Skip to Content

Notice

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

Document Details

Information about this document as published in the Federal Register.

Enhanced Content

Relevant information about this document from Regulations.gov provides additional context. This information is not part of the official Federal Register document.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

Start Preamble

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: standards@cdrh.fda.gov. 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.

Start Further Info

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:

Table 1—Previous Publications of Standard Recognition Lists

February 25, 1998 (63 FR 9561).
October 16, 1998 (63 FR 55617).
July 12, 1999 (64 FR 37546).
November 15, 2000 (65 FR 69022).
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).
Start Printed Page 13632

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.

Table 2—Modifications to the List of Recognized Standards

Old recognition No.Replacement recognition No.Title of standard 1Change
A. Anesthesia
1-56CGA V-7.1 1997 (R2003) (2008) Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases—First EditionReaffirmation.
B. Biocompatibility
2-962-162ASTM F1903-10 Standard Practice for Testing For Biological Responses to Particles In VitroWithdrawn and replaced with newer version.
2-117ANSI/AAMI/ISO 10993-3:2003/(R)2009 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicityExtent of recognition.
C. Cardiovascular
3-54ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular implants—Tubular vascular prosthesesReaffirmation.
3-58ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implants—Cardiac valve prosthesesReaffirmation.
3-66ASTM F 2081-06 Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular StentsDevice affected, Processes impacted, Type of standard, CFR citation and product codes, and Contact person.
D. Dental/ENT
4-89ADA Specification No. 53 Polymer-Based Crowns and Bridge ResinsReaffirmation.
4-111ADA Specification No. 13 Denture Cold-Curing Repair Resins: 1981 (Reaffirmed 2006)Withdrawn.
4-112ADA Specification No. 16 Dental Impression Paste—Zinc Oxide Eugenol TypeWithdrawn.
4-1244-191ANSI/ASA S3.22-2009 American National Standard Specification of Hearing Aid CharacteristicsWithdrawn and replaced with newer version.
4-1274-192ADA Specification 58 Root Canal Files, Type H (Hedstrom) 2007Withdrawn and replaced with newer version.
4-1384-193ADA Specification No. 15 Artificial Teeth for Dental ProsthesesWithdrawn and replaced with newer version.
4-1484-194ADA Specification No. 78 Dental Obturating ConesWithdrawn and replaced with newer version.
4-158ISO 10139-1:2005 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Technical Corrigendum 1:2006Withdrawn duplicate. See 4-189.
E. General Hospital/General Plastic Surgery
6-1446-243ASTM D5712-10 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry MethodWithdrawn and replaced with a newer version.
6-145ASTM D3578-05 Standard Specification for Rubber Examination GlovesReaffirmation.
6-149ASTM D7160-05 (Reapproved 2010) Standard Practice for Determination of Expiration Dating for Medical GlovesReaffirmation.
Start Printed Page 13633
6-150ASTM D7161-05 (Reapproved 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse ConditionsReaffirmation.
6-165ASTM D6977-04 (Reapproved 2010) Standard Specification for Polychloroprene Examination Gloves for Medical ApplicationReaffirmation.
6-1676-244ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical ApplicationWithdrawn and replaced with newer version.
6-169ASTM D3772-01 (Reapproved 2010) Standard Specification for Natural Rubber Finger CotsReaffirmation.
6-2016-245ISO 8536-4 Fifth edition 2010-10-01 Infusion equipment for medical use—Part 4: Infusion sets for single use, gravity feedWithdrawn and replaced with newer version.
6-2186-246USP 33-NF 28 2010 <11> Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
6-2206-247USP 33-NF 28 2010 Absorbable Surgical SutureWithdrawn and replaced with newer version.
6-2216-248USP 33-NF 28 2010 <881> Tensile StrengthWithdrawn and replaced with newer version.
6-2226-249USP 33-NF 28 2010 <861> Suture-DiameterWithdrawn and replaced with newer version.
6-2236-250USP 33-NF 28 2010 <871> Sutures—Needle AttachmentWithdrawn and replaced with newer version.
6-2246-251USP 33 NF-28 2010 <11> Sterile Water for IrrigationWithdrawn and replaced with newer version.
6-2256-252USP 33 NF-28 2010 <11> Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
F. IVD
7-183CLSI M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous FungiWithdrawn duplicate. See 7-171.
7-1887-218CLSI M45-A2 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline—Second EditionWithdrawn and replaced with newer version.
G. Materials
8-10ASTM F603-00 Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant ApplicationWithdrawn.
8-888-195ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsWithdrawn and replaced with newer version.
8-101ASTM F 2118—03 (Reapproved 2009) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement MaterialsReaffirmation.
8-103ASTM F1801—97 (Reapproved 2009)ε1 Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsReaffirmation.
8-107ASTM F746—04 (Reapproved 2009)ε1 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsReaffirmation.
8-117ASTM F86—04 (Reapproved 2009) Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsReaffirmation.
