13408-2 Second edition 2018-01 Aseptic processing of health care products—Part 2: Sterilizing filtration

Withdrawn and replaced with newer version.

14-275

ANSI/AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness

Reaffirmation.

14-293

ANSI/AAMI ST50:2004/(R)2018 Dry heat (heated air) sterilizers

Reaffirmation.

14-294

ANSI/AAMI ST40:2004/(R)2018 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities

Reaffirmation.

14-295

ANSI/AAMI ST81:2004/(R)2016 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices

Withdrawn. See 14-515.

14-344

14-513

ASTM F2825-18 Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery

Withdrawn and replaced with newer version.

14-407

14-514

ISO 11737-1 Third edition 2018-01 Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products

Withdrawn and replaced with newer version.

S. Tissue Engineering

No new entries at this time.

1

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

2

Standards that are “Withdrawn” or “Withdrawn and replaced with newer version” will have a transition period with an expiration date as noted in the recognition database

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

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: 050.

Table 2—New Entries to the List of Recognized Standards

Recognition No.

Title of standard

1

Reference No. and date

A. Anesthesiology

No new entries at this time.

B. Biocompatibility

No new entries at this time.

C. Cardiovascular

3-153

Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems

ASTM F2743-11.

3-154

Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices

ASTM F3211-17.

3-155

Medical electrical equipment—Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems

IEC 60601-2-47 Edition 2.0 2012-02.

3-156

Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO 14708-1 Second edition 2014-08-15.

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

4-243

Corrosion Test Methods

ANSI/ADA Standard No. 97:2002/ISO 10271:2001 Reaffirmed by ANSI: May 29, 2013.

4-244

Dentistry—Test methods for rotary instruments

ISO 8325 Second edition 2004-09-15.

4-245

Dentistry—Corrosion test methods for metallic materials

ISO 10271 Second edition 2011-08-01.

4-246

Dentistry—Pre-capsulated dental amalgam

ISO 20749 First edition 2017-03.

4-247

Dentistry—Laser welding and filler materials

ISO 28319 Second edition 2018-04.

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

5-118

Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms

AAMI TIR66:2017.

5-119

Medical devices—Connectors for reservoir delivery systems for healthcare applications—Part 3: Enteral application

ISO 18250-3 First edition 2018-06.

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

19-31

American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment

ANSI C63.15-2017 (Revision of ANSI C63.15-2016).

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

No new entries at this time.

H. In Vitro Diagnostics (IVD)

7-282

Performance Standards for Antifungal Susceptibility Testing of Yeasts

CLSI M60 1st Edition.

7-283

Essential Tools for Implementation and Management of a Point-of-Care Testing Program

CLSI POCT04 3rd Edition.

7-284

Supplemental Tables for Interference Testing in Clinical Chemistry

CLSI EP37 1st Edition.

I. Materials

8-479

Implants for surgery—Homopolymers, copolymers and blends on poly(lactide)—In vitro degradation testing

ISO 13781 Second edition 2017-07.

J. Nanotechnology

No new entries at this time.

K. Neurology

No new entries at this time.

L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)

No new entries at this time.

M. Ophthalmic

10-113

American National Standard for Ophthalmics—Toric Intraocular Lenses

ANSI Z80.30-2018.

N. Orthopedic

11-336

Wear of implant materials—Polymer and metal wear articles—Isolation and characterization

ISO 17853 Third edition 2011-03-01.

11-337

Implants for surgery—Roentgen stereophotogrammetric analysis for the assessment of migration of orthopaedic implants

ISO 16087 First edition 2013-10-01.

11-338

Implants for surgery—Determination of impact resistance of ceramic femoral heads for hip joint prostheses

ISO 11491 First edition 2017-07.

11-339

Implants for surgery—Partial and total hip joint prostheses—Part 2: Articulating surfaces made of metallic, ceramic and plastics materials [Including AMENDMENT1 (2016)]

ISO 7206-2 Third edition 2011-04-01 AMENDMENT 1 2016-09-15.

11-340

Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices

ASTM F3018-17.

11-341

Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements

ASTM F3140-17.

O. Physical Medicine

No new entries at this time.

P. Radiology

12-318

Medical electrical equipment—Part 2-64: Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment

IEC 60601-2-64 Edition 1.0 2014-09.

12-319

Medical electrical equipment—Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

IEC 60601-2-68 Edition 1.0 2014-09.

12-320

Medical electrical equipment—Medical light ion beam equipment—Performance characteristics

IEC 62667 Edition 1.0 2017-08.

Q. Software/Informatics

No new entries at this time.

R. Sterility

14-515

Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices

ISO 17664 Second edition 2017-10.

14-516

Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration

ASTM F3039-15.

14-517

Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

ASTM F3293-18.

S. Tissue Engineering

15-55

Standard Guide for Micro-computed Tomography of Tissue Engineered Scaffolds

ASTM F3259-17.

1

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

IV. List of Recognized Standards

FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.

Such standards are those that FDA has recognized by notice published in the

Federal Register

or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet

appeared in the

Federal Register

). 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.

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

CDRHStandardsStaff@fda.hhs.gov.

To be considered, such recommendations should contain, at a minimum, the following information available at

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123739.htm.

Dated: October 16, 2018.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2018-22977 Filed 10-19-18; 8:45 am]

BILLING CODE 4164-01-P