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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 018

Document Details

Information about this document as published in the Federal Register.

Published Document

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

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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: 018” (Recognition List Number: 018), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

DATES:

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

ADDRESSES:

Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 018” to the Division of Small Manufacturers, Start Printed Page 52143International and Consumer Assistance, Center for Devices and Radiological Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your requests, or FAX your request to 301-443-8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.hhs.gov. This document may also be accessed on FDA's Web site at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfTopic/​cdrhnew.cfm. 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: 018 modifications and other standards related information.

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FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0533.

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SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the 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.

Federal Register Cite
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)

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: 018

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: 018” 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.

Old Item No.StandardChangeReplacement Item No.
A. Anesthesia
3ASTM F1161-88, Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas MachinesWithdrawn
15ISO 5361-4:1987, Tracheal Tubes—Part 4: Cole TypeContact person
35ISO 5361:1999, Anaesthetic and Respiratory Equipment—Tracheal Tubes and ConnectorsContact person
36ISO 5366-3:2001, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Pediatric Tracheostomy TubesContact person
42ISO 5360:2006, Anaesthetic Vaporizers—Agent Specific Filling SystemsWithdrawn and replaced with newer version74
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43ISO 5362:2006, Anaesthetic Reservoir BagsWithdrawn and replaced with newer version75
44ISO 5366-1:2000, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 1: Tubes and Connectors for Use in AdultsContact person
46ISO 5367:2000, Breathing Tubes Intended for Use With Anaesthetic Apparatus and VentilatorsContact person
50ASTM F920-93(1999): Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with HumansWithdrawn
55ASTM F1054-01: Standard Specification for Conical FittingsWithdrawn
61IEC 60601-2-13(2003-05), Medical Electrical Equipment—Part 2-13: Particular Requirements for the Safety and Essential Performance of Anaesthetic SystemsContact person
62ISO 5356-1:2004, Anaesthetic and Respiratory Equipment—Conical Connectors: Part 1: Cones and SocketsContact person
B. Biocompatibility
21AAMI / ANSI / ISO 10993-11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic ToxicityContact person
63AAMI / ANSI / ISO 10993-6:1995/(R) 2001, Biological Evaluation of Medical Devices—Part 6: Test for Local Effects After ImplantationContact person
64AAMI / ANSI / ISO 10993-5:1999, Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro CytotoxicityContact person
68ASTM F719-81(2002)e1: Standard Practice for Testing Biomaterials in Rabbits for Primary Skin IrritationContact person
70ASTM F750-87 (2002)e1: Standard Practice for Evaluating Material Extracts by Systemic Injection in the MouseContact person
71ASTM F1408-02e1: Standard Practice for Subcutaneous Screening Test for Implant MaterialsContact person
83ASTM E1262-88(2003): Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation AssayContact person
84ASTM E1263-97(2003): Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow ErythrocytesContact person
85ASTM E1280-97 (2003): Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell MutagenicityContact person
87AAMI / ANSI / ISO 10993-10:2002, Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and SensitizationContact person
88AAMI / ANSI / ISO 10993-12: 2002(E), Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference materialsContact person
89ASTM F749-98 (2002)e2: Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the RabbitContact person
90ASTM E1397-91(2003): Standard Practice for the in vitro Rat Hepatocyte DNA Repair AssayContact person
91ASTM E1398-91(2003): Standard Practice for the in vivo Rat Hepatocyte DNA Repair AssayContact person
