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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 028

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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: 028” (Recognition List Number: 028), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

Submit either electronic or written 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: 028” 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 electronic comments concerning this document to standards@cdrh.fda.gov. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). 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: 028 modifications and other standards related information.

FOR FURTHER INFORMATION CONTACT:

Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3628, 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 of this document.

Table 1—Previous Publication 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)
March 14, 2011 (76 FR 13631)
August 2, 2011 (76 FR 46300)

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: 028

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: 028” 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
1-15ISO 5361-4 Second edition 1987-12-15 Tracheal tubes—Part 4: Cole typeContact person.
1-18ISO 8359 Second edition 1996-12-15 Oxygen concentrators for medical use—Safety requirementsContact person.
1-35ISO 5361 First edition 1999-09-15 Corrected and reprinted 1999-12-15 Anaesthetic and respiratory equipment—Tracheal tubes and connectorsContact person.
1-36ISO 5366-3 Second edition 2001-08-15 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Pediatric tracheostomy tubesContact person.
1-44ISO 5366-1 Fourth edition 2000-12-15 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adultsContact person.
1-46ISO 5367 Fourth edition 2000-06-01 Breathing tubes intended for use with anaesthetic apparatus and ventilatorsContact person.
1-56CGA V-7.1:1997 (Reaffirmed 2008) Standard Method of Determining Cylinder Valve Outlet Connections for Medical GasesContact person.
1-57ASTM F1101-90 (Reapproved 2003) 1 Standard Specification for Ventilators Intended for Use During AnesthesiaContact person.
1-58ASTM G175-03 (Reapproved 2011) Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency ApplicationsReaffirmation.
1-60IEC 60601-2-12 [ISO 10651-1] Second edition 2001-10 Medical electrical equipment—Part 2-12: Particular requirements for the safety of lung ventilators—Critical care ventilatorsContact person.
1-62ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment—Conical connectors: Part 1: Cones and socketsContact person.
1-69ASTM F 1464-93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary UseContact person.
1-70ASTM F 1246-91 (Reapproved 2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator CircuitsContact person.
1-72ISO 10651-5 First edition 2006-02-01 Lung ventilators for medical use—Particular requirements for basic safety and essential performance—Part 5: Gas-powered emergency resuscitatorsContact person.
1-73ISO 10651-4 First edition 2002-03-01 Lung ventilators—Part 4: Particular requirements for operator-powered resuscitatorsContact person.
1-75ISO 5362 Fourth edition 2006-06-01 Anaesthetic reservoir bagsContact person.
1-79ISO 26825 First edition 2008-08-15 Corrected version 2009-09-15 Anaesthetic and respiratory equipment—User-applied labels for syringes containing drugs used during anaesthesia—Colours, design and performanceContact person.
B. Biocompatibility
2-872-174ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitizationWithdrawn and replaced with newer version.
2-93ASTM F763-04 (Reapproved 2010) Standard Practice for Short-Term Screening of Implant MaterialsReaffirmation.
2-94ASTM F981-04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and BoneReaffirmation.
2-108ASTM F1905-98 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause ImmunotoxicityWithdrawn.
2-114ASTM F1877-05 (Reapproved 2010) Standard Practice for Characterization of ParticlesReaffirmation.
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 and Contact person.
2-118ANSI/AAMI/ISO 10993-11:2006/(R)2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicityReaffirmation.
2-120ANSI/AAMI/ISO 10993-6:2007/(R)2010 Biological evaluation of medical devices—Part 6: Tests for local effects after implantationReaffirmation.
2-126ASTM F748-06 (Reapproved 2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesReaffirmation.
2-134ASTM F2065-00 (Reapproved 2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid MaterialsReaffirmation.
2-155ASTM F2147-01 (Reapproved 2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact AllergensReaffirmation.
2-1572-184USP34-NF29:2011<87> Biological Reactivity Tests, In Vitro—Direct Contact TestWithdrawn and replaced with newer version.
2-1582-185USP 34-NF29:2011 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version.
2-1592-186USP 34-NF29:2011 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of SampleWithdrawn and replaced with newer version.
2-1602-187USP 34-NF29:2011 Biological Tests <88> Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous TestWithdrawn and replaced with newer version.
2-1612-188USP 34-NF29:2011 Biological Tests <88> Biological Reactivity Tests, In Vivo Classification of Plastics—Systemic Injection TestWithdrawn and replaced with newer version.
2-165ANSI/AAMI/ISO 10993-14:2001 (Reapproved 2006) Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramicsReaffirmation.
2-1662-180ANSI/AAMI/ISO 10993-16:2010 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachablesWithdrawn and replaced with newer version.
C. Cardiovascular
3-52ANSI/AAMI EC12:2000/(R)2010 Disposable ECG electrodesReaffirmation.
3-613-95IEC 60601-2-27 Edition 3.0 2011-03 Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentNewer version with transition period.
