Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 026

---
identifier: "/us/fr/2011-5815"
source: "fr"
legal_status: "authoritative_unofficial"
title: "Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 026"
title_number: 0
title_name: "Federal Register"
section_number: "2011-5815"
section_name: "Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 026"
positive_law: false
currency: "2011-03-14"
last_updated: "2011-03-14"
format_version: "1.1.0"
generator: "[email protected]"
agency: "Health and Human Services Department"
document_number: "2011-5815"
document_type: "notice"
publication_date: "2011-03-14"
agencies:
  - "Health and Human Services Department"
  - "Food and Drug Administration"
fr_citation: "76 FR 13631"
fr_volume: 76
docket_ids:
  - "Docket No. FDA-2004-N-0451"
fr_action: "Notice."
---


#  Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 026

**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: 026” (Recognition List Number: 026), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

**DATES:**

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

**ADDRESSES:**

Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 026” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 20993. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-847-8149. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person ( *see**FOR FURTHER INFORMATION CONTACT* ). Submit electronic comments by e-mail: *[email protected].* This document may also be accessed on FDA's Internet site at *http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See* section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 026 modifications and other standards related information.

**FOR FURTHER INFORMATION CONTACT:**

Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-6574.

**I. Background**

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the *Federal Register* of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards.

Modifications to the initial list of recognized standards, as published in the *Federal Register* , are identified in Table 1 as follows:

|  |
| --- |
| February 25, 1998 (63 FR 9561). |
| October 16, 1998 (63 FR 55617). |
| July 12, 1999 (64 FR 37546). |
| November 15, 2000 (65 FR 69022). |
| May 7, 2001 (66 FR 23032). |
| January 14, 2002 (67 FR 1774). |
| October 2, 2002 (67 FR 61893). |
| April 28, 2003 (68 FR 22391). |
| March 8, 2004 (69 FR 10712). |
| June 18, 2004 (69 FR 34176). |
| October 4, 2004 (69 FR 59240). |
| May 27, 2005 (70 FR 30756). |
| November 8, 2005 (70 FR 67713). |
| March 31, 2006 (71 FR 16313). |
| June 23, 2006 (71 FR 36121). |
| November 3, 2006 (71 FR 64718). |
| May 21, 2007 (72 FR 28500). |
| September 12, 2007 (72 FR 52142). |
| December 19, 2007 (72 FR 71924). |
| September 9, 2008 (73 FR 52358). |
| March, 18, 2009 (74 FR 11586). |
| September 8, 2009 (74 FR 46203). |
| May 5, 2010 (75 FR 24711). |
| June 10, 2010 (75 FR 32943). |
| October 4, 2010 (75 FR 61148). |

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: 026**

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA will use the term “Recognition List Number: 026” to identify these current modifications.

In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In section III of this document, FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA.

| Old | Replacement recognition | Title of standard | Change |
| --- | --- | --- | --- |
|  |  |  |  |
| 1-56 |  | CGA V-7.1 1997 (R2003) (2008) Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases—First Edition | Reaffirmation. |
|  |  |  |  |
| 2-96 | 2-162 | ASTM F1903-10 Standard Practice for Testing For Biological Responses to Particles In Vitro | Withdrawn and replaced with newer version. |
| 2-117 |  | ANSI/AAMI/ISO 10993-3:2003/(R)2009 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity | Extent of recognition. |
|  |  |  |  |
| 3-54 |  | ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular implants—Tubular vascular prostheses | Reaffirmation. |
| 3-58 |  | ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implants—Cardiac valve prostheses | Reaffirmation. |
| 3-66 |  | ASTM F 2081-06 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents | Device affected, Processes impacted, Type of standard, CFR citation and product codes, and Contact person. |
|  |  |  |  |
| 4-89 |  | ADA Specification No. 53 Polymer-Based Crowns and Bridge Resins | Reaffirmation. |
| 4-111 |  | ADA Specification No. 13 Denture Cold-Curing Repair Resins: 1981 (Reaffirmed 2006) | Withdrawn. |
| 4-112 |  | ADA Specification No. 16 Dental Impression Paste—Zinc Oxide Eugenol Type | Withdrawn. |
| 4-124 | 4-191 | ANSI/ASA S3.22-2009 American National Standard Specification of Hearing Aid Characteristics | Withdrawn and replaced with newer version. |
| 4-127 | 4-192 | ADA Specification 58 Root Canal Files, Type H (Hedstrom) 2007 | Withdrawn and replaced with newer version. |
| 4-138 | 4-193 | ADA Specification No. 15 Artificial Teeth for Dental Prostheses | Withdrawn and replaced with newer version. |
| 4-148 | 4-194 | ADA Specification No. 78 Dental Obturating Cones | Withdrawn and replaced with newer version. |
| 4-158 |  | ISO 10139-1:2005 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Technical Corrigendum 1:2006 | Withdrawn duplicate. 
                                