H. OB-GYN/Gastroenterology
9-47AAMI RD16 Cardiovascular implants and artificial organs—Hemodialyzers, hemodiafiltersWithdrawn. See 9-65.
9-48AAMI RD17 Cardiovascular implants and artificial organs—Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofiltersWithdrawn. See 9-66.
9-50ANSI/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 haemodialysisReaffirmation.
9-519-65ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal systems—Hemodialyzers, hemodiafilters, hemofilters and hemoconcentratorsWithdrawn and replaced with newer version.
9-529-66ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and extracorporeal systems—Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofiltersWithdrawn and replaced with newer version.
9-55ANSI/AAMI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009 Water treatment equipment for haemodialysis applicationsReaffirmation.
Start Printed Page 13634
I. Orthopedics
11-168ASTM F 1781-03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint ImplantsReaffirmation.
11-183ASTM F1875-98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper InterfaceReaffirmation.
J. Physical Medicine
16-3016-167ISO 7176-9: Third edition, 2009-11-15 Wheelchairs—Part 9: Climatic tests for electric wheelchairsWithdrawn and replaced with newer version.
16-3116-168RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1: Determination of static stabilityWithdrawn and replaced with newer version.
16-3216-169RESNA 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 wheelchairsWithdrawn and replaced with newer version.
16-3316-170RESNA 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 brakesWithdrawn and replaced with newer version.
16-3416-171RESNA 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 rangeWithdrawn and replaced with newer version.
16-3516-172RESNA 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 spaceWithdrawn and replaced with newer version.
16-3616-173RESNA 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 wheelchairsWithdrawn and replaced with newer version.
16-3716-174RESNA 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 DimensionsWithdrawn and replaced with newer version.
16-3816-175RESNA 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 strengthsWithdrawn and replaced with newer version.
16-3916-176RESNA 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 wheelchairsWithdrawn and replaced with newer version.
16-4016-177RESNA 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 wheelchairsWithdrawn and replaced with newer version.
16-4116-178RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummiesWithdrawn and replaced with newer version.
16-4216-179RESNA 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 surfacesWithdrawn and replaced with newer version.
16-4316-180RESNA 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 methodsWithdrawn and replaced with newer version.
16-4416-181RESNA 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 labelingWithdrawn and replaced with newer version.
Start Printed Page 13635
16-4516-182RESNA 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 methodsWithdrawn and replaced with newer version.
16-4616-183RESNA 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 wheelchairsWithdrawn and replaced with newer version.
16-4716-184RESNA WC-1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 22: Set-up proceduresWithdrawn and replaced with newer version.
16-48ANSI/RESNA WC/Volume 1-1998, Section 93: Maximum Overall DimensionsWithdrawn.
16-49ANSI/RESNA WC/Volume 1-1998, Section 0: Nomenclature, Terms, and DefinitionsWithdrawn.
16-16016-185RESNA 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 scootersWithdrawn and replaced with newer version.
16-16116-186ASME A18.1-2008 (Revision of ASME A18.1-2005) Safety Standard for Platform Lifts and Stairway ChairliftsWithdrawn and replaced with newer version.
K. Radiology
12-12212-217IEC 62083 Edition 2.0:2009-09 Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systemsWithdrawn and replaced with newer version.
12-36IEC 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.
12-18312-218NEMA PS 3.1—3.18 (2009) Digital Imaging and Communications in Medicine (DICOM) SetWithdrawn and replaced with newer version.
L. Software/Informatics
13-4UL 1998 Standard for Safety Software in Programmable Components, Second EditionReaffirmation.
M. Sterility
14-26514-301USP 33:2010 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
14-26614-302USP 33: 2010 <71> Sterility TestsWithdrawn and replaced with newer version.
14-26714-303USP 33:2010 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
14-26814-304USP 33:2010 <151> Pyrogen TestWithdrawn and replaced with newer version.
14-26914-305USP 33:2010 <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version.
14-27014-306USP 33:2010 Biological Indicators for Steam Sterilization, Self-ContainedWithdrawn and replaced with newer version.
14-27114-307USP 33:2010 Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-27214-308USP 33:2010 Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-27314-309USP 33:2010 Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-27814-310USP 33:2010 <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
1 All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 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.Start Printed Page 13636