D. Dental/ENT
4-76ISO 7785-2 Second edition 1995-08-01 Dental handpieces—Part 2: Straight and geared angle handpiecesContact person.
4-83ISO 11498 First edition 1997-02-15 Dental handpieces—Dental low-voltage electrical motorsContact person.
4-84ISO 13294 First edition 1997-05-01 Dental handpieces—Dental air-motorsContact person.
4-90ANSI S3.39 Reaffirmed by ANSI May 18, 2007 Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)Contact person.
4-119ANSI/ADA Specification No. 82-1998 (R2009) Reversible/Irreversible Hydrocolloid Impression Material SystemsReaffirmation.
4-121ISO 7494-2 First edition 2003-03-01 Dentistry—Dental units—Part 2: Water and air supplyContact person.
4-123ANSI/ASA S3.6-2004 Specification for AudiometersContact person.
4-126ISO 10477 Second edition 2004-10-01 Dentistry—Polymer-based crown and bridge materialsContact person.
4-134ISO 7494-1 First edition 2004-08-15 Dentistry—Dental units—Part 1: General requirements and test methodsContact person.
4-136ASTM Designation: F2504-05 Standard Practice for Describing System Output of Implantable Middle Ear Hearing DevicesContact person.
4-150ANSI/ADA Specification No. 19-2003 Dental Elastometric Impression Material:2003Contact person.
4-154ISO 4823 Third edition 2000-12-15 Dentistry—Elastometric impression materialsContact person.
4-155ISO 4823:2000 Technical Corrigendum 1 Published 2004-07-15 Dentistry—Elastomeric impression materialsContact person.
4-156ISO 4823 Third edition 2000-12-15 Amendment 1 2007-07-01 Dentistry—Elastometric impression materialsContact person.
4-160ANSI S3.1-1999 (Reaffirmed by ANSI October 28, 2008) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test RoomsContact person.
4-162ANSI S3.4-2007 American National Standard Procedure for the Computation of Loudness of Steady SoundsContact person.
4-163ANSI S3.5-1997 (R1986) Reaffirmed by ANSI May 18, 2007 American National Standard Methods for Calculation of the Speech Intelligibility IndexContact person.
4-164ANSI S3.7-1995 (Reaffirmed by ANSI October 28, 2008) American National Standard Method for Coupler Calibration of EarphonesContact person.
4-165ANSI S3.13-1987 Reaffirmed by ANSI June 1, 2007 American National Standard Mechanical Coupler for Measurement of Bone VibratorsContact person.
4-170ANSI S3.36-1985 Reaffirmed by ANSI on 4/27/2006 American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic MeasurementsContact person.
4-171ANSI S3.37-1987 (Reaffirmed by ANSI May 18, 2007) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing AidsContact person.
4-172ANSI S3.42-1992 Reaffirmed by ANSI May 18, 2007 American National Standard Testing Hearing Aids with a Broad-Band Noise SignalContact person.
4-173ANSI S3.44-1996 Reaffirmed by ANSI on 27 April 2006 American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing ImpairmentContact person.
4-175ANSI S3.46-1997 American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing AidsContact person.
4-177ANSI S12.65-2006 (Reaffirmed by ANSI March 30, 2011) American National Standard For Rating Noise with Respect to Speech InterferenceReaffirmation.
4-179ISO 7405 Second edition 2008-12-15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistryContact person.
4-180ISO 9168 Third edition 2009-07-15 Dentistry—Hose connectors for air driven dental handpiecesContact person.
4-183ANSI S3.2-2009 American National Standard Method for Measuring the Intelligibility of Speech over Communication SystemsContact person.
4-184ANSI/ASA S3.25-2009 American National Standard For an Occluded Ear SimulatorContact person.
4-185ANSI/ASA S3.45-2009 American National Standard Procedures for Testing Basic Vestibular FunctionContact person.
4-186ANSI/ASA S12.2-2008 American National Standard Criteria for Evaluating Room NoiseContact person.
4-190ANSI/ASA S3.35-2010 American National Standard Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working ConditionsContact person.
4-192ANSI/ADA Specification No. 58-2010 Root Canal Files Type H (Hedstrom): 2007Contact person.
E. General
5-29AAMI/ANSI HE74-2001 (R 2009) Human factors design process for medical devicesWithdrawn, see 5-67.
5-39IEC 60812 Second edition 2006-01 Analysis techniques for system reliability—Procedure for failure mode and effects analysis (FMEA)Contact person.
5-40ISO 14971 Second edition 2007-03-01 Medical devices—Application of risk management to medical devicesContact person.
5-42ASTM D903-98 (Reapproved 2010) Standard Test Methods for Peel or Stripping Strength of Adhesive BondsReaffirmation.
5-58IEC 60601-1-11 Edition 1.0:2010 Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environmentExtent of recognition and relevant guidance.
