Skip to Content

Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013

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.

Start Preamble

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication entitled “Modifications to the List of Recognized Standards, Recognition List Number: 013” (Recognition List Number: 013), 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 on a 3.5” diskette of “Modifications to the List of Recognized Standards, Recognition List Number: 013” to the Division of Small Manufacturers, International 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.gov. This document may also be accessed on FDA's Internet site at http://www.fda.gov/​cdrh/​fedregin.html. See section VI of this document for electronic access to the searchable Start Printed Page 67714database for the current list of FDA recognized consensus standards, including Recognition List Number: 013 modifications and other standards related information.

Start Further Info

FOR FURTHER INFORMATION CONTACT:

Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 12720 Twinbrook Pkwy., MD 20857, 301-827-0021.

End Further Info End Preamble Start Supplemental 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.

In Federal Register notices published on 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), and October 4, 2004 (69 FR 59240), FDA modified its initial list of FDA recognized consensus standards. 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: 013

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: 013” to identify these current modifications.

In table 1 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 1.

Old Item No.StandardChangeReplacement Item No.
A. Anesthesia
52ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory CareWithdrawn
B. Biocompatibility
1ASTM E1262-88 (2003), Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation AssayWithdrawn and replaced with newer version83
2ASTM E1263-97 (2003), Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow ErythrocytesWithdrawn and replaced with newer version84
3ASTM E1280-97 (2003), Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell MutagenicityWithdrawn and replaced with newer version85
19AAMI/ANSI/ISO10993-10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and SensitizationWithdrawn and replaced with newer version86
20AAMI/ANSI/ISO10993-10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization—Maximization Sensitization TestWithdrawn and replaced with newer version87
21AAMI/ANSI/ISO10993-11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic ToxicityExtent of Recognition and Relevant Guidance
28AAMI/ANSI/ISO10993-12:2002(E), Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference MaterialsWithdrawn and replaced with newer version88
34ASTM F749-98 (2002)e2, Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the RabbitWithdrawn and replaced with newer version89
Start Printed Page 67715
37ASTM E1397-91 (2003), Standard Practice for the In Vitro Rat Hepatocyte DNA Repair AssayWithdrawn and replaced with newer version90
38ASTM E1398-91 (2003), Standard Practice for the In Vivo Rat Hepatocyte DNA Repair AssayWithdrawn and replaced with newer version91
39ASTM F748-04, Standard Practice for Selecting Generic Biological Test Methods for Materials and DevicesWithdrawn and replaced with newer version92
40ASTM F763-04, Standard Practice for Short-Term Screening of Implant MaterialsWithdrawn and replaced with newer version93
41ASTM F981-04, Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and BoneWithdrawn and replaced with newer version94
42ASTM F1984-99 (2003), Standard Practice for Testing for Whole Complement Activation in Serum by Solid MaterialsWithdrawn and replaced with newer version95
43ASTM F1903-98 (2003), Standard Practice for Testing for Biological Responses to Particles In VitroWithdrawn and replaced with newer version96
45ASTM F1983-99 (2003), Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant ApplicationsWithdrawn and replaced with newer version97
51AAMI/ANSI/ISO10993-1: 2003(E), Biological Evaluation of Medical Devices—Part 1: Evaluation and TestingWithdrawn and replaced with newer version98
52ASTM F1904-98e1 (2003), Standard Practice for Testing for Biological Responses to Particles In VivoWithdrawn and replaced with newer version99
53ASTM E1372-95 (2003), Standard Test Method for Conducting a 90-Day Oral Toxicity Study in RatsWithdrawn and replaced with newer version100
70ASTM F750-87 (2002)e1, Standard Practice for Evaluating Material Extracts by Systemic Injection in the MouseRelevant guidance
74USP 28-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact TestWithdrawn and replaced with newer version101
75USP 28-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution TestWithdrawn and replaced with newer version102
76USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vivo Procedure—Preparation of SampleWithdrawn and replaced with newer version103
77USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous TestWithdrawn and replaced with newer version104
78USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Systemic Injection TestWithdrawn and replaced with newer version105
79ASTM F619-03, Standard Practice for Extraction of Medical PlasticsWithdrawn and replaced with newer version106
80ASTM F1877 (2003)e1, Standard Practice for Characterization of ParticlesWithdrawn and replaced with newer version107
81ASTM F1905 (2003)e1, Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause ImmunotoxicityWithdrawn and replaced with newer version108
B. Cardiovascular/Neurology
4ANSI/AAMI SP10:2002—Manual, Electronic, or Automated SphygmomanometersWithdrawn and replaced with newer version53
5ANSI/AAMI/ISO 7198:1998/2001(R) 2004, Cardiovascular Implants—Tubular vascular prosthesesWithdrawn and replaced with newer version54
Start Printed Page 67716
14ASTM F1830:05, Recommended Practice for Selection of Blood for In Vitro Hemolytic Evaluation of Blood PumpsWithdrawn and replaced with newer version55
15ASTM F1841:05, Recommended Practice for Assessment of Hemolysis in Continuous Flow Blood PumpsWithdrawn and replaced with newer version56
48ASTM F2129:04, Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesWithdrawn and replaced with newer version57
C. Dental/Ear, Nose, and Throat
29IEC 60601-2-18:2000 Amendment 1, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Endoscopic EquipmentWithdrawn and replaced with newer version122
40ANSI/ASA S3.6-2004, Specification for AudiometersWithdrawn and replaced with newer version123
41ANSI/ASA S3.22:2003, Specification of Hearing Aid CharacteristicsWithdrawn and replaced with newer version124
61ISO 1562:2004, Dentistry—Casting gold alloysWithdrawn and replaced with newer version125
82ISO 10477:2004, Dentistry—Polymer-based crown and bridge materialsWithdrawn and replaced with newer version126
D. General
16ASTM D903:1993, Test Methods for Peel or Stripping Strength of Adhesive BondsContact person
28IEC 60601-1-2, (Second Edition), Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and TestsExtent of recognition
30AAMI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001)Title and extent of recognition
2IEC 60601-1, Medical Electrical Equipment—Part 1: General Requirements for SafetyWithdrawn
4IEC 60601-1, Medical Electrical Equipment—Part 1: General Requirements for Safety, 1988; Amendment 1, l991-11, Amendment 2, 1995-03Contact person, devices affected and extent of recognition
E. General Hospital/General Plastic Surgery
18ISO 8537:1991 Sterile Single-Use Syringes, With or Without Needle, for InsulinContact person
38ASTM F1671-03: 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 System.Withdrawn and replaced with newer version130
48ASTM D6499-03 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its ProductsWithdrawn and replaced with newer version131
31 Ophthalmic 89 RadiologyISO 11810-1:2005: Lasers and Laser-Related Equipment—Test Method and Classification for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers—Part 1: Primary Ignition and PenetrationTransferred from Ophthalmic and Radiology132
97USP 28: 2005 Nonabsorbable Surgical SutureWithdrawn and replaced with newer version133
Start Printed Page 67717
98USP 28<11>: 2005 Sterile Sodium Chloride for IrrigationWithdrawn and replaced with newer version134
99USP 28: 2005 Absorbable Surgical SutureWithdrawn and replaced with newer version135
100USP 28<881>: 2005 Tensile StrengthWithdrawn and replaced with newer version136
101USP 28<861>: 2005 Sutures—DiameterWithdrawn and replaced with newer version137
102USP 28<871>: 2005 Sutures Needle AttachmentWithdrawn and replaced with newer version138
103USP 28<11>: 2005 Sterile Water for IrrigationWithdrawn and replaced with newer version139
104USP 28<11>: 2005 Heparin Lock Flush SolutionWithdrawn and replaced with newer version140
105USP 28<11>: 2005 Sodium Chloride InjectionWithdrawn and replaced with newer version141
11ISO 594-1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 1: General RequirementsTitle and contact person
13ISO 595-1:1986 Reusable All-Glass or Metal-and-Glass Syringes for Medical Use—Part 1: DimensionsTitle and contact person
14ISO 595-2:1987 Reusable All-Glass or Metal-and-Glass Syringes for Medical Use—Part 2: Design, Performance Requirements and TestsTitle and contact person
15ISO 7864:1993 Sterile Hypodermic Needles for Single UseContact person
16ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use—Part 1: Syringes for Manual UseTitle and contact person
62ISO 8536-6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion BottlesTitle and contact person
