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Notice

Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 011

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: 011” (Recognition List Number: 011), 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: 011” to the Division of Small Manufacturers 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 database for the current list of FDA recognized consensus standards, including Recognition List Number: 011 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 Start Printed Page 59241Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext.156.

End Further Info End Preamble Start Supplemental Information

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 will implement its standard recognition program and provided the initial list of FDA recognized consensus 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), and June 18, 2004 (69 FR 34176), FDA modified its initial list of FDA recognized consensus standards. These notices described 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 Recognition List Number: 011

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: 011” 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
1ASTM F920-93 (1999), Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With HumansWithdrawn and replaced with newer version50
2ASTM F1100-90 (1997), Standard Specification for Ventilators Intended for Use in Critical CareWithdrawn and replaced with newer version51
5ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory CareWithdrawn and replaced with newer version52
6ASTM F1464-93 (1999), Standard Specification for Oxygen Concentrators for Domiciliary UseWithdrawn and replaced with newer version53
8PVHO-1-2002, Safety Standard for Pressure Vessels for Human OccupancyWithdrawn and replaced with newer version54
23ASTM F1054-01, Standard Specification for Conical FittingsWithdrawn and replaced with newer version55
24ASTM F1456-01, Standard Specification for Minimum Performance and Safety Requirements for CapnometersWithdrawn and replaced with newer version59
25ASTM F1462-93, Specification for Oxygen AnalyzersWithdrawn
34ASTM PS127: 2000, Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency ApplicationsWithdrawn
40CGA V-7.1: 1997 (reaffirmed 2003), Standard Method for Determining Cylinder Valve Outlet Connections for Medical GasesWithdrawn and replaced with newer version56
45ASTM 1101-90 (2003) e1, Standard Specification for Ventilators Intended for Use During AnesthesiaWithdrawn and replaced with newer version57
B. Cardiovascular/Neurology
Start Printed Page 59242
1ANSI/AAMI EC12: 2000, Disposable Electrocardiogram (ECG) ElectrodesWithdrawn and replaced with newer version52
4AAMI SP10: 1992, Electronic or Automated SphygmomanometersChange in processes affected and contact person
44ANSI/AAMI BP22: 1994 (R2001), Blood Pressure TransducersChange in processes affected and contact person
C. Dental/Ear, Nose, and Throat
22ASTM/F1377-92, Standard Specification for Cobalt-Chromium-Molybdenum Powder for Coating of Orthopaedic ImplantsTransfer to materials
42ANSI/ADA Specification No. 3: 1994, Dental Impression CompoundWithdrawn
43ANSI/ADA Specification No. 5: 1997, Dental Casting AlloysChange date of standard
44ANSI/ADA Specification No. 11: 1997, Agar Impression MaterialWithdrawn and replaced with newer version110
45ANSI/ADA Specification No. 13: 1999, Dental Cold