                                 4-189. |
|  |  |  |  |
| 6-144 | 6-243 | ASTM D5712-10 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method | Withdrawn and replaced with a newer version. |
| 6-145 |  | ASTM D3578-05 Standard Specification for Rubber Examination Gloves | Reaffirmation. |
| 6-149 |  | ASTM D7160-05 (Reapproved 2010) Standard Practice for Determination of Expiration Dating for Medical Gloves | Reaffirmation. |
| 6-150 |  | ASTM D7161-05 (Reapproved 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions | Reaffirmation. |
| 6-165 |  | ASTM D6977-04 (Reapproved 2010) Standard Specification for Polychloroprene Examination Gloves for Medical Application | Reaffirmation. |
| 6-167 | 6-244 | ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application | Withdrawn and replaced with newer version. |
| 6-169 |  | ASTM D3772-01 (Reapproved 2010) Standard Specification for Natural Rubber Finger Cots | Reaffirmation. |
| 6-201 | 6-245 | ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feed | Withdrawn and replaced with newer version. |
| 6-218 | 6-246 | USP 33-NF 28 2010 <11> Nonabsorbable Surgical Suture | Withdrawn and replaced with newer version. |
| 6-220 | 6-247 | USP 33-NF 28 2010 Absorbable Surgical Suture | Withdrawn and replaced with newer version. |
| 6-221 | 6-248 | USP 33-NF 28 2010 <881> Tensile Strength | Withdrawn and replaced with newer version. |
| 6-222 | 6-249 | USP 33-NF 28 2010 <861> Suture-Diameter | Withdrawn and replaced with newer version. |
| 6-223 | 6-250 | USP 33-NF 28 2010 <871> Sutures—Needle Attachment | Withdrawn and replaced with newer version. |
| 6-224 | 6-251 | USP 33 NF-28 2010 <11> Sterile Water for Irrigation | Withdrawn and replaced with newer version. |
| 6-225 | 6-252 | USP 33 NF-28 2010 <11> Heparin Lock Flush Solution | Withdrawn and replaced with newer version. |
|  |  |  |  |
| 7-183 |  | CLSI M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi | Withdrawn duplicate. 
                                
                                 7-171. |
| 7-188 | 7-218 | CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second Edition | Withdrawn and replaced with newer version. |
|  |  |  |  |
| 8-10 |  | ASTM F603-00 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application | Withdrawn. |
| 8-88 | 8-195 | ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings | Withdrawn and replaced with newer version. |
| 8-101 |  | ASTM F 2118—03 (Reapproved 2009) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials | Reaffirmation. |
| 8-103 |  | ASTM F1801—97 (Reapproved 2009)
                                
                                
                                 Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials | Reaffirmation. |
| 8-107 |  | ASTM F746—04 (Reapproved 2009) 
                                
                                
                                 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials | Reaffirmation. |
| 8-117 |  | ASTM F86—04 (Reapproved 2009) Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants | Reaffirmation. |
|  |  |  |  |
| 9-47 |  | AAMI RD16 Cardiovascular implants and artificial organs—Hemodialyzers, hemodiafilters | Withdrawn. 
                                