F. General Hospital/General Plastic Surgery
6-117ASTM F2172-02(2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid WarmersReaffirmation and Contact person.
6-161ISO 10555-1 First edition 1995-06-15 Sterile, Single-use intravascular catheters—Part 1: General requirementsTitle and Contact person.
6-164ISO 10555-5 First edition 1996-06-15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral cathetersTitle and Contact person.
6-1646-266ISO 10555-5 First edition 1996-06-15 AMENDMENT 1 1999-01-15 Corrected and reprinted 1999-07-15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral cathetersSee 6-164.
6-1646-267ISO 10555-5:1996 TECHNICAL CORRIGENDUM 1 Published 2002-06-15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters TECHNICAL CORRIGENDUMSee 6-164.
6-176ASTM D7103-06 1 Standard Guide for Assessment of Medical GlovesEditorial change.
6-177ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient TemperatureReaffirmation.
6-1986-254ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face MasksWithdrawn and replaced with newer version.
6-203ASTM D6499-07, Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its ProductsExtent of recognition.
6-2196-255USP 34-NF 29<11>:2011 Sodium Chloride IrrigationWithdrawn and replaced with newer version.
6-2266-256USP 34-NF 29<11>:2011 Sodium Chloride InjectionWithdrawn and replaced with newer version.
6-2466-257USP 34-NF 29 2011 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version.
6-2486-258USP 34-NF 29 2011 <881> Tensile StrengthWithdrawn and replaced with newer version.
6-2496-259USP 34-NF 29 2011 <861> Sutures DiameterWithdrawn and replaced with newer version.
6-2506-260USP 34-NF 29 2011 <871> Sutures—NeedleWithdrawn and replaced with newer version.
6-2516-261USP 34-NF 29 <11>:2011 Sterile Water for IrrigationWithdrawn and replaced with newer version.
6-2526-262USP 34-NF 29 <11>:2011 Heparin Lock Flush SolutionWithdrawn and replaced with newer version.
G. In Vitro Diagnostics
7-1027-221CLSI H01-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth EditionWithdrawn and replaced with newer version.
7-112CLSI H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved GuidelineWithdrawn duplicate, see 7-162.
7-1267-222CLSI M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standards—Second EditionWithdrawn and replaced with newer version Contact person.
7-128CLSI EP14-A2 Evaluation of Matrix Effects; Approved Guideline—Second EditionWithdrawn duplicate, see 7-143.
7-130CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second EditionWithdrawn duplicate, see 7-165.
7-134CLSI GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second EditionWithdrawn duplicate, see 7-166.
7-1407-223GP22-A3—Quality Management System: Continual Improvement; Approved Guideline—Third EditionWithdrawn and replaced with newer version.
7-143CLSI EP14-A2 Evaluation of Matrix Effects; Approved Guideline—Second EditionContact person, Type of standard, Processes impacted.
7-147CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third EditionWithdrawn duplicate, see 7-178.
7-150CLSI H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second EditionTitle, Contact person.
7-162CLSI H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved GuidelineContact person, Devices affected, Processes affected, Type of standard, CFR citation and product codes.
7-165CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second EditionContact person, Devices affected, Processes affected, Type of standard, CFR citation and product codes.
7-166CLSI GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second EditionDevices affected, Process affected, CFR citation and product codes.
7-169CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third EditionWithdrawn duplicate, see 7-204.
7-172CLSI C28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third EditionWithdrawn duplicate, see 7-224.
7-2027-224CLSI C28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third EditionWithdrawn and replaced with newer version.
7-178CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third EditionExtent of recognition, CFR citation and product codes.
7-204CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third EditionContact person.
7-206CLSI I/LA 20-A2 Analytical Performance Characteristics and Clinical Utility of Immunological Assays for Human Immunoglobulin E (IgE) Antibodies and Defined Allergen Specificities; Approved Guideline—Second EditionTitle, Contact person.
H. Materials
11-2198-203ASTM F2026-08 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant ApplicationsTransferred.
8-1018-204ASTM F2118-10 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement MaterialsWithdrawn and replaced with newer version.
8-1058-205ASTM F1635-11 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical ImplantsWithdrawn and replaced with newer version.
8-114ASTM F2255-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension LoadingReaffirmation.
8-115ASTM F2256-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension LoadingReaffirmation.
8-116ASTM F2258-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in TensionReaffirmation.
8-1198-206ASTM F688-10 Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035)Withdrawn and replaced with newer version.
8-121ASTM F2005-05 (Reapproved 2010) Standard Terminology for Nickel-Titanium Shape Memory AlloysReaffirmation.
8-125ASTM F2004-05 (Reapproved 2010) Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal AnalysisReaffirmation.
8-126ASTM F561-05a (Reapproved 2010) Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and FluidsReaffirmation.
8-132ASTM F1088-04a (Reapproved 2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationReaffirmation and contact person.
