Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 028
Federal RegisterMar 16, 2012
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-N-0451]
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 028
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: 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
1
Change
A. Anesthesia
1-15
ISO 5361-4 Second edition 1987-12-15 Tracheal tubes—Part 4: Cole type
Contact person.
1-18
ISO 8359 Second edition 1996-12-15 Oxygen concentrators for medical use—Safety requirements
Contact person.
1-35
ISO 5361 First edition 1999-09-15 Corrected and reprinted 1999-12-15 Anaesthetic and respiratory equipment—Tracheal tubes and connectors
Contact person.
1-36
ISO 5366-3 Second edition 2001-08-15 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Pediatric tracheostomy tubes
Contact person.
1-44
ISO 5366-1 Fourth edition 2000-12-15 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adults
Contact person.
1-46
ISO 5367 Fourth edition 2000-06-01 Breathing tubes intended for use with anaesthetic apparatus and ventilators
Contact person.
1-56
CGA V-7.1:1997 (Reaffirmed 2008) Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
Contact person.
1-57
ASTM F1101-90 (Reapproved 2003)
1
Standard Specification for Ventilators Intended for Use During Anesthesia
Contact person.
1-58
ASTM G175-03 (Reapproved 2011) Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
Reaffirmation.
1-60
IEC 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 ventilators
Contact person.
1-62
ISO 5356-1 Third edition 2004-05-15 Anaesthetic and respiratory equipment—Conical connectors: Part 1: Cones and sockets
Contact person.
1-69
ASTM F 1464-93 (Reapproved 2005) Standard Specification for Oxygen Concentrators for Domiciliary Use
Contact person.
1-70
ASTM F 1246-91 (Reapproved 2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1—Positive-Pressure Ventilators and Ventilator Circuits
Contact person.
1-72
ISO 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 resuscitators
Contact person.
1-73
ISO 10651-4 First edition 2002-03-01 Lung ventilators—Part 4: Particular requirements for operator-powered resuscitators
Contact person.
1-75
ISO 5362 Fourth edition 2006-06-01 Anaesthetic reservoir bags
Contact person.
1-79
ISO 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 performance
Contact person.
B. Biocompatibility
2-87
2-174
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
Withdrawn and replaced with newer version.
2-93
ASTM F763-04 (Reapproved 2010) Standard Practice for Short-Term Screening of Implant Materials
Reaffirmation.
2-94
ASTM F981-04 (Reapproved 2010) Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Reaffirmation.
2-108
ASTM F1905-98 Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
Withdrawn.
2-114
ASTM F1877-05 (Reapproved 2010) Standard Practice for Characterization of Particles
Reaffirmation.
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 and Contact person.
2-118
ANSI/AAMI/ISO 10993-11:2006/(R)2010 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity
Reaffirmation.
2-120
ANSI/AAMI/ISO 10993-6:2007/(R)2010 Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
Reaffirmation.
2-126
ASTM F748-06 (Reapproved 2010) Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Reaffirmation.
2-134
ASTM F2065-00 (Reapproved 2010) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials
Reaffirmation.
2-155
ASTM F2147-01 (Reapproved 2010) Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
Reaffirmation.
2-157
2-184
USP34-NF29:2011<87> Biological Reactivity Tests, In Vitro—Direct Contact Test
Withdrawn and replaced with newer version.
2-158
2-185
USP 34-NF29:2011 Biological Tests <87> Biological Reactivity Test, In Vitro—Elution Test
Withdrawn and replaced with newer version.
2-159
2-186
USP 34-NF29:2011 Biological Tests <88> Biological Reactivity Tests, In Vivo, Procedure Preparation of Sample
Withdrawn and replaced with newer version.
2-160
2-187
USP 34-NF29:2011 Biological Tests <88> Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test
Withdrawn and replaced with newer version.
2-161
2-188
USP 34-NF29:2011 Biological Tests <88> Biological Reactivity Tests, In Vivo Classification of Plastics—Systemic Injection Test
Withdrawn and replaced with newer version.
2-165
ANSI/AAMI/ISO 10993-14:2001 (Reapproved 2006) Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics
Reaffirmation.
2-166
2-180
ANSI/AAMI/ISO 10993-16:2010 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables
Withdrawn and replaced with newer version.
C. Cardiovascular
3-52
ANSI/AAMI EC12:2000/(R)2010 Disposable ECG electrodes
Reaffirmation.
3-61
3-95
IEC 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 equipment
Newer version with transition period.
D. Dental/ENT
4-76
ISO 7785-2 Second edition 1995-08-01 Dental handpieces—Part 2: Straight and geared angle handpieces
Contact person.
4-83
ISO 11498 First edition 1997-02-15 Dental handpieces—Dental low-voltage electrical motors
Contact person.
4-84
ISO 13294 First edition 1997-05-01 Dental handpieces—Dental air-motors
Contact person.