                                 9-65. |
| 9-48 |  | AAMI RD17 Cardiovascular implants and artificial organs—Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters | Withdrawn. 
                                
                                 9-66. |
| 9-50 |  | ANSI/AAMI RD52:2004/(R)2010 and ANSI/AAMI RD52:2004/A1:2007/(R)2010, A2:2007/(R)2010, A3:2009, & A4:2009 (Consolidated Text) Dialysate for haemodialysis | Reaffirmation. |
| 9-51 | 9-65 | ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators | Withdrawn and replaced with newer version. |
| 9-52 | 9-66 | ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters | Withdrawn and replaced with newer version. |
| 9-55 |  | ANSI/AAMI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009 Water treatment equipment for haemodialysis applications | Reaffirmation. |
|  |  |  |  |
| 11-168 |  | ASTM F 1781-03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants | Reaffirmation. |
| 11-183 |  | ASTM F1875-98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface | Reaffirmation. |
|  |  |  |  |
| 16-30 | 16-167 | ISO 7176-9: Third edition, 2009-11-15 Wheelchairs—Part 9: Climatic tests for electric wheelchairs | Withdrawn and replaced with newer version. |
| 16-31 | 16-168 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stability | Withdrawn and replaced with newer version. |
| 16-32 | 16-169 | RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs | Withdrawn and replaced with newer version. |
| 16-33 | 16-170 | RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes | Withdrawn and replaced with newer version. |
| 16-34 | 16-171 | RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range | Withdrawn and replaced with newer version. |
| 16-35 | 16-172 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space | Withdrawn and replaced with newer version. |
| 16-36 | 16-173 | RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs | Withdrawn and replaced with newer version. |
| 16-37 | 16-174 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions | Withdrawn and replaced with newer version. |
| 16-38 | 16-175 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths | Withdrawn and replaced with newer version. |
| 16-39 | 16-176 | RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs | Withdrawn and replaced with newer version. |
| 16-40 | 16-177 | RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs | Withdrawn and replaced with newer version. |
| 16-41 | 16-178 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies | Withdrawn and replaced with newer version. |
| 16-42 | 16-179 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces | Withdrawn and replaced with newer version. |
| 16-43 | 16-180 | RESNA WC-2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs—Requirements and test methods | Withdrawn and replaced with newer version. |
| 16-44 | 16-181 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling | Withdrawn and replaced with newer version. |
| 16-45 | 16-182 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts—Requirements and test methods | Withdrawn and replaced with newer version. |
| 16-46 | 16-183 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 20: Determination of the performance of stand-up type wheelchairs | Withdrawn and replaced with newer version. |
| 16-47 | 16-184 | RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up procedures | Withdrawn and replaced with newer version. |
| 16-48 |  | ANSI/RESNA WC/Volume 1-1998, Section 93: Maximum Overall Dimensions | Withdrawn. |
| 16-49 |  | ANSI/RESNA WC/Volume 1-1998, Section 0: Nomenclature, Terms, and Definitions | Withdrawn. |
| 16-160 | 16-185 | 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 | Withdrawn and replaced with newer version. |
| 16-161 | 16-186 | ASME A18.1-2008 (Revision of ASME A18.1-2005) Safety Standard for Platform Lifts and Stairway Chairlifts | Withdrawn and replaced with newer version. |
|  |  |  |  |
| 12-122 | 12-217 | IEC 62083 Edition 2.0:2009-09 Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems | Withdrawn and replaced with newer version. |
| 12-36 |  | IEC 60601-2-9 (1996-10) Medical electrical equipment—Part 2: Particular requirements for the safety of patient contact dosimeters used in radiotherapy with electrically connected radiation detectors—Ed. 2.0. | Withdrawn. |
| 12-183 | 12-218 | NEMA PS 3.1—3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) Set | Withdrawn and replaced with newer version. |
|  |  |  |  |
| 13-4 |  | UL 1998 Standard for Safety Software in Programmable Components, Second Edition | Reaffirmation. |
|  |  |  |  |
| 14-265 | 14-301 | USP 33:2010 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests | Withdrawn and replaced with newer version. |
| 14-266 | 14-302 | USP 33: 2010 <71> Sterility Tests | Withdrawn and replaced with newer version. |
| 14-267 | 14-303 | USP 33:2010 <85> Bacterial Endotoxins Test | Withdrawn and replaced with newer version. |
| 14-268 | 14-304 | USP 33:2010 <151> Pyrogen Test | Withdrawn and replaced with newer version. |
| 14-269 | 14-305 | USP 33:2010 <161> Transfusion and Infusion Assemblies and Similar Medical Devices | Withdrawn and replaced with newer version. |
| 14-270 | 14-306 | USP 33:2010 Biological Indicators for Steam Sterilization, Self-Contained | Withdrawn and replaced with newer version. |
| 14-271 | 14-307 | USP 33:2010 Biological Indicator for Dry-Heat Sterilization, Paper Carrier | Withdrawn and replaced with newer version. |
| 14-272 | 14-308 | USP 33:2010 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier | Withdrawn and replaced with newer version. |
| 14-273 | 14-309 | USP 33:2010 Biological Indicator for Steam Sterilization, Paper Carrier | Withdrawn and replaced with newer version. |
| 14-278 | 14-310 | USP 33:2010 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms | Withdrawn and replaced with newer version. |