63ISO 8536-7-1999: Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations for Infusion BottlesContact Person
64ISO 8536-3-1999: Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion BottlesTitle and contact person
66ISO 8536-1-2000: Infusion equipment for medical use—Part 1: Infusion glass bottlesTitle and Contact Person
68ISO 7886-2-1996: Sterile Hypodermic Syringes for Single Use—Part 2: Syringes for Use With Power-Driven Syringe PumpsTitle and contact person;
69ISO 9626-1991: Stainless Steel Needle Tubing for the Manufacture of Medical DevicesTitle and contact person
70ASTM E825-98 (2003) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human TemperatureContact person
111IEC 60601-2-38 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Electrically Operated Hospital BedsContact person
119AAMI BF7: (R2002) Blood Transfusion Micro-FiltersContact person
120ASTM F1054-01: Standard Specification for Conical FittingsContact person
Start Printed Page 67718
121ISO 8536-2-2001: Infusion Equipment for Medical Use—Part 2: Closures for Infusion BottlesContact person
122ISO 8536-5-2004: Infusion Equipment for Medical Use—Part 5: Burette Infusion Sets for Single Use, Gravity FeedTitle and contact person
126ISO 8536-4-2004: Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity FeedContact person
127ISO 1135-4-2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single UseContact person
129ISO 594-2:1998 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 2: Lock FittingsContact person
F. In Vitro Diagnostic
65CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second EditionWithdrawn and replaced with new version110
54CLSI D12-A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved GuidelineProduct codes
G. Materials
9ASTM F563-00: Standard Specification for Wrought Cobalt-20 Nickel-20 Chromium-3.5 Molybdenum-3.5 Tungsten-5 Iron Alloy for Surgical Implant Applications (UNS R30563)Withdrawn
13ASTM F648-04: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsWithdrawn and replaced with newer version106
16ASTM F746-04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsWithdrawn and replaced with newer version107
25ASTM F1295-05: Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)Withdrawn and replaced with newer version108
34ASTM F1659-95: Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic SubstratesWithdrawn
72ASTM F2213-04: Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance EnvironmentTitle
73ASTM F561-05, Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated TissuesWithdrawn and replaced with newer version109
74ASTM F1377-04: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Withdrawn and replaced with newer version110
75ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsWithdrawn and replaced with newer version111
80ASTM F1088-04a: Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationTitle
83ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsWithdrawn and replaced with newer version112
84ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metal CoatingsWithdrawn and replaced with newer version113
Start Printed Page 67719
90ASTM F2255-05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension LoadingWithdrawn and replaced with newer version114
91ASTM F2256-05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension LoadingWithdrawn and replaced with newer version115
92ASTM F2258-05: Standard Test Method for Strength Properties of Tissue Adhesives in TensionWithdrawn and replaced with newer version116
93ASTM F86-04: Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsWithdrawn and replaced with newer version117
H. OB-GYN/Gastroenterology
1AAMI RD5:1992: Hemodialysis systemsWithdrawn
17ASTM D3492-03: Standard Specification for Rubber Contraceptives (Male Condoms)Withdrawn and replaced with newer version32
24ASTM F623-99e1: Standard Performance Specification for Foley CatheterWithdrawn and replaced with newer version33
26ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1Withdrawn and replaced with newer version34
27ASTM D6324-99a (Reapproved 2004): Standard Test Methods for Male Condoms Made From Synthetic MaterialsWithdrawn and replaced with newer version35
I. Ophthalmic
31ISO 11810:2002, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective CoversWithdrawn newer version recognized under General Hospital/ General Plastic Surgery
J. Orthopedic
126ASTM F366-04: Standard Specification for Fixation Pins and WiresWithdrawn and replaced with newer version180
159ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy ModelWithdrawn and replaced with newer version181
173ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint ReplacementsWithdrawn and replaced with newer version182
K. Radiology
1ANSI PH 2.43-1982: Method for Sensitometry/Medical X-Ray Screen-FilmContact person