4-90
ANSI S3.39 Reaffirmed by ANSI May 18, 2007 Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
Contact person.
4-119
ANSI/ADA Specification No. 82-1998 (R2009) Reversible/Irreversible Hydrocolloid Impression Material Systems
Reaffirmation.
4-121
ISO 7494-2 First edition 2003-03-01 Dentistry—Dental units—Part 2: Water and air supply
Contact person.
4-123
ANSI/ASA S3.6-2004 Specification for Audiometers
Contact person.
4-126
ISO 10477 Second edition 2004-10-01 Dentistry—Polymer-based crown and bridge materials
Contact person.
4-134
ISO 7494-1 First edition 2004-08-15 Dentistry—Dental units—Part 1: General requirements and test methods
Contact person.
4-136
ASTM Designation: F2504-05 Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
Contact person.
4-150
ANSI/ADA Specification No. 19-2003 Dental Elastometric Impression Material:2003
Contact person.
4-154
ISO 4823 Third edition 2000-12-15 Dentistry—Elastometric impression materials
Contact person.
4-155
ISO 4823:2000 Technical Corrigendum 1 Published 2004-07-15 Dentistry—Elastomeric impression materials
Contact person.
4-156
ISO 4823 Third edition 2000-12-15 Amendment 1 2007-07-01 Dentistry—Elastometric impression materials
Contact person.
4-160
ANSI S3.1-1999 (Reaffirmed by ANSI October 28, 2008) American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
Contact person.
4-162
ANSI S3.4-2007 American National Standard Procedure for the Computation of Loudness of Steady Sounds
Contact person.
4-163
ANSI S3.5-1997 (R1986) Reaffirmed by ANSI May 18, 2007 American National Standard Methods for Calculation of the Speech Intelligibility Index
Contact person.
4-164
ANSI S3.7-1995 (Reaffirmed by ANSI October 28, 2008) American National Standard Method for Coupler Calibration of Earphones
Contact person.
4-165
ANSI S3.13-1987 Reaffirmed by ANSI June 1, 2007 American National Standard Mechanical Coupler for Measurement of Bone Vibrators
Contact person.
4-170
ANSI S3.36-1985 Reaffirmed by ANSI on 4/27/2006 American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
Contact person.
4-171
ANSI S3.37-1987 (Reaffirmed by ANSI May 18, 2007) American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
Contact person.
4-172
ANSI S3.42-1992 Reaffirmed by ANSI May 18, 2007 American National Standard Testing Hearing Aids with a Broad-Band Noise Signal
Contact person.
4-173
ANSI S3.44-1996 Reaffirmed by ANSI on 27 April 2006 American National Standard Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
Contact person.
4-175
ANSI S3.46-1997 American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
Contact person.
4-177
ANSI S12.65-2006 (Reaffirmed by ANSI March 30, 2011) American National Standard For Rating Noise with Respect to Speech Interference
Reaffirmation.
4-179
ISO 7405 Second edition 2008-12-15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistry
Contact person.
4-180
ISO 9168 Third edition 2009-07-15 Dentistry—Hose connectors for air driven dental handpieces
Contact person.
4-183
ANSI S3.2-2009 American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
Contact person.
4-184
ANSI/ASA S3.25-2009 American National Standard For an Occluded Ear Simulator
Contact person.
4-185
ANSI/ASA S3.45-2009 American National Standard Procedures for Testing Basic Vestibular Function
Contact person.
4-186
ANSI/ASA S12.2-2008 American National Standard Criteria for Evaluating Room Noise
Contact person.
4-190
ANSI/ASA S3.35-2010 American National Standard Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
Contact person.
4-192
ANSI/ADA Specification No. 58-2010 Root Canal Files Type H (Hedstrom): 2007
Contact person.
E. General
5-29
AAMI/ANSI HE74-2001 (R 2009) Human factors design process for medical devices
Withdrawn, see 5-67.
5-39
IEC 60812 Second edition 2006-01 Analysis techniques for system reliability—Procedure for failure mode and effects analysis (FMEA)
Contact person.
5-40
ISO 14971 Second edition 2007-03-01 Medical devices—Application of risk management to medical devices
Contact person.
5-42
ASTM D903-98 (Reapproved 2010) Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
Reaffirmation.
5-58
IEC 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 environment
Extent of recognition and relevant guidance.
F. General Hospital/General Plastic Surgery
6-117
ASTM F2172-02(2011) Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
Reaffirmation and Contact person.
6-161
ISO 10555-1 First edition 1995-06-15 Sterile, Single-use intravascular catheters—Part 1: General requirements
Title and Contact person.
6-164
ISO 10555-5 First edition 1996-06-15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters
Title and Contact person.
6-164
6-266
ISO 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 catheters
See 6-164.