8-135ASTM F2392-04 (Reapproved 2010) Standard Test Method for Burst Strength of Surgical SealantsReaffirmation.
8-136ASTM F2458-05 (Reapproved 2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and SealantsReaffirmation.
8-1728-207ASTM F1926/F1926M-10 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and CoatingsWithdrawn and replaced with newer version.
8-1788-208ASTM F648-10a Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsWithdrawn and replaced with newer version.
8-1818-209ASTM F899-11 Standard Specification for Wrought Stainless Steels for Surgical InstrumentsWithdrawn and replaced with newer version.
8-1918-210ASTM F2182-11 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance ImagingWithdrawn and replaced with newer version.
8-195ASTM F2024-10, Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsExtent of Recognition, devices affected, CFR citations and associated procodes and contact person.
I. Neurology
17-1ANSI/AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring devicesReaffirmation.
17-3ISO 7197:2006 Third edition 2006-06-01 Neurosurgical implants—Sterile, single-use hydrocephalus shunts and componentsContact person.
17-4ASTM F 647-94 (Reapproved 2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical ApplicationContact person.
17-7ISO 7197:2006 Technical Corrigendum 1 Published:2007-07-01 Neurological implants—Sterile, single-use hydrocephalus shunts and componentsContact person.
J. OB-GYN/Gastroenterology
9-21ISO 8600-4 First edition 1997-07-01 Optics and optical instruments—Medical endoscopes and certain accessories—Part 4: Determination of maximum width of insertion portionContact person.
9-37ISO 8600-1 Second edition 2005-05-01 Optics and photonics—Medical endoscopes and endotherapy devices—Part 1: General requirementsContact person.
9-38ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 2003-12-01 Optics and optical instruments—Medical endoscopes and endoscopic accessories Part 3: Determination of field of view and direction of view of endoscopes with opticsContact person.
9-39ISO 8600-5 First edition 2005-03-15 Optics and photonics—Medical endoscopes and endotherapy devices—Part 5: Determination of optical resolution of rigid endoscopes with opticsContact person.
9-40ISO 8600-6 First edition 2005-03-15 Optics and photonics—Medical endoscopes and endotherapy devices—Part 6: VocabularyContact person.
9-44ASTM Designation: F 623-99 (Reapproved 2006) Standard Performance Specification for Foley CatheterContact person.
9-49AAMI/ANSI RD61:2006, Concentrates for hemodialysisWithdrawn, see 9-73.
9-50ANSI/AAMI RD52:2004/(R)2010 Dialysate for HemodialysisWithdrawn, see 9-70 and 9-71.
9-53ASTM F 1992-99 (Reapproved 2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible EndoscopesContact person.
9-55AAMI/ANSI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009, Water treatment equipment for hemodialysis applicationsWithdrawn, see 9-69.
9-61IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmentContact person.
9-59AAMI/ANSI RD5:2003/(R)2008, HemodialysisWithdrawn, see 9-72.
K. Ophthalmic
10-15ISO 9394 Second edition 1998-08-15 Ophthalmic optics—Contact lenses and contact lens care products—Determination of biocompatibility by ocular study using rabbit eyesContact person.
10-2410-67ISO 11986 Second edition 2010-11-01 Ophthalmic optics—Contact lenses and contact lens care products—Determination of preservative uptake and releaseWithdrawn and replaced with newer version.
10-2610-68ISO 13212 Second edition 2011-05-15 Ophthalmic optics—Contact lens care products—Guidelines for determination of shelf-lifeWithdrawn and replaced with newer version.
10-28ISO 14729 First edition 2001-04-15 Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lensesContact person.
10-29ISO 14730 First edition 2000-09-15 Ophthalmic optics—Contact lens care products—Antimicrobial preservative efficacy testing and guidance on determining discard dateContact person.
10-3310-69ANSI Z80.18-2010 for Ophthalmics—Contact Lens Care Products—Vocabulary, Performance Specifications, and Test MethodologyWithdrawn and replaced with newer version.
10-3810-70ISO 10943 Third edition 2011-08-15 Ophthalmic instruments—Indirect ophthalmoscopesWithdrawn and replaced with newer version.
10-59ISO 11980 Second edition 2009-10-15 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigationsContact person.
L. Orthopedic
11-16711-226ASTM F1089-10 Standard Test Method for Corrosion of Surgical InstrumentsWithdrawn and replaced with newer version.
11-18011-227ASTM F366-10 Standard Specification for Fixation Pins and WiresWithdrawn and replaced with newer version; change contact.
11-196ASTM F1672-95 (Reapproved 2011) Standard Specification for Resurfacing Patellar ProsthesisReaffirmation.
11-20111-228ASTM F564-10 Standard Specification and Test Methods for Metallic Bone StaplesWithdrawn and replaced with newer version.
11-21711-229ASTM F2083-10 Standard Specification for Total Knee ProsthesisWithdrawn and replaced with newer version.
11-22111-230ASTM F1717-10 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelWithdrawn and replaced with newer version.