92ASTM F748-04: Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesContact person
93ASTM F763-04: Standard Practice for Short-Term Screening of Implant MaterialsContact person
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94ASTM F981-04: Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and BoneContact person
97ASTM F1983-99(2003): Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant ApplicationsContact person
98AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices—Part 1: Evaluation and TestingContact person
99ASTM F1904-98(2003): Standard Practice for Testing the Biological Responses to Particles In VivoContact person
100ASTM E1372-95(2003): Standard Test Method for Conducting a 90-Day Oral Toxicity Study in RatsContact person
106ASTM F619-03: Standard Practice for Extraction of Medical PlasticsContact person
109USP 29-NF21 Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact TestContact person
110USP 29-NF21 Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution TestContact person
111USP 29-NF21 Biological Tests <88>, Biological Reactivity Tests, In Vivo, Procedure—Preparation of SampleContact person
112USP 29-NF21 Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous TestContact person
113USP 29-NF21 Biological Tests <88>, Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection TestContact person
114ASTM F1877-05: Standard Practice for Characterization of ParticlesContact person
115ASTM F895-84(2006): Standard Test Method for Agar Diffusion cell Culture Screening for CytotoxicityContact person
116ASTM F1439-03: Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant MaterialsContact person
C. General
2IEC 60601-1, Medical electrical equipment — Part 1: General requirements for safetyWithdrawn
11ISO 2859-1:1999: Sampling Procedures for Inspection By Attributes—Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL)for Lot-by-Lot InspectionWithdrawn and replaced with newer year version37
14ANSI/ASQ Z1.4-2003: Sampling Procedures and Tables for Inspection by AttributesWithdrawn and replaced with newer year version38
22ISO 2768-1: 1989, General Tolerances—Part 1: Tolerances for Linear and Angular Dimensions Without Individual Tolerance IndicationsContact name
23ISO 2768-2: 1989, General Tolerances—Part 2: Geometrical Tolerances for Features Without Individual Tolerance IndicationsContact name
24IEC 60812, edition 2.0: 2006-01, Analysis Technique for System Reliability—Procedure for Failure Mode and Effects AnalysisWithdrawn and replaced with newer year version39
26ISO 14971:2007: Medical devices—Application of Risk Management to Medical DevicesWithdrawn and replaced with newer year version40
28IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment—Part 1-2: General Requirements for Safety; Electromagnetic Compatibility—Requirements and TestsExtent of recognition
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30AAMI/ANSI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests. (The AAMI/ANSI/IEC 60601-1-2:2001 is the U.S. version of IEC 60601-1-2:2001 with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment.)Title change Type of standard Extent of recognition
34IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))Extent of recognition
35AAMI/ANSI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601-1-2:2001 is the U.S. version of IEC 60601-1-2:2001, with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment.)Extent of recognition
D. General Hospital/ General Plastic Surgery
18ISO 8537:1991 Sterile Single-use Syringes, With or Without Needle, for InsulinWithdrawn duplicate
20ISO 10555-1-1995 Sterile, Single-use Intravascular Catheters—Part 1: General RequirementsWithdrawn duplicate
46IEC 60601-2-2 2006 Medical Electrical Equipment—Part 2-2: Particular Requirements for the Safety of High Frequency Surgical EquipmentWithdrawn and replaced with newer version197
69ISO 9626-1991: Stainless Steel Needle Tubing for the Manufacture of Medical DevicesWithdrawn duplicate
72ISO 10555-5 1996-06-15 Sterile, Single-use Intravascular Catheters—Part 5: Over-needle Peripheral CathetersWithdrawn duplicate
96ASTM F2101-07 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus AureusWithdrawn and replaced with newer version199
113ASTM F2100-07 Standard Specification for Performance of Materials Used in Medical Face MasksWithdrawn and replaced with newer version198
108ASTM F754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod ShapesTransferred to materials
109ASTM F881-94(2006) Standard Specification for Silicone Elastomer Facial ImplantsWithdrawn and replaced with newer version185