6-164
6-267
ISO 10555-5:1996 TECHNICAL CORRIGENDUM 1 Published 2002-06-15 Sterile, single-use intravascular catheters—Part 5: Over-needle peripheral catheters TECHNICAL CORRIGENDUM
See 6-164.
6-176
ASTM D7103-06
1
Standard Guide for Assessment of Medical Gloves
Editorial change.
6-177
ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Reaffirmation.
6-198
6-254
ASTM F2100-11, Standard Specification for Performance of Materials Used in Medical Face Masks
Withdrawn and replaced with newer version.
6-203
ASTM D6499-07, Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products
Extent of recognition.
6-219
6-255
USP 34-NF 29<11>:2011 Sodium Chloride Irrigation
Withdrawn and replaced with newer version.
6-226
6-256
USP 34-NF 29<11>:2011 Sodium Chloride Injection
Withdrawn and replaced with newer version.
6-246
6-257
USP 34-NF 29 2011 Nonabsorbable Surgical Suture
Withdrawn and replaced with newer version.
6-248
6-258
USP 34-NF 29 2011 <881> Tensile Strength
Withdrawn and replaced with newer version.
6-249
6-259
USP 34-NF 29 2011 <861> Sutures Diameter
Withdrawn and replaced with newer version.
6-250
6-260
USP 34-NF 29 2011 <871> Sutures—Needle
Withdrawn and replaced with newer version.
6-251
6-261
USP 34-NF 29 <11>:2011 Sterile Water for Irrigation
Withdrawn and replaced with newer version.
6-252
6-262
USP 34-NF 29 <11>:2011 Heparin Lock Flush Solution
Withdrawn and replaced with newer version.
G. In Vitro Diagnostics
7-102
7-221
CLSI H01-A6 Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard—Sixth Edition
Withdrawn and replaced with newer version.
7-112
CLSI H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
Withdrawn duplicate, see 7-162.
7-126
7-222
CLSI M24-A2 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standards—Second Edition
Withdrawn and replaced with newer version Contact person.
7-128
CLSI EP14-A2 Evaluation of Matrix Effects; Approved Guideline—Second Edition
Withdrawn duplicate, see 7-143.
7-130
CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition
Withdrawn duplicate, see 7-165.
7-134
CLSI GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition
Withdrawn duplicate, see 7-166.
7-140
7-223
GP22-A3—Quality Management System: Continual Improvement; Approved Guideline—Third Edition
Withdrawn and replaced with newer version.
7-143
CLSI EP14-A2 Evaluation of Matrix Effects; Approved Guideline—Second Edition
Contact person, Type of standard, Processes impacted.
7-147
CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition
Withdrawn duplicate, see 7-178.
7-150
CLSI H43-A2 Clinical Flow Cytometric Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline—Second Edition
Title, Contact person.
7-162
CLSI H49-A Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
Contact person, Devices affected, Processes affected, Type of standard, CFR citation and product codes.
7-165
CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition
Contact person, Devices affected, Processes affected, Type of standard, CFR citation and product codes.
7-166
CLSI GP20-A2 Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline—Second Edition
Devices affected, Process affected, CFR citation and product codes.
7-169
CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition
Withdrawn duplicate, see 7-204.
7-172
CLSI C28-A3 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition
Withdrawn duplicate, see 7-224.
7-202
7-224
CLSI C28-A3c Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline—Third Edition
Withdrawn and replaced with newer version.
7-178
CLSI M22-A3 Quality Control for Commercially Prepared Microbiological Culture Media; Approved Standard—Third Edition
Extent of recognition, CFR citation and product codes.
7-204
CLSI M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts; Approved Standard—Third Edition
Contact person.
7-206
CLSI 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 Edition
Title, Contact person.
H. Materials
11-219
8-203
ASTM F2026-08 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Transferred.
8-101
8-204
ASTM F2118-10 Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
Withdrawn and replaced with newer version.
8-105
8-205
ASTM F1635-11 Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Withdrawn and replaced with newer version.
8-114
ASTM F2255-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Lap-Shear by Tension Loading
Reaffirmation.
8-115
ASTM F2256-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
Reaffirmation.
8-116
ASTM F2258-05 (Reapproved 2010) Standard Test Method for Strength Properties of Tissue Adhesives in Tension
Reaffirmation.
8-119
8-206
ASTM 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.
8-121
ASTM F2005-05 (Reapproved 2010) Standard Terminology for Nickel-Titanium Shape Memory Alloys
Reaffirmation.
8-125
ASTM F2004-05 (Reapproved 2010) Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
Reaffirmation.
8-126
ASTM F561-05a (Reapproved 2010) Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
Reaffirmation.
8-132
ASTM F1088-04a (Reapproved 2010) Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Reaffirmation and contact person.
8-135
ASTM F2392-04 (Reapproved 2010) Standard Test Method for Burst Strength of Surgical Sealants
Reaffirmation.