11-15511-231ISO 7207-2 Second edition 2011-07-01 Implants for surgery—Components for partial and total knee joint prostheses—Part 2: Articulating surfaces made of metal, ceramic and plastics materialsWithdrawn and replaced with newer version.
11-2198-203ASTM F2026-10 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant ApplicationsTransferred and replaced with a newer version.
M. Radiology
12-52UL 544 (1998), Standard for Medical and Dental Equipment—Ed. 4.0Withdrawn, see 5-4 and 5-52.
12-62UL 187 (1998), Standard for X-ray Equipment—Ed. 7.0Withdrawn, see 5-4 and 5-52.
12-100NEMA UD 3-2004 (R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2Reaffirmation.
12-105NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3Reaffirmation.
12-106ISO 17526 First edition 2003-06-15, Optics and optical instruments—Lasers and laser-related equipment—Lifetime of lasersContact person.
12-10812-246ISO 21254-2 First edition 2011-07-15 Lasers and laser-related equipment—Test methods for laser-induced damage threshold—Part 2: Threshold determinationWithdrawn and replaced with newer version.
12-10912-245ISO 21254-1 First edition 2011-07-15 Lasers and laser-related equipment—Test methods for laser-induced damage threshold—Part 1: Definitions and general principlesWithdrawn and replaced with newer version.
12-110ISO 11551 Second edition 2003-12-01, Optics and optical instruments—Lasers and laser-related equipment—Test method for absorptance of optical laser componentsContact person.
12-113ISO 12005 Second edition 2003-04-01, Lasers and laser-related equipment—Test methods for laser beam parameters—PolarizationContact person.
12-115ISO 13695 First edition 2004-06-01, Optics and photonics—Lasers and laser-related equipment—Test methods for the spectral characteristics of lasersContact person.
12-117ISO 15367-1 First edition 2003-09-15, Lasers and laser-related equipment—Test methods for determination of the shape of a laser beam wavefront—Part 1: Terminology and fundamental aspectsContact person.
12-134ISO 11146-1 First edition 2005-01-15, Lasers and laser-related equipment—Test methods for laser beam widths, divergence angles and beam propagation ratios—Part 1: Stigmatic and simple astigmatic beamsContact person.
12-140AIUM RTD2-2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2Title.
12-142ISO 11146-2 First edition 2005-02-15, Lasers and laser-related equipment—Test methods for laser beam widths, divergence angles and beam propagation ratios—Part 2: General astigmatic beamsContact person.
12-143ISO 15367-2 First edition 2005-03-15, Lasers and laser-related equipment—Test methods for determination of the shape of a laser beam wavefront—Part 2: Shack-Hartman sensorsContact person.
12-14412-247ISO 11990-1 First edition 2011-08-01 Lasers and laser-related equipment—Determination of laser resistance of tracheal tubes—Part 1: Tracheal tube shaftWithdrawn and replaced with newer version.
12-15412-248ISO 21254-3 First edition 2011-07-15 Lasers and laser-related equipment—Test methods for laser-induced damage threshold—Part 3: Assurance of laser power (energy) handling capabilitiesWithdrawn and replaced with newer version.
12-155ISO 11554 Third edition 2006-05-01, Optics and photonics—Lasers and laser-related equipment—Test methods for laser beam power, energy and temporal characteristicsContact person.
12-156ISO 11670:2003 Technical Corrigendum 1 Published 2004-05-15, Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stabilityContact person.
12-157ISO 13694:2000 Technical Corrigendum 1 Published 2005-11-01, Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power (energy) density distributionContact person.
12-174ISO 13697 First edition 2006-05-15, Optics and photonics—Lasers and laser-related equipment—Test methods for specular reflectance and regular transmittance of optical laser componentsContact person.
12-175ISO 24013 First edition 2006-11-15, Optics and photonics—Lasers and laser-related equipment—Measurement of phase retardation of optical components for polarized laser radiationContact person.
12-17712-249ANSI/UL 122-2007 Standard for Photographic Equipment—Ed. 5.0Withdrawn and replaced with newer version.
12-12512-231NEMA MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic Resonance ImagingWithdrawn and replaced with newer version.
12-15112-232NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging DevicesWithdrawn and replaced with newer version.
12-16012-234NEMA MS 12-2010, Quantification and Mapping of Geometric Distortion for Special ApplicationsWithdrawn and replaced with newer version.
12-16212-235IEC 60731 Edition 3.0 2011-02, Amendment 1, Medical electrical equipment—Dosimeters with ionization chambers as used in radiotherapyWithdrawn and replaced with newer version.
12-17812-236IEC 60601-2-45 Edition 3.0 2011-02, Medical electrical equipment—Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devicesNewer version with transition period.
12-19112-237IEC 62359 Edition 2.0 2010-10, Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fieldsWithdrawn and replaced with newer version.