2ANSI IT 1.48-1997 Photography (Films)—Medical Hard Copy Imaging Film-Dimensions and SpecificationsTitle and contact person
5ANSI PH 2.50-1983: Method/Sensitometry Direct Exposure Medical/DentalContact person
6IEC 60806 (R1984) Determination of the Maximum Symmetrical Radiation Field From a Rotating Anode X-ray Tube for Medical DiagnosisTitle and contact person
8IEC 60336 (R1993) Medical Electrical Equipment—X-ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal SpotsTitle
23NEMA XR 10-1986 (R2003) Measurement of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube Used for Medical DiagnosisReaffirmation
Start Printed Page 67720
34IEC 60601-2-7-1998 Medical Electrical Equipment—Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray GeneratorsTile and contact person
37IEC 60601-2-11-2004 Amendment 1—Medical electrical equipment—Part 2-11: Particular requirements for the Safety of Gamma Beam Therapy Equipment Withdrawn and Replaced With Newer Version133
52UL 544 (1998): Standard for Medical and Dental Equipment—Ed. 4.0Contact person
56IEC 61674-1997 Medical Electrical Equipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-ray Diagnostic ImagingWithdrawn
57IEC 60731-1997 Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in RadiotherapyTitle and devices affected
61UL 122 (1999): Standard for Photographic Equipment—Ed. 4.0Contact person
62UL 187 (1998): Standard for X-Ray Equipment—Ed. 7.0Contact person
79NEMA XR 7-1995 (R2000) High-Voltage X-Ray Cable Assemblies and ReceptaclesTitle and contact person
80NEMA XR 9-1984 (R1994, R2000) Power Supply Guidelines for X-Ray MachinesContact person
81NEMA XR 13-1990 (R1995, R2000) Mechanical Safety Standard for Power Driven Motions of Electromedical EquipmentContact person
82NEMA XR 14-1990 (R1995, R2000) Recommended Practices for Load Bearing Mechanical Assemblies Used in Diagnostic ImagingContact Person
89ISO 11810:2002 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective CoversWithdrawn Newer version recognized under General Hospital/General Plastic Surgery
107ISO 11146-1:2005 Lasers and Laser-Related Equipment—Test Methods for Laser Beam Widths, Divergence Angles and Beam Propagation Ratios—Part 1: Stigmatic and Simple Astigmatic BeamsWithdrawn and replaced with newer version134
119NEMA PS 3.1—3.18 Digital Imaging and Communications in Medicine (DICOM) SetTitle
126IEC 60601-2-28-1993 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis—Ed. 1.0Title and contact person
127IEC 60601-2-32-1994 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment—Ed. 1.0Title and contact person
129NEMA NU 1-2001 (Errata 2004): Performance Measurements of Scintillation CamerasTitle
131IEC 61217-2002 Radiotherapy Equipment—Coordinates Movements and Scales Consolidated Ed. 1.1Title
132IEC 60731-2002 Amendment 1—Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in RadiotherapyTitle and devices affected
L. Sterility
48ANSI/AAMI ST40:2004, Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Dental and Medical Facilities, 2edWithdrawn and replaced with newer version152
Start Printed Page 67721
52ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: GeneralTitle, relevant guidance, and contact person
70ANSI/AAMI/ISO 14161:2000, Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use, and Interpretation of Results, 2ed.Contact Person
71ANSI/AAMI ST8:2001, Hospital Steam SterilizersContact Person
77ANSI/AAMI ST24:1999, Automatic, General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities, 3ed.Title and contact person
116ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingRelevant guidance
117ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical SettingsRelevant guidance and contact person
119ANSI/AAMI ST55:2003, Table-Top Steam Sterilizers, 2ed.Correct title and contact person
124USP 28:2005, Biological Indicator for Dry Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version153
125USP 28:2005, Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version154
126USP 28:2005, Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version155
127USP28:2005, <61> Microbial Limits TestWithdrawn and replaced with newer version156
128USP 28:2005, <71>, Microbiological Tests, Sterility TestsWithdrawn and replaced with newer version157
129USP28:2005, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL)Withdrawn and replaced with newer version158
130USP28:2005 <151>, Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version159
131USP28:2005 <1211>, Sterilization and Sterility Assurance of Compendial ArticlesWithdrawn and replaced with newer version160
132USP28:2005 <161>, Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version161
133USP 28:2005, Biological Indicator for Steam Sterilization—Self-ContainedWithdrawn and replaced with newer version162