8-136
ASTM F2458-05 (Reapproved 2010) Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
Reaffirmation.
8-172
8-207
ASTM F1926/F1926M-10 Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
Withdrawn and replaced with newer version.
8-178
8-208
ASTM F648-10a Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Withdrawn and replaced with newer version.
8-181
8-209
ASTM F899-11 Standard Specification for Wrought Stainless Steels for Surgical Instruments
Withdrawn and replaced with newer version.
8-191
8-210
ASTM F2182-11 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Withdrawn and replaced with newer version.
8-195
ASTM F2024-10, Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
Extent of Recognition, devices affected, CFR citations and associated procodes and contact person.
I. Neurology
17-1
ANSI/AAMI NS28:1988/(R) 2010 Intracranial pressure monitoring devices
Reaffirmation.
17-3
ISO 7197:2006 Third edition 2006-06-01 Neurosurgical implants—Sterile, single-use hydrocephalus shunts and components
Contact person.
17-4
ASTM F 647-94 (Reapproved 2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
Contact person.
17-7
ISO 7197:2006 Technical Corrigendum 1 Published:2007-07-01 Neurological implants—Sterile, single-use hydrocephalus shunts and components
Contact person.
J. OB-GYN/Gastroenterology
9-21
ISO 8600-4 First edition 1997-07-01 Optics and optical instruments—Medical endoscopes and certain accessories—Part 4: Determination of maximum width of insertion portion
Contact person.
9-37
ISO 8600-1 Second edition 2005-05-01 Optics and photonics—Medical endoscopes and endotherapy devices—Part 1: General requirements
Contact person.
9-38
ISO 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 optics
Contact person.
9-39
ISO 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 optics
Contact person.
9-40
ISO 8600-6 First edition 2005-03-15 Optics and photonics—Medical endoscopes and endotherapy devices—Part 6: Vocabulary
Contact person.
9-44
ASTM Designation: F 623-99 (Reapproved 2006) Standard Performance Specification for Foley Catheter
Contact person.
9-49
AAMI/ANSI RD61:2006, Concentrates for hemodialysis
Withdrawn, see 9-73.
9-50
ANSI/AAMI RD52:2004/(R)2010 Dialysate for Hemodialysis
Withdrawn, see 9-70 and 9-71.
9-53
ASTM F 1992-99 (Reapproved 2007) Standard Practice for Reprocessing of Reusable, Heat-Stable Endoscopic Accessory Instruments (EAI) Used with Flexible Endoscopes
Contact person.
9-55
AAMI/ANSI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009, Water treatment equipment for hemodialysis applications
Withdrawn, see 9-69.
9-61
IEC 60601-2-18 Edition 3.0 2009-08 Medical electrical equipment—Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Contact person.
9-59
AAMI/ANSI RD5:2003/(R)2008, Hemodialysis
Withdrawn, see 9-72.
K. Ophthalmic
10-15
ISO 9394 Second edition 1998-08-15 Ophthalmic optics—Contact lenses and contact lens care products—Determination of biocompatibility by ocular study using rabbit eyes
Contact person.
10-24
10-67
ISO 11986 Second edition 2010-11-01 Ophthalmic optics—Contact lenses and contact lens care products—Determination of preservative uptake and release
Withdrawn and replaced with newer version.
10-26
10-68
ISO 13212 Second edition 2011-05-15 Ophthalmic optics—Contact lens care products—Guidelines for determination of shelf-life
Withdrawn and replaced with newer version.
10-28
ISO 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 lenses
Contact person.
10-29
ISO 14730 First edition 2000-09-15 Ophthalmic optics—Contact lens care products—Antimicrobial preservative efficacy testing and guidance on determining discard date
Contact person.
10-33
10-69
ANSI Z80.18-2010 for Ophthalmics—Contact Lens Care Products—Vocabulary, Performance Specifications, and Test Methodology
Withdrawn and replaced with newer version.
10-38
10-70
ISO 10943 Third edition 2011-08-15 Ophthalmic instruments—Indirect ophthalmoscopes
Withdrawn and replaced with newer version.
10-59
ISO 11980 Second edition 2009-10-15 Ophthalmic optics—Contact lenses and contact lens care products—Guidance for clinical investigations
Contact person.
L. Orthopedic
11-167
11-226
ASTM F1089-10 Standard Test Method for Corrosion of Surgical Instruments
Withdrawn and replaced with newer version.
11-180
11-227
ASTM F366-10 Standard Specification for Fixation Pins and Wires
Withdrawn and replaced with newer version; change contact.
11-196
ASTM F1672-95 (Reapproved 2011) Standard Specification for Resurfacing Patellar Prosthesis
Reaffirmation.
11-201
11-228
ASTM F564-10 Standard Specification and Test Methods for Metallic Bone Staples
Withdrawn and replaced with newer version.