12-21812-238NEMA PS 3.1-3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) SetWithdrawn and replaced with newer version.
N. Software/Informatics
13-1113-30CLSI AUTO3-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard, Second Edition 2009Withdrawn and replaced with newer version.
O. Sterility
14-135AAMI/ANSI ST63:2002, Sterilization of health care products—Requirements for the development, validation and routine control of an industrial sterilization process for medical devices—Dry heatWithdrawn, see 14-339.
14-169ASTM F2391-05 (Reapproved 2011) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer GasReaffirmation.
14-17014-313ASTM F2475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging MaterialsWithdrawn and replaced with newer version.
14-181ANSI/AAMI ST58:2005/(R)2010 Chemical sterilization and high-level disinfection in health care facilitiesReaffirmation and contact person.
14-193ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systemsReaffirmation.
14-194ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processesReaffirmation.
14-195ANSI/AAMI/ISO 11140-1:2005(R)2010 Sterilization of health care products—Chemical indicators—Part 1: General requirementsReaffirmation, extent of recognition, and type of standard.
14-201ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilizationReaffirmation and contact person.
14-214AOAC 6.2.04:2009 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use—Dilution MethodReaffirmation.
14-216AOAC 6.2.06:2009 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use—Dilution MethodReaffirmation.
14-219AOAC 6.3.06:2008 Official Method 965.12, Tuberculocidal Activity of DisinfectantsReaffirmation.
14-222ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care products—Biological and chemical indicators—Test equipmentReaffirmation, and contact person.
14-225ANSI/AAMI/ISO 11137-2:2006 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseExtent of recognition and relevant guidance.
14-227ANSI/AAMI/ISO 11737-1:2006 Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on productExtent of recognition and title.
14-228ANSI/AAMI/ISO 11135-1:2007 Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devicesExtent of recognition.
14-238ANSI/AAMI/ISO 11140-5:2007, Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal testsRelevant guidance.
14-261ANSI/AAMI/ISO 17665-1:2006 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devicesExtent of recognition, relevant guidance and contact person.
14-274ANSI/AAMI/ISO 15882:2008 Sterilization of health care products—Chemical indicators—Guidance for selection, use, and interpretation of resultsExtent of recognition.
14-27614-314ANSI/AAMI ST67:2011 Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”Withdrawn and replaced with newer version.
14-285ANSI/AAMI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of resultsTitle, contact person.
14-287ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processExtent of recognition and title.
14-291ANSI/AAMI/ISO 14937:2009 Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devicesExtent of recognition.
14-295ANSI/AAMI ST81:2004/(R)2010, Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devicesRelevant guidance and contact person.
14-296ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirementsExtent of recognition, contact person and relevant guidance.
14-297ANSI/AAMI/ISO 11137-1:2006/(R)2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devicesExtent of recognition, and relevant guidance.
14-298ANSI/AAMI/ISO 11137-3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspectsExtent of recognition and relevant guidance.
14-30114-315USP 34:2011 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsWithdrawn and replaced with newer version.
14-30214-316USP 34:2011 <71> Sterility TestsWithdrawn and replaced with newer version.
14-30314-317USP 34:2011 <85> Bacterial Endotoxins TestWithdrawn and replaced with newer version.
14-30414-318USP 34:2011 <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version.
14-30514-319USP 34:2011 <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version.
14-30614-320USP 34:2011 Biological Indicator for Steam Sterilization—Self ContainedWithdrawn and replaced with newer version.
14-30714-321USP 34:2011 Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-30814-322USP 34:2011 Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-30914-323USP 34:2011 Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version.
14-31014-324USP 34:2011 <62> Microbiological Examination of Nonsterile Products: Tests for Specified MicroorganismsWithdrawn and replaced with newer version.
P. Tissue Engineering
15-715-27ASTM F2315-11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate GelsWithdrawn and replaced with newer version.
15-8ASTM F2064-00 (Reapproved 2006) 1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products ApplicationEditorial change.
15-10ASTM F2451-05 (Reapproved 2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular CartilageReaffirmation.
15-1215-28ASTM F2103-11 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product ApplicationsWithdrawn and replaced with newer version.
15-1515-29ASTM F2259-10 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) SpectroscopyWithdrawn and replaced with newer version.
15-1815-30ASTM F2212-11 Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)Withdrawn and replaced with newer version.
15-2515-31ASTM F2312-11 Standard Terminology Relating to Tissue Engineered Medical ProductsWithdrawn and replaced with newer version.
1 All standard titles in this table conform to the style requirements of the respective organizations.

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: 028.

Table 3—New Entries to the List of Recognized Standards

Recognition No.Title of standard 1Reference Number and date
A. Biocompatibility
2-173Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitizationANSI/AAMI/ISO 10993-10:2010.
2-175Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicityISO 10993-3 Second edition 2003-10-15.
2-176Biological evaluation of medical devices Part 11: Tests for systemic toxicityISO 10993-11 Second edition 2006-08-15.