**III. Listing of New Entries**

In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 026.

| Recognition No. | Title of standard | Reference No. and date |
| --- | --- | --- |
|  |  |  |
| 1-84 | Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Paediatric tracheostomy tubes TECHNICAL CORRIGENDUM 1 | ISO 5366-3:2001 TECHNICAL CORRIGENDUM 1. |
|  |  |  |
| 2-163 | Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products | ANSI/AAMI/ISO 10993-9:2009. |
| 2-164 | Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices | ANSI/AAMI/ISO 10993-13:2010. |
| 2-165 | Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics | ANSI/AAMI/ISO 10993-14:2001. |
| 2-166 | Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables | ANSI/AAMI/ISO 10993-16:2010. |
| 2-167 | Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials | ISO/TS 10993-19 First edition 2006-06-01. |
| 2-168 | Biological evaluation of medical devices— Part 9: Framework for identification and quantification of potential degradation products | ISO 10993-9 Second edition 2009-12-15. |
| 2-169 | Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices | ISO 10993-13 First edition 1998-11-15. |
| 2-170 | Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics | ISO 10993-14 First edition 2001-11-15. |
| 2-171 | Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables | ISO 10993-16 Second edition 2010-02-15. |
| 2-172 | Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materials | ANSI/AAMI/ISO TIR10993-19:2006. |
|  |  |  |
| 3-83 | Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices | ANSI/AAMI/ISO 14708-5:2010. |
| 3-84 | Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses Amendment 1: Test methods | ANSI/AAMI/ISO 25539-1:2003/A1:2005/(R)2009. |
| 3-85 | Cardiovascular implants—Endovascular devices—Part 2: Vascular stents | ANSI/AAMI/ISO 25539-2:2008. |
| 3-86 | Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System | ASTM F 2394-07. |
| 3-87 | Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents | ASTM F 2477-07. |
| 3-88 | Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading | ASTM F 2514-08. |
| 3-89 | Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirements | ISO 27186 First edition 2010-03-15. |
| 3-90 | Cardiovascular implants—Tubular vascular prostheses | ISO 7198 First edition 1998-08-01. |
| 3-91 | Cardiovascular implants—Cardiac valve prostheses | ISO 5840 Fourth edition 2005-03-01. |
| 3-92 | Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices | ISO 14708-5 First edition 2010-02-01. |
| 3-93 | Cardiovascular implants—Endovascular device—Part 1: Endovascular prostheses AMENDMENT 1: Test methods | ISO 25539-1 First edition 2001-11-13 AMENDMENT 1 2005-07-15. |
| 3-94 | Cardiovascular implants—Endovascular devices—Part 2: Vascular stents | ISO 25539-2 First edition 2008-09-01. |
|  |  |  |
| 5-63 | Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements | ISO 80369-1 First edition 2010-12-15. |
| 5-64 | Small bore connectors for liquids and gases in healthcare applications—Part 1: General requirements | AAMI/ISO/FDS-1 80369-01 2010. |
|  |  |  |
| 8-196 | Implants for surgery—Metallic materials—Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1 | ISO 5832-1:2007 TECHNICAL CORRIGENDUM 1 2008-04-15. |
| 8-197 | Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1 | ISO 5832-12:2007 TECHNICAL CORRIGENDUM 1 2008-09-15. |
| 8-198 | Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants | ASTM F 2102-06
                                