11-217
11-229
ASTM F2083-10 Standard Specification for Total Knee Prosthesis
Withdrawn and replaced with newer version.
11-221
11-230
ASTM F1717-10 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Withdrawn and replaced with newer version.
11-155
11-231
ISO 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 materials
Withdrawn and replaced with newer version.
11-219
8-203
ASTM F2026-10 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Transferred and replaced with a newer version.
M. Radiology
12-52
UL 544 (1998), Standard for Medical and Dental Equipment—Ed. 4.0
Withdrawn, see 5-4 and 5-52.
12-62
UL 187 (1998), Standard for X-ray Equipment—Ed. 7.0
Withdrawn, see 5-4 and 5-52.
12-100
NEMA UD 3-2004 (R2009), Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, Revision 2
Reaffirmation.
12-105
NEMA UD 2-2004 (R2009), Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3
Reaffirmation.
12-106
ISO 17526 First edition 2003-06-15, Optics and optical instruments—Lasers and laser-related equipment—Lifetime of lasers
Contact person.
12-108
12-246
ISO 21254-2 First edition 2011-07-15 Lasers and laser-related equipment—Test methods for laser-induced damage threshold—Part 2: Threshold determination
Withdrawn and replaced with newer version.
12-109
12-245
ISO 21254-1 First edition 2011-07-15 Lasers and laser-related equipment—Test methods for laser-induced damage threshold—Part 1: Definitions and general principles
Withdrawn and replaced with newer version.
12-110
ISO 11551 Second edition 2003-12-01, Optics and optical instruments—Lasers and laser-related equipment—Test method for absorptance of optical laser components
Contact person.
12-113
ISO 12005 Second edition 2003-04-01, Lasers and laser-related equipment—Test methods for laser beam parameters—Polarization
Contact person.
12-115
ISO 13695 First edition 2004-06-01, Optics and photonics—Lasers and laser-related equipment—Test methods for the spectral characteristics of lasers
Contact person.
12-117
ISO 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 aspects
Contact person.
12-134
ISO 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 beams
Contact person.
12-140
AIUM RTD2-2004, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 2
Title.
12-142
ISO 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 beams
Contact person.
12-143
ISO 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 sensors
Contact person.
12-144
12-247
ISO 11990-1 First edition 2011-08-01 Lasers and laser-related equipment—Determination of laser resistance of tracheal tubes—Part 1: Tracheal tube shaft
Withdrawn and replaced with newer version.
12-154
12-248
ISO 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 capabilities
Withdrawn and replaced with newer version.
12-155
ISO 11554 Third edition 2006-05-01, Optics and photonics—Lasers and laser-related equipment—Test methods for laser beam power, energy and temporal characteristics
Contact person.
12-156
ISO 11670:2003 Technical Corrigendum 1 Published 2004-05-15, Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability
Contact person.
12-157
ISO 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 distribution
Contact person.
12-174
ISO 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 components
Contact person.
12-175
ISO 24013 First edition 2006-11-15, Optics and photonics—Lasers and laser-related equipment—Measurement of phase retardation of optical components for polarized laser radiation
Contact person.
12-177
12-249
ANSI/UL 122-2007 Standard for Photographic Equipment—Ed. 5.0
Withdrawn and replaced with newer version.
12-125
12-231
NEMA MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
Withdrawn and replaced with newer version.
12-151
12-232
NEMA MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
Withdrawn and replaced with newer version.
12-160
12-234
NEMA MS 12-2010, Quantification and Mapping of Geometric Distortion for Special Applications
Withdrawn and replaced with newer version.
12-162
12-235
IEC 60731 Edition 3.0 2011-02, Amendment 1, Medical electrical equipment—Dosimeters with ionization chambers as used in radiotherapy
Withdrawn and replaced with newer version.
12-178
12-236
IEC 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 devices
Newer version with transition period.
12-191
12-237
IEC 62359 Edition 2.0 2010-10, Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields
Withdrawn and replaced with newer version.
12-218
12-238
NEMA PS 3.1-3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set
Withdrawn and replaced with newer version.
N. Software/Informatics
13-11
13-30
CLSI AUTO3-A2 Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard, Second Edition 2009
Withdrawn and replaced with newer version.
O. Sterility
14-135
AAMI/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 heat
Withdrawn, see 14-339.
14-169
ASTM F2391-05 (Reapproved 2011) Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
Reaffirmation.
14-170
14-313
ASTM F2475-11 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Withdrawn and replaced with newer version.
14-181
ANSI/AAMI ST58:2005/(R)2010 Chemical sterilization and high-level disinfection in health care facilities
Reaffirmation and contact person.
14-193
ANSI/AAMI/ISO 11607-1:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems, and packaging systems
Reaffirmation.
14-194
ANSI/AAMI/ISO 11607-2:2006/(R)2010 Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing, and assembly processes
Reaffirmation.