III. Listing of New Entries

The listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 013, follows:

Item No.Title of StandardReference No. and Date
A. Anesthesia
65Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas MonitorsISO 21647:2005
66Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical UseISO 9919:2005
Start Printed Page 67722
B. Dental/Ear, Nose, Throat
127Root Canal Files, Type H (Hedstrom)ANSI/ADA Specification No. 58:2004
128Dentistry—Elastomeric Impression MaterialsISO/4823:2000 Technical Corrigendum 1:2004
129Dentistry—Elastomeric Impression MaterialsANSI/ADA Specification No. 19:2000 Technical Corrigendum 1:2004
C. General
34Medical 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))IEC 60601-1-2:2004
35Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004)AAMI/IEC 60601-1-2:2001
D. General Hospital/General Plastic Surgery
142Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby IncubatorsANSI/AAMI II36:2004
143Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport IncubatorsANSI/AAMI II51:2004
E. In Vitro Diagnostic
109Laboratory Automation: Data Content for Specimen Identification; Approved StandardCLSI AUTO7-A:2004
111Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—Fourth EditionCLSI H21-A4:2003
112Point-of-Care Monitoring of Anticoagulation Therapy; Approved GuidelineCLSI H49-A:2004
113Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved GuidelineCLSI I/LA23-A:2004
114Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer SystemsCLSI LIS01-A:2003
115Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard—Second EditionCLSI LIS02-A2:2004
116Standard Guide for Selection of a Clinical Laboratory Information Management SystemCLSI LIS03-A:2003
117Standard Guide for Documentation of Clinical Laboratory Computer SystemsCLSI LIS04-A:2003
118Standard Specification for Transferring Clinical Observations Between Independent Computer SystemsCLSI LIS05-A:2003
119Standard Practice for Reporting Reliability of Clinical Laboratory Information SystemsCLSI LIS06-A:2003
120Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical LaboratoryCLSI LIS07-A:2003
121Standard Guide for Functional Requirements of Clinical Laboratory Information Management SystemsCLSI LIS08-A:2003
122Standard Guide for Coordination of Clinical Laboratory Services Within the Electronic Health Record Environment and Networked ArchitecturesCLSI LIS09-A:2003
Start Printed Page 67723
123Nucleic Acid Sequencing Methods in Diagnostic Laboratory MedicineCLSI MM9-A:2004
F. Materials
118Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance EnvironmentASTM F2503-05
G. OB-GYN/Gastroenterology
36Mechanical contraceptives—Reusable Natural and Silicone Rubber Contraceptive Diaphragms—Requirements and TestsISO 8009:2004(E)
H. Radiology
135Medical electrical equipment—Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment Ed. 2.0IEC 60601-2-5:2000
I. Sterility
163Sterilization of Medical Devices—Microbiological methods—Part 3: Guidance on Evaluation and Interpretation of Bioburden DataANSI/AAMI/ISO 11737-3:2004
164Sterilization of Medical Devices—Information To Be Provided by the Manufacturer for the Processing of Resterilizable Medical DevicesANSI/AAMI ST81:2004
165Cleanrooms and Associated Controlled Environments—Part 5: OperationsISO 14644-5:2004
166Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments)ISO 14644-7:2004
J. Tissue Engineering
6Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical ProductsASTM F2450-04
7Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate GelsASTM F2315-03

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 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

In order to receive “Guidance on the Recognition and Use of Consensus Standards” on your FAX machine, call the Center for Devices and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number 321 followed by the pound sign. Follow the remaining voice prompts to complete your request.

You may also 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 “Modifications to the List of Recognized Standards, Recognition List Number: 013” 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.

Start Printed Page 67724

This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/​cdrh/​fedregin.html.

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: 013. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.

Start Signature

Dated: October 10, 2005.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

End Signature End Supplemental Information

[FR Doc. 05-22267 Filed 11-7-05; 8:45 am]

BILLING CODE 4160-01-S