2-177Biological evaluation of medical devices—Part 6: Tests for local effects after implantationISO 10993-6 Second edition 2007-04-15.
2-178Biological evaluation of medical devices—Part 12: Sample preparation and reference materialsISO 10993-12 Third edition 2007-11-15 Corrected version 2008-02-15.
2-179Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management processISO 10993-1 Fourth edition 2009-10-15.
2-181Clinical investigation of medical devices for human subjects—Good clinical practiceANSI/AAMI/ISO 14155:2011.
2-182Clinical investigation of medical devices for human subjects—Good clinical practiceISO 14155 Second edition 2011-02-01.
2-183Clinical investigation of medical devices for human subjects—Good clinical practice TECHNICAL CORRIGENDUM 1ISO 14155: 2011 Technical Corrigendum 1 Published 2011-07-15.
B. Cardiovascular
3-96Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement typeISO 81060-1 First edition 2007-12-01.
3-97Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement typeISO 81060-2 First edition 2009-05-01.
3-98Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type TECHNICAL CORRIGENDUM 1ISO 81060-2:2009 TECHNICAL CORRIGENDUM 1 Published 2011-02-15.
3-99Evaluation of particulates associated with vascular medical devicesAAMI TIR42:2010.
3-100Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipmentANSI/AAMI/IEC 60601-2-27:2011.
C. General
5-68Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validationANSI/AAMI/ISO 15223-2:2010.
5-69Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Corrigendum 1IEC 60601-1-11 (First edition—2010) April 2011.
5-70Medical devices—Application of risk management to medical devicesANSI/AAMI/ISO 14971:2007/(R)2010.
D. General Hospital/General Plastic Surgery
6-263Absorbable Surgical SutureUSP 34-NF 28 2011.
6-264Sterile, single-use intravascular catheters—Part 1: General requirementsISO 10555-1 First edition 1995-06-15 Amendment 1 1999-07-15.
6-265Sterile, single-use intravascular catheters—Part 1: General requirementsISO 10555-1 First edition 1995-06-15 AMENDMENT 2 2004-05-15.
6-268Standard Terminology Relating to Hemostatic ForcepsASTM F921—10 (Reapproved 2011).
6-269Standard Terminology for Surgical Scissors—Inserted and Non-Inserted BladesASTM F1078—10 (Reapproved 2011).
6-270Standard Terminology for Surgical Suture NeedlesASTM F1840-10 1.
6-271Standard Test Method for Bend Testing of Needles Used in Surgical SuturesASTM F1874—98 (Reapproved 2011).
6-272Standard Specification for Square Drive Interconnections on Surgical InstrumentsASTM F2062—00 (Reapproved 2011).
6-273Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood samplingISO 23908 First edition 2011-06-11.
E. In Vitro Diagnostics
7-225Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved GuidelineCLSI GP34-A.
7-226Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth EditionCLSI GP26-A4.
7-227Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved GuidelineCLSI M53-A.
F. Materials
8-211Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder formISO 5834-1 Third edition 2005-06-01.
8-212Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form TECHNICAL CORRIGENDUM 1ISO 5834-1:2005 TECHNICAL CORRIGENDUM 1 Published 2007-05-01.
8-213Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing methodsISO 5834-3 First edition 2005-07-15.
8-214Implants for surgery—Ultra-high molecular weight polyethylene—Part 4: Oxidation index measurement methodISO 5834-4 First edition 2005-05-01.
8-215Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment methodISO 5834-5 First edition 2005-06-01.
G. Neurology
17-9Implants for surgery—Active implantable medical devices Part 3: Implantable neurostimulatorsANSI/AAMI/ISO 14708-3:2008.
H. OB-GYN/Gastroenterology
9-69Water for hemodialysis and related therapiesANSI/AAMI/ISO 13959:2009.
9-70Guidance for the preparation and quality management of fluids for hemodialysis and related therapiesANSI/AAMI/ISO 23500:2011.
9-71Quality of dialysis fluid for hemodialysis and related therapiesANSI/AAMI/ISO 11663:2009.
9-72Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipmentANSI/AAMI/IEC 60601-2-16:2008.
9-73Concentrates for haemodialysis and related therapiesANSI/AAMI/ISO 13958:2009.
9-74Concentrates for haemodialysis and related therapiesISO 13958 Second edition 2009-4-15.
I. Ophthalmic
10-71Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lensesISO 14729 First edition 2001-04-15 AMENDMENT 1 2010-10-01.
10-72Ophthalmic instruments—Fundamental requirements and test methods—Part 1: General requirements applicable to all ophthalmic instrumentsISO 15004-1 First edition 200-606-01.
J. Orthopedic
11-232Implants for surgery—Components for partial and total knee joint prostheses—Part 1: Classification, definitions and designation of dimensionsISO 7207-1 Third edition 2007-02-01.
11-233Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation DevicesASTM F384—06 (Reapproved 2011).