14-195
ANSI/AAMI/ISO 11140-1:2005(R)2010 Sterilization of health care products—Chemical indicators—Part 1: General requirements
Reaffirmation, extent of recognition, and type of standard.
14-201
ANSI/AAMI ST77:2006/(R)2010 Containment devices for reusable medical device sterilization
Reaffirmation and contact person.
14-214
AOAC 6.2.04:2009 Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use—Dilution Method
Reaffirmation.
14-216
AOAC 6.2.06:2009 Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use—Dilution Method
Reaffirmation.
14-219
AOAC 6.3.06:2008 Official Method 965.12, Tuberculocidal Activity of Disinfectants
Reaffirmation.
14-222
ANSI/AAMI/ISO 18472:2006/(R)2010 Sterilization of health care products—Biological and chemical indicators—Test equipment
Reaffirmation, and contact person.
14-225
ANSI/AAMI/ISO 11137-2:2006 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
Extent of recognition and relevant guidance.
14-227
ANSI/AAMI/ISO 11737-1:2006 Sterilization of health care products—Microbiological methods—Part 1: Determination of the population of microorganisms on product
Extent of recognition and title.
14-228
ANSI/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 devices
Extent of recognition.
14-238
ANSI/AAMI/ISO 11140-5:2007, Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
Relevant guidance.
14-261
ANSI/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 devices
Extent of recognition, relevant guidance and contact person.
14-274
ANSI/AAMI/ISO 15882:2008 Sterilization of health care products—Chemical indicators—Guidance for selection, use, and interpretation of results
Extent of recognition.
14-276
14-314
ANSI/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.
14-285
ANSI/AAMI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results
Title, contact person.
14-287
ANSI/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 process
Extent of recognition and title.
14-291
ANSI/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 devices
Extent of recognition.
14-295
ANSI/AAMI ST81:2004/(R)2010, Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices
Relevant guidance and contact person.
14-296
ANSI/AAMI/ISO 11138-1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirements
Extent of recognition, contact person and relevant guidance.
14-297
ANSI/AAMI/ISO 11137-1:2006/(R)2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
Extent of recognition, and relevant guidance.
14-298
ANSI/AAMI/ISO 11137-3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects
Extent of recognition and relevant guidance.
14-301
14-315
USP 34:2011 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
Withdrawn and replaced with newer version.
14-302
14-316
USP 34:2011 <71> Sterility Tests
Withdrawn and replaced with newer version.
14-303
14-317
USP 34:2011 <85> Bacterial Endotoxins Test
Withdrawn and replaced with newer version.
14-304
14-318
USP 34:2011 <151> Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer version.
14-305
14-319
USP 34:2011 <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer version.
14-306
14-320
USP 34:2011 Biological Indicator for Steam Sterilization—Self Contained
Withdrawn and replaced with newer version.
14-307
14-321
USP 34:2011 Biological Indicator for Dry-Heat Sterilization, Paper Carrier
Withdrawn and replaced with newer version.
14-308
14-322
USP 34:2011 Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
Withdrawn and replaced with newer version.
14-309
14-323
USP 34:2011 Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer version.
14-310
14-324
USP 34:2011 <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
Withdrawn and replaced with newer version.
P. Tissue Engineering
15-7
15-27
ASTM F2315-11 Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
Withdrawn and replaced with newer version.
15-8
ASTM 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 Application
Editorial change.
15-10
ASTM F2451-05 (Reapproved 2010) Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
Reaffirmation.
15-12
15-28
ASTM F2103-11 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
Withdrawn and replaced with newer version.
15-15
15-29
ASTM F2259-10 Standard Test Method for Determining the Chemical Composition and Sequence in Alginate by Proton Nuclear Magnetic Resonance (1H NMR) Spectroscopy
Withdrawn and replaced with newer version.
15-18
15-30
ASTM 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.
15-25
15-31
ASTM F2312-11 Standard Terminology Relating to Tissue Engineered Medical Products
Withdrawn 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
1
Reference
Number and date
A. Biocompatibility
2-173
Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization
ANSI/AAMI/ISO 10993-10:2010.
2-175
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-3 Second edition 2003-10-15.
2-176
Biological evaluation of medical devices Part 11: Tests for systemic toxicity
ISO 10993-11 Second edition 2006-08-15.
2-177
Biological evaluation of medical devices—Part 6: Tests for local effects after implantation
ISO 10993-6 Second edition 2007-04-15.
2-178
Biological evaluation of medical devices—Part 12: Sample preparation and reference materials
ISO 10993-12 Third edition 2007-11-15 Corrected version 2008-02-15.
2-179
Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process
ISO 10993-1 Fourth edition 2009-10-15.
2-181
Clinical investigation of medical devices for human subjects—Good clinical practice
ANSI/AAMI/ISO 14155:2011.