128ASTM F1670-07 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodWithdrawn and replaced with newer version186
130ASTM F1671-07 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test SystemWithdrawn and replaced with newer version187
151USP 30:2007 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version188
152USP 30<11>: 2007 Sterile Sodium Chloride for IrrigationWithdrawn and replaced with newer version189
153USP 30:2007 Absorbable Surgical SutureWithdrawn and replaced with newer version190
154USP 30<881>:2007 Tensile StrengthWithdrawn and replaced with newer version191
155USP 30<861>:2007 Sutures—DiameterWithdrawn and replaced with newer version192
156USP 30<871>:2007 Sutures Needle AttachmentWithdrawn and replaced with newer version193
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157USP 30<11>: 2007 Sterile Water for IrrigationWithdrawn and replaced with newer version194
158USP 30<11>: 2007 Heparin Lock Flush SolutionWithdrawn and replaced with newer version195
159USP 30<11>: 2007 Sodium Chloride InjectionWithdrawn and replaced with newer version196
181ASTM F1862-07: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)Withdrawn and replaced with newer version184
E. Materials
2ASTM F75-07: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)Withdrawn and replaced with newer year version137
15ASTM F745-07: Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant ApplicationsWithdrawn and replaced with newer year version138
26ASTM F1314-07: Standard Specification for Wrought Nitrogen Strengthened 22 Chromium—13 Nickel—5 Manganese—2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)Withdrawn and replaced with newer year version139
37ASTM F1813-06: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120)Withdrawn and replaced with newer year version140
43ASTM F2146-07: Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)Withdrawn and replaced with newer year version141
67ISO 7153-1:1991/Amd. 1:1999, Surgical Instruments—Metallic Materials—Part 1: Stainless SteelContact person
87ASTM F1978-00(2007)e2: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber AbraserWithdrawn and replaced with newer year version142
89ASTM F1873-98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant ApplicationsWithdrawn
106ASTM F648-07: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsWithdrawn and replaced with newer year version143
128ASTM F2213-06: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance EnvironmentTitle
GH/GPS 108ASTM F754-00: Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod ShapesTransferred from GH/GPS to Materials144
F. OB-GYN/Gastroenterology
20ISO 8600-3:1997 Amendment 1 2003, Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with OpticsWithdraw duplicate
32ASTM D3492-03 Standard Specification for Rubber Contraceptives (Male Condoms)Extent of recognition, processes impacted, relevant guidance
33ASTM F623-99(2006) Standard Performance Specification for Foley CatheterWithdrawn and replaced with newer version44
34ISO 4074:2002/Cor.1:2003(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1Extent of recognition, relevant guidance
G. Ophthalmic
1ISO 9338:1996 Optics and Optical Instruments—Contact Lenses—Determination of the DiametersWithdrawn
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2ISO 9339-1:1996 Optics and Optical Instruments—Contact Lenses—Determination of the Thickness—Part 1: Rigid Contact LensesWithdrawn
4ISO 9341:1996 Optics and Optical Instruments—Contact Lenses—Determination of Inclusions and Surface Imperfections for Rigid Contact LensesWithdrawn
7ISO 9913-1:1996 Optics and Optical Instruments—Contact Lenses—Part 1: Determination of Oxygen Permeability and Transmissibility with the FATT MethodWithdrawn
8ISO 10338:1996 Optics and Optical Instruments—Contact Lenses—Determination of CurvatureWithdrawn
9ISO 10339:1997 Ophthalmic Optics—Contact Lenses—Determination of Water Content of Hydrogel LensesWithdrawn
10ISO 10340:1995 Optics and Optical Instruments—Contact Lenses—Method for Determining the Extractable SubstancesWithdrawn
11ISO 10344:1996 Optics and Optical Instruments—Contact Lenses—Saline Solution for Contact Lens TestingWithdrawn
16ISO 9913-2:2000 Optics and Optical Instruments—Contact Lenses—Part 2: Determination of Oxygen Permeability and Transmissibility by the Coulometric MethodWithdrawn
17ISO 10939:2007 Ophthalmic Instruments—Slit-lamp MicroscopesWithdrawn and replaced with newer version35
19ISO 11539:1999 Ophthalmic Optics—Contact Lenses—Classification of Contact Lenses and Contact Lens MaterialsWithdrawn
22ISO 11979-3:2006 Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test MethodsWithdrawn and replaced with newer version36