Table 3—New Entries to the List of Recognized Standards

Recognition No.Title of standard 1Reference No. and date
A. Anesthesia
1-84Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Paediatric tracheostomy tubes TECHNICAL CORRIGENDUM 1ISO 5366-3:2001 TECHNICAL CORRIGENDUM 1.
B. Biocompatibility
2-163Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation productsANSI/AAMI/ISO 10993-9:2009.
2-164Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devicesANSI/AAMI/ISO 10993-13:2010.
2-165Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramicsANSI/AAMI/ISO 10993-14:2001.
2-166Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachablesANSI/AAMI/ISO 10993-16:2010.
2-167Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materialsISO/TS 10993-19 First edition 2006-06-01.
2-168Biological evaluation of medical devices— Part 9: Framework for identification and quantification of potential degradation productsISO 10993-9 Second edition 2009-12-15.
2-169Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devicesISO 10993-13 First edition 1998-11-15.
2-170Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramicsISO 10993-14 First edition 2001-11-15.
2-171Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachablesISO 10993-16 Second edition 2010-02-15.
2-172Biological evaluation of medical devices—Part 19: Physico-chemical, morphological, and topographical characterization of materialsANSI/AAMI/ISO TIR10993-19:2006.
C. Cardiovascular
3-83Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devicesANSI/AAMI/ISO 14708-5:2010.
3-84Cardiovascular implants—Endovascular devices—Part 1: Endovascular prostheses Amendment 1: Test methodsANSI/AAMI/ISO 25539-1:2003/A1:2005/(R)2009.
3-85Cardiovascular implants—Endovascular devices—Part 2: Vascular stentsANSI/AAMI/ISO 25539-2:2008.
3-86Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery SystemASTM F 2394-07.
3-87Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular StentsASTM F 2477-07.
3-88Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial LoadingASTM F 2514-08.
3-89Active implantable medical devices—Four-pole connector system for implantable cardiac rhythm management devices—Dimensional and test requirementsISO 27186 First edition 2010-03-15.
3-90Cardiovascular implants—Tubular vascular prosthesesISO 7198 First edition 1998-08-01.
3-91Cardiovascular implants—Cardiac valve prosthesesISO 5840 Fourth edition 2005-03-01.
3-92Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devicesISO 14708-5 First edition 2010-02-01.
3-93Cardiovascular implants—Endovascular device—Part 1: Endovascular prostheses AMENDMENT 1: Test methodsISO 25539-1 First edition 2001-11-13 AMENDMENT 1 2005-07-15.
3-94Cardiovascular implants—Endovascular devices—Part 2: Vascular stentsISO 25539-2 First edition 2008-09-01.
D. General
5-63Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirementsISO 80369-1 First edition 2010-12-15.
5-64Small bore connectors for liquids and gases in healthcare applications—Part 1: General requirementsAAMI/ISO/FDS-1 80369-01 2010.
E. Materials
8-196Implants for surgery—Metallic materials—Part 1: Wrought stainless steel TECHNICAL CORRIGENDUM 1ISO 5832-1:2007 TECHNICAL CORRIGENDUM 1 2008-04-15.
8-197Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1ISO 5832-12:2007 TECHNICAL CORRIGENDUM 1 2008-09-15.
8-198Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical ImplantsASTM F 2102-06ε1.
Start Printed Page 13637
8-199Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical ImplantsASTM F 2633-07.
8-200Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in AirASTM F 2003-02 (Reapproved 2008).
8-201Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)ASTM F 2214-02 (Reapproved 2008).
8-202Standard Test Method for Small Punch Testing of Ultra-High Molecular Weight Polyethylene Used in Surgical ImplantsASTM F 2183-02 (Reapproved 2008).
F. Nanotechnology
18-1Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)ASTM E 2490-09.
G. Ophthalmic
10-62Ophthalmics—Ophthalmic Instruments—TonometersANSI Z80.10-2009.
10-63Ophthalmic implants—Intraocular lenses—Guidance on assessment of the need for clinical investigation of intraocular lens design modificationsISO/TR 22979-2006.
H. Radiology
12-219Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots CORRIGENDUM 1IEC 60336 (Fourth edition—2005).
12-220Safety of laser products—Part 1: Equipment classification and requirements CORRIGENDUM 1IEC 60825-1 (Second edition—2007).
12-221Evaluation and routine testing in medical imaging departments—Part 3-4: Acceptance tests—Imaging performance of dental X-ray equipmentIEC 61223-3-4 First edition 2000-03.
12-222Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipmentIEC 61223-3-5 First edition 2004-08.
12-223Evaluation and routine testing in medical imaging departments—Part 3-5: Acceptance tests—Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1IEC 61223-3-5 (First edition 2004).
12-224Medical electrical equipment—Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1IEC 60601-2-44 (Third edition—2009).
12-225Computed Tomography Dose CheckNEMA XR 25 2010.
12-226Evaluation and routine testing in medical imaging departments—Part 2-6: Constancy tests—Imaging performance of computed tomography X-ray equipmentIEC 61223-2-6 Second edition 2006-11.
I. Tissue Engineering
15-25ASTM F2312—10 Standard Terminology Relating to Tissue Engineered Medical ProductsASTM F2312-10.
15-26ASTM F2211—04 Standard Classification for Tissue Engineered Medical Products (TEMPs)ASTM F2211-04.
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 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 Start Printed Page 13638Internet 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.

Start Signature

Dated: March 8, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.

End Signature End Further Info End Preamble

[FR Doc. 2011-5815 Filed 3-11-11; 8:45 am]

BILLING CODE 4160-01-P