                                
                                . |
| 8-199 | Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants | ASTM F 2633-07. |
| 8-200 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air | ASTM F 2003-02 (Reapproved 2008). |
| 8-201 | Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) | ASTM F 2214-02 (Reapproved 2008). |
| 8-202 | Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical Implants | ASTM F 2183-02 (Reapproved 2008). |
|  |  |  |
| 18-1 | Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS) | ASTM E 2490-09. |
|  |  |  |
| 10-62 | Ophthalmics—Ophthalmic Instruments—Tonometers | ANSI Z80.10-2009. |
| 10-63 | Ophthalmic implants—Intraocular lenses—Guidance on assessment of the need for clinical investigation of intraocular lens design modifications | ISO/TR 22979-2006. |
|  |  |  |
| 12-219 | Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots CORRIGENDUM 1 | IEC 60336 (Fourth edition—2005). |
| 12-220 | Safety of laser products—Part 1: Equipment classification and requirements CORRIGENDUM 1 | IEC 60825-1 (Second edition—2007). |
| 12-221 | Evaluation and routine testing in medical imaging departments—Part 3-4: Acceptance tests—Imaging performance of dental X-ray equipment | IEC 61223-3-4 First edition 2000-03. |
| 12-222 | Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment | IEC 61223-3-5 First edition 2004-08. |
| 12-223 | Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1 | IEC 61223-3-5 (First edition 2004). |
| 12-224 | Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1 | IEC 60601-2-44 (Third edition—2009). |
| 12-225 | Computed Tomography Dose Check | NEMA XR 25 2010. |
| 12-226 | Evaluation and routine testing in medical imaging departments—Part 2-6: Constancy tests—Imaging performance of computed tomography X-ray equipment | IEC 61223-2-6 Second edition 2006-11. |
|  |  |  |
| 15-25 | ASTM F2312—10 Standard Terminology Relating to Tissue Engineered Medical Products | ASTM F2312-10. |
| 15-26 | ASTM F2211—04 Standard Classification for Tissue Engineered Medical Products (TEMPs) | ASTM F2211-04. |

**IV. List of Recognized Standards**

FDA maintains the Agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at *http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.* FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the *Federal Register* , this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the *Federal Register* once a year, or more often, if necessary.

**V. Recommendation of Standards for Recognition by FDA**

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to the contact person ( *See**FOR FURTHER INFORMATION CONTACT* ). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard; (2) any reference number and date; (3) name and address of the national or international standards development organization; (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply; and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

**VI. Electronic Access**

You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the  Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the *Federal Register* , this notice announcing “Modification to the List of Recognized Standards, Recognition List Number: 026” will be available on the CDRH home page. You may access the CDRH home page at *http://www.fda.gov/MedicalDevices.*

You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” at *http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.*

This *Federal Register* document on modifications in FDA's recognition of consensus standards is available at *http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.*

**VII. Submission of Comments and Effective Date**

Interested persons may submit to the contact person ( *see**FOR FURTHER INFORMATION CONTACT* ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 026. These modifications to the list or recognized standards are effective upon publication of this notice in the *Federal Register.*

Dated: March 8, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.