25ISO 12865:2006 Ophthalmic Instruments—RetinoscopesWithdrawn and replaced with newer version39
27ISO 11979-7:2006 Ophthalmic Implants—Intraocular Lenses—Part 7: Clinical InvestigationsWithdrawn and replaced with newer version41
H. Orthopedic/ Physical Medicine
121ISO 7207-1:1994, Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 1: Classification, Definitions and Designation of DimensionsWithdrawn
I. Radiology
57 & 132IEC 60731 (1997), (2002) Amendment 1, Medical Electrical Equipment—Dosimeters with Ionization Chambers as Used in RadiotherapyWithdrawn and combine162
59IEC 61168:1993, Radiotherapy Simulators—Functional Performance CharacteristicsContact person
63IEC 60601-2-43—Ed. 1.0, Medical Electrical Equipment—Part 2-43: Particular Requirements for the Safety of X-ray Equipment for Interventional ProceduresContact person
91IEC 60601-2-8 (1997-08), Amendment 1—Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Therapeutic X-ray Equipment Operating in the Range of 10 kV to 1 MVWithdrawn duplicate
103ANSI / IESNA RP-27.3-1996, Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and LabelingTitle
130 & 148IEC 60601-2-37 (2004), (2005) Amendment 2, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring EquipmentWithdrawn and combine164
131IEC 61217 2002:, Radiotherapy Equipment—Coordinates, Movements, and Scales Consolidated Ed. 1.1Contact person
Start Printed Page 52149
133IEC 60601-2-11 (1997), (2004) Amendment 1, Medical Electrical Equipment—Part 2-11: Particular Requirements for the Safety of gamma Beam Therapy EquipmentTitle
145IEC 61674 (1997), (2002) Amendment 1, Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-conductor Detectors as Used in X-ray Diagnostic ImagingContact person
J. Sterility
28ANSI/AAMI/ISO 11737-1:2006, Sterilization of Medical Devices—Microbiological Methods—Part 1: Determination of a Population of Microorganisms on Products, 2nd ed.Withdrawn and replaced with newer version227
47ANSI/AAMI ST37:1996, Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate UseWithdrawn
49ANSI/AAMI ST41:1999/(R) 2005, Ethylene Oxide Sterilization in Health Care Facilities: Safety and EffectivenessReaffirmation
50ANSI/AAMI ST42:1998, Steam Sterilization and Sterility Assurance Using Table-top Sterilizers in Office-based, Ambulatory-care Medical, Surgical, and Dental Facilities.Withdrawn
52ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators—Part 1: GeneralWithdrawn
53ANSI/AAMI ST66:1996, Sterilization of Health Care Products—Chemical Indicators—Part 2: Indicators for Air Removal Test Sheets and PacksContact person
54ANSI/AAMI/ISO 11737-2:1998, Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in the Validation of a Sterilization ProcessContact person
60ASTM F1327:1998, Standard Terminology Relating to Barrier Materials for Medical PackagingContact person
63ASTM F1886: 1998 (2004), Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual InspectionContact person
64ASTM F1929:1998 (2004), Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationContact person
72ANSI/AAMI ST33:1996, Guidelines for the Selection and Use of Reusable Rigid Sterilization Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care FacilitiesWithdrawn
75ANSI/AAMI/ISO 11137:1994, Sterilization of Health Care Products—Requirements for Validation and Routine Control—Radiation Sterilization and ANSI/AAMI/ISO 11137:1994 (Amendment 1:2002)Withdrawn
77ANSI/AAMI ST24:1999/(R) 2005, Automatic, General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for use in Health Care Facilities, 3rd ed.Reaffirmation
86ASTM F1980:2002, Standard Guide for Accelerated Aging of Sterile Medical Device PackagesContact person
88ANSI/AAMI/ISO 14937:2000, 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
90ASTM F2095-01, Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining PlatesContact person
105ANSI/AAMI ST46:2002, Steam Sterilization and Sterility Assurance in Health Care FacilitiesWithdrawn
116ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingContact person
Start Printed Page 52150
117ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical SettingsExtent of recognition
120ASTM D3078:2002, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionContact person
123ASTM F2096-04, Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)Contact person
134ANSI/AAMI ST44:2002, Resistometers Used for Characterizing the Performance of Biological and Chemical IndicatorsWithdrawn
135ANSI/AAMI ST63:2002, Sterilization of Health Care Products—Requirements for the Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry heatExtent of recognition