2-182
Clinical investigation of medical devices for human subjects—Good clinical practice
ISO 14155 Second edition 2011-02-01.
2-183
Clinical investigation of medical devices for human subjects—Good clinical practice TECHNICAL CORRIGENDUM 1
ISO 14155: 2011 Technical Corrigendum 1 Published 2011-07-15.
B. Cardiovascular
3-96
Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type
ISO 81060-1 First edition 2007-12-01.
3-97
Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type
ISO 81060-2 First edition 2009-05-01.
3-98
Non-invasive sphygmomanometers—Part 2: Clinical validation of automated measurement type TECHNICAL CORRIGENDUM 1
ISO 81060-2:2009 TECHNICAL CORRIGENDUM 1 Published 2011-02-15.
3-99
Evaluation of particulates associated with vascular medical devices
AAMI TIR42:2010.
3-100
Medical electrical equipment—Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
ANSI/AAMI/IEC 60601-2-27:2011.
C. General
5-68
Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validation
ANSI/AAMI/ISO 15223-2:2010.
5-69
Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment Corrigendum 1
IEC 60601-1-11 (First edition—2010) April 2011.
5-70
Medical devices—Application of risk management to medical devices
ANSI/AAMI/ISO 14971:2007/(R)2010.
D. General Hospital/General Plastic Surgery
6-263
Absorbable Surgical Suture
USP 34-NF 28 2011.
6-264
Sterile, single-use intravascular catheters—Part 1: General requirements
ISO 10555-1 First edition 1995-06-15 Amendment 1 1999-07-15.
6-265
Sterile, single-use intravascular catheters—Part 1: General requirements
ISO 10555-1 First edition 1995-06-15 AMENDMENT 2 2004-05-15.
6-268
Standard Terminology Relating to Hemostatic Forceps
ASTM F921—10 (Reapproved 2011).
6-269
Standard Terminology for Surgical Scissors—Inserted and Non-Inserted Blades
ASTM F1078—10 (Reapproved 2011).
6-270
Standard Terminology for Surgical Suture Needles
ASTM F1840-10
1
.
6-271
Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
ASTM F1874—98 (Reapproved 2011).
6-272
Standard Specification for Square Drive Interconnections on Surgical Instruments
ASTM F2062—00 (Reapproved 2011).
6-273
Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 23908 First edition 2011-06-11.
E. In Vitro Diagnostics
7-225
Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline
CLSI GP34-A.
7-226
Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition
CLSI GP26-A4.
7-227
Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
CLSI M53-A.
F. Materials
8-211
Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form
ISO 5834-1 Third edition 2005-06-01.
8-212
Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 1: Powder form TECHNICAL CORRIGENDUM 1
ISO 5834-1:2005 TECHNICAL CORRIGENDUM 1 Published 2007-05-01.
8-213
Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 3: Accelerated ageing methods
ISO 5834-3 First edition 2005-07-15.
8-214
Implants for surgery—Ultra-high molecular weight polyethylene—Part 4: Oxidation index measurement method
ISO 5834-4 First edition 2005-05-01.
8-215
Implants for surgery—Ultra-high-molecular-weight polyethylene—Part 5: Morphology assessment method
ISO 5834-5 First edition 2005-06-01.
G. Neurology
17-9
Implants for surgery—Active implantable medical devices Part 3: Implantable neurostimulators
ANSI/AAMI/ISO 14708-3:2008.
H. OB-GYN/Gastroenterology
9-69
Water for hemodialysis and related therapies
ANSI/AAMI/ISO 13959:2009.
9-70
Guidance for the preparation and quality management of fluids for hemodialysis and related therapies
ANSI/AAMI/ISO 23500:2011.
9-71
Quality of dialysis fluid for hemodialysis and related therapies
ANSI/AAMI/ISO 11663:2009.
9-72
Medical electrical equipment, Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment
ANSI/AAMI/IEC 60601-2-16:2008.
9-73
Concentrates for haemodialysis and related therapies
ANSI/AAMI/ISO 13958:2009.
9-74
Concentrates for haemodialysis and related therapies
ISO 13958 Second edition 2009-4-15.
I. Ophthalmic
10-71
Ophthalmic optics—Contact lens care products—Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14729 First edition 2001-04-15 AMENDMENT 1 2010-10-01.
10-72
Ophthalmic instruments—Fundamental requirements and test methods—Part 1: General requirements applicable to all ophthalmic instruments
ISO 15004-1 First edition 200-606-01.
J. Orthopedic
11-232
Implants for surgery—Components for partial and total knee joint prostheses—Part 1: Classification, definitions and designation of dimensions
ISO 7207-1 Third edition 2007-02-01.
11-233
Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
ASTM F384—06 (Reapproved 2011).
11-234
Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
ASTM F732—00 (Reapproved 2011).