11-234Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint ProsthesesASTM F732—00 (Reapproved 2011).
K. Radiology
12-233Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stabilityISO 11670 Second edition 2003-04-01.
12-239SAFETY OF LASER PRODUCTS—Part 1: Equipment classification and requirements, INTERPRETATION SHEET 1IEC 60825-1 (Second edition—2007) I-SH 01 December 2009.
12-240SAFETY OF LASER PRODUCTS—Part 1: Equipment classification and requirements, INTERPRETATION SHEET 2IEC 60825-1 (2007), second edition/I-SH 02 January 2011.
12-241Medical electrical equipment—Safety of radiotherapy record and verify systemsIEC 62274 First edition 2005-05.
12-242Medical electrical equipment—Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic useIEC 60601-2-57 Edition 1.0 2011-01.
12-243Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power [energy] density distributionISO 13694, First edition 2000-04-01.
12-244Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1IEC 62359 (Second edition—2010).
L. Sterility
14-325Sterilization of health care products—VocabularyISO/TS 11139 Second edition 2006-01-15.
14-326Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on productsISO 11737-1 Second edition 2006-04-01.
14-327Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization processISO 11737-2 Second edition 2009-11-15.
14-328Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11137-1 First edition 2006-04-15.
14-329Sterilization of health care products—Radiation—Part 2: Establishing the sterilization doseISO 11137-2 First edition 2006-04-15.
14-330Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspectsISO 11137-3 First edition 2006-04-15.
14-331Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devicesISO 11135-1 First edition 2007-05-01.
14-332Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal testsISO 11140-5 Second edition 2007-03-15.
14-333Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 17665-1 First edition 2006-08-15.
14-334Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of resultsISO 15882 Second edition 2008-09-01.
14-335Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residualsISO 10993-7 Second edition 2008-10-15.
14-336Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of resultsISO 14161 Second edition 2009-09-15.
14-337Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devicesISO 14937 Second edition 2009-10-15.
14-338Sterilization of health care products—Biological indicators—Part 1: General requirementsISO 11138-1 Second edition 2006-07-01.
14-339Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devicesANSI/AAMI/ISO 20857:2010.
14-340Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devicesISO 20857 First edition 2010-08-15.
14-341Standard Guide for Absorbed-Dose Mapping in Radiation Processing FacilitiesASTM E2303—11.
14-342Standard Practice for Dosimetry in Radiation ProcessingASTM E2628—09 1.
14-343Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation ProcessingASTM E2701—09.
14-344Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel DeliveryASTM F2825—10 1.
14-345Standard guide for selection and calibration of dosimetry systems for radiation processingISO/ASTM 51261 First edition 2002-03-15.
14-346Standard Practice for Use of a Polymethylmethacrylate Dosimetry SystemISO/ASTM 51276 Second edition 2002-12-15.
14-347Standard Practice for Dosimetry in Gamma Irradiation Facilities for Radiation ProcessingISO/ASTM 51702 Second edition 2004-08-15.
14-348Aseptic processing of health care products—Part 2: FiltrationANSI/AAMI/ISO 13408-2:2003.
14-349Aseptic processing of health care products—Part 3: LyophilizationANSI/AAMI/ISO 13408-3:2006.
14-350Aseptic processing of health care products—Part 4: Clean-in-place technologiesANSI/AAMI/ISO 13408-4:2005.
14-351Aseptic processing of health care products—Part 5: Sterilization in placeANSI/AAMI/ISO 13408-5:2006.
14-352Aseptic processing of health care products—Part 6: Isolator systemsANSI/AAMI/ISO 13408-6:2005.
14-353Sterilization of health care products—Chemical indicators—Part 1: General requirementsISO 11140-1 Second edition 2005-07-15.
14-354Sterilization of health care products—Biological and chemical indicators—Test equipmentISO 18472 First edition 2006-06-01.
14-355Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-1 First edition 2006-04-15.
14-356Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processesISO 11607-2 First edition 2006-04-15.
14-357Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on productsISO 11737-1:2006 TECHNICAL CORRIGENDUM 1 Published 2007-05-15.
M. Tissue Engineering
15-32Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (1 H NMR) SpectroscopyASTM F2260-03 (Reapproved 2008).
15-33Standard Test Method for Determining the Molar Mass of Chitosan and Chitosan Salts by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)ASTM F2602-08 1.
15-34Standard Test Method for Determining the Molar Mass of Sodium Alginate by Size Exclusion Chromatography with Multi-angle Light Scattering Detection (SEC-MALS)ASTM F2605-08 1.
15-35Standard Guide for Characterization of Hydrogels used in Regenerative MedicineASTM F2900-11.
15-36Standard Guide for Assessment of Adventitious Agents in Tissue Engineered Medical Products (TEMPs)ASTM F2383-11.
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 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: 028'' 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. Identify comments 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: 028. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.

Dated: March 12, 2012.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2012-6389 Filed 3-15-12; 8:45 am]

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