136ANSI/AAMI ST67:2003, Sterilization of Health Care Products—Requirements for Products Labeled ‘sterile’Contact person
137ANSI/AAMI/ISO TIR 11139:2006, Sterilization of Health Care Products—VocabularyWithdrawn and replaced with newer version221
144ASTM F2203-02e1, Standard Test Method for Linear Measurement Using Precision Steel RuleContact person
145ASTM F2217-02, Standard Practice for Coating/Adhesive Weight DeterminationContact person
146ASTM F2227-02, Standard Test Method of Leaks in Non-sealed and Empty Medical Packaging Trays by C02 Tracer Gas MethodContact person
147ASTM F2228-02, Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas MethodContact person
148ASTM F2250-03, Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging MaterialsContact person
149ASTM F2251-03e1, Standard Test Method for Thickness Measurement of Flexible Packaging MaterialContact person
150ASTM F2252-03, Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using TapeContact person
163ANSI/AAMI/ISO 11737-3:2004, Sterilization of Medical Devices—Microbiological Methods—Part 3: Guidance on Evaluation and Interpretation of Bioburden DataWithdrawn
167ASTM F2097-05, Standard Guide for Design and Evaluation of Primary Packaging for Medical ProductsContact person
168ASTM F2338-05, Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay MethodContact person
169ASTM F2391-05, Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer GasContact person
170ASTM F2475-05, Standard Guide for Biocompatibility Evaluation of Medical Device Packaging MaterialsContact person
171ANSI/AAMI/ISO 15882:2003, Chemical Indicators—Guidance on the Selection, Use, and Interpretation of ResultsContact person
172AOAC 6.2.01:2006, Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution MethodWithdrawn and replaced with newer version211
173AOAC 6.2.02:2006, Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version212
174AOAC 6.2.03:2006, Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version213
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175AOAC 6.2.04:2006, Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use-Dilution MethodWithdrawn and replaced with newer version214
176AOAC 6.2.05:2006, Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa, Hard Surface Carrier Test MethodWithdrawn and replaced with newer version215
177AOAC 6.2.06:2006, Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution MethodWithdrawn and replaced with newer version216
178AOAC 6.3.02:2006, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytesWithdrawn and replaced with newer version217
179AOAC 6.3.05:2006, Official Method 966.04, Sporicidal Activity of Disinfectants, Method IWithdrawn and replaced with newer version218
180AOAC 6.3.06:2006, Official Method 965.12, Tuberculocidal Activity of DisinfectantsWithdrawn and replaced with newer version219
181ANSI/AAMI ST58:2005, Chemical Sterilization and High-Level Disinfection in Health Care FacilitiesTitle, Devices affected and Relevant guidance
182USP 30:2007, Biological Indicator for Dry-Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version202
183USP 30:2007, Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version203
184USP 30:2007, Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version204
185USP 30:2007, <61> Microbial Limits TestWithdrawn and replaced with newer version205
186USP 30:2007, <71> Microbiological Tests, Sterility TestsWithdrawn and replaced with newer version206
187USP 30:2007, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL)Withdrawn and replaced with newer version207
188USP 30:2007, <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version208
189USP 30:2007, <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version209
190USP 30:2007, Biological Indicator for Steam Sterilization, Self-ContainedWithdrawn and replaced with newer version210
193ANSI/AAMI/ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3rd ed.Contact person
194ANSI/AAMI/ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1st ed.Contact person
196ASTM F1140-2005, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical ApplicationsContact person
197ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)Contact person
198ASTM F2054-05, Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining PlatesContact person
199ASTM D4169-05, Standard Practice for Performance Testing of Shipping Containers and SystemsContact person
200ASTM F88-2005, Standard Test Method for Seal Strength of Flexible Barrier MaterialsContact person
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K. Tissue Engineering
3ASTM F2212-02(2007)e1, 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 version11