K. Radiology
12-233
Lasers and laser-related equipment—Test methods for laser beam parameters—Beam positional stability
ISO 11670 Second edition 2003-04-01.
12-239
SAFETY OF LASER PRODUCTS—Part 1: Equipment classification and requirements, INTERPRETATION SHEET 1
IEC 60825-1 (Second edition—2007) I-SH 01 December 2009.
12-240
SAFETY OF LASER PRODUCTS—Part 1: Equipment classification and requirements, INTERPRETATION SHEET 2
IEC 60825-1 (2007), second edition/I-SH 02 January 2011.
12-241
Medical electrical equipment—Safety of radiotherapy record and verify systems
IEC 62274 First edition 2005-05.
12-242
Medical 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 use
IEC 60601-2-57 Edition 1.0 2011-01.
12-243
Optics and optical instruments—Lasers and laser-related equipment—Test methods for laser beam power [energy] density distribution
ISO 13694, First edition 2000-04-01.
12-244
Ultrasonics—Field characterization—Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields CORRIGENDUM 1
IEC 62359 (Second edition—2010).
L. Sterility
14-325
Sterilization of health care products—Vocabulary
ISO/TS 11139 Second edition 2006-01-15.
14-326
Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products
ISO 11737-1 Second edition 2006-04-01.
14-327
Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 11737-2 Second edition 2009-11-15.
14-328
Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-1 First edition 2006-04-15.
14-329
Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose
ISO 11137-2 First edition 2006-04-15.
14-330
Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects
ISO 11137-3 First edition 2006-04-15.
14-331
Sterilization of health care products—Ethylene oxide—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11135-1 First edition 2007-05-01.
14-332
Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
ISO 11140-5 Second edition 2007-03-15.
14-333
Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 17665-1 First edition 2006-08-15.
14-334
Sterilization of health care products—Chemical indicators—Guidance for selection, use and interpretation of results
ISO 15882 Second edition 2008-09-01.
14-335
Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
ISO 10993-7 Second edition 2008-10-15.
14-336
Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results
ISO 14161 Second edition 2009-09-15.
14-337
Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14937 Second edition 2009-10-15.
14-338
Sterilization of health care products—Biological indicators—Part 1: General requirements
ISO 11138-1 Second edition 2006-07-01.
14-339
Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 20857:2010.
14-340
Sterilization of health care products—Dry heat—Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 20857 First edition 2010-08-15.
14-341
Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities
ASTM E2303—11.
14-342
Standard Practice for Dosimetry in Radiation Processing
ASTM E2628—09
1
.
14-343
Standard Guide for Performance Characterization of Dosimeters and Dosimetry Systems for Use in Radiation Processing
ASTM E2701—09.
14-344
Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery
ASTM F2825—10
1
.
14-345
Standard guide for selection and calibration of dosimetry systems for radiation processing
ISO/ASTM 51261 First edition 2002-03-15.
14-346
Standard Practice for Use of a Polymethylmethacrylate Dosimetry System
ISO/ASTM 51276 Second edition 2002-12-15.
14-347
Standard Practice for Dosimetry in Gamma Irradiation Facilities for Radiation Processing
ISO/ASTM 51702 Second edition 2004-08-15.
14-348
Aseptic processing of health care products—Part 2: Filtration
ANSI/AAMI/ISO 13408-2:2003.
14-349
Aseptic processing of health care products—Part 3: Lyophilization
ANSI/AAMI/ISO 13408-3:2006.
14-350
Aseptic processing of health care products—Part 4: Clean-in-place technologies
ANSI/AAMI/ISO 13408-4:2005.
14-351
Aseptic processing of health care products—Part 5: Sterilization in place
ANSI/AAMI/ISO 13408-5:2006.
14-352
Aseptic processing of health care products—Part 6: Isolator systems
ANSI/AAMI/ISO 13408-6:2005.
14-353
Sterilization of health care products—Chemical indicators—Part 1: General requirements
ISO 11140-1 Second edition 2005-07-15.
14-354
Sterilization of health care products—Biological and chemical indicators—Test equipment
ISO 18472 First edition 2006-06-01.
14-355
Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-1 First edition 2006-04-15.
14-356
Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11607-2 First edition 2006-04-15.
14-357
Sterilization of medical devices—Microbiological methods—Part 1: Determination of a population of microorganisms on products
ISO 11737-1:2006 TECHNICAL CORRIGENDUM 1 Published 2007-05-15.
M. Tissue Engineering
15-32
Standard Test Method for Determining Degree of Deacetylation in Chitosan Salts by Proton Nuclear Magnetic Resonance (
1
H NMR) Spectroscopy
ASTM F2260-03 (Reapproved 2008).
15-33
Standard 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
.
15-34
Standard 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
.
15-35
Standard Guide for Characterization of Hydrogels used in Regenerative Medicine
ASTM F2900-11.
15-36
Standard 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]
BILLING CODE 4160-01-P
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