III. Listing of New Entries

In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 018.

Table 3.

Item No.Title of StandardReference No. and Date
A. Anesthesia
72Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency ResuscitatorsISO 10651-5:2006
73Lung Ventilators—Part 4: Particular Requirements for Operator Powered ResuscitatorsISO 10651-4:2002
B. Biocompatibility
117Biological Evaluation of Medical Devices—Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive ToxicityANSI/AAMI/ISO 10993-3: 2003
C. Dental/ ENT
144Dentistry-Mercury and Alloys for Dental AmalgamISO 24234: 2004(E)
D. OB-GYN/Gastroenterology
45Standard Test Methods for Enteral Feeding Devices with a Retention BalloonASTM F2528-06
E. Ophthalmic
42Ophthalmic Implants—Intraocular lenses—Part 2: Optical Properties and Test MethodsISO 11979-2:1999/Corrigendum1:2003
43Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products with Contact LensesISO 11981:1999/ Corrigendum1:2005
45Ophthalmic Optics—Contact Lenses—Part 2: TolerancesISO 18369-2:2006
46Ophthalmic Optics—Contact Lenses—Part 3: Measurement MethodsISO 18369-3:2006
48Ophthalmic Implants—Intraocular Lenses—Part 5: BiocompatibilityISO 11979-5:2006
49Ophthalmic Implants—Intraocular Lenses—Part 9: Multifocal Intraocular LensesISO 11979-9:2006
50Ophthalmic implants—Intraocular lenses—Part 10: Phakic Intraocular LensesISO 11979-10:2006
51Ophthalmic Instruments—Fundamental Requirements and Test Methods Part 2: Light Hazard ProtectionISO 15004-2:2007
F. Radiology
165“Quality Control Manual” Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital MammographyNEMA XR 22-2006
166“Quality Control Manual” Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital MammographyNEMA XR 23-2006
G. Sterility
201Containment Devices for Reusable Medical Device SterilizationANSI/AAMI ST77:2006
220Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care FacilitiesANSI/AAMI ST79:2006
Start Printed Page 52153
222Sterilization of Health Care Products—Biological and Chemical Indicators—Test EquipmentANSI/AAMI/ISO 18472:2006
223Sterilization of Health Care Products—Biological Indicators—Part 1: General RequirementsANSI/AAMI/ISO 11138-1:2006
224Sterilization of Health Care Products—Radiation—Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical DevicesANSI/AAMI/ISO 11137-1:2006
225Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization DoseANSI/AAMI/ISO 11137-2:2006
226Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric AspectsANSI/AAMI/ISO 11137-3:2006
H. Tissue Engineering
9Standard Guide for Classification of Therapeutic Skin SubstitutesASTM F2311-06
10Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular CartilageASTM F2451-05

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 Web 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 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. The Center for Devices and Radiological Health (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: 018” will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/​cdrh.

You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at http://www.fda.gov/​cdrh/​stdsprog.html.

This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfTopic/​cdrhnew.cfm.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 018. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.

Start Signature

Dated: August 30, 2007.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

End Signature End Supplemental Information

[FR Doc. E7-18021 Filed 9-11-07; 8:45 am]

BILLING CODE 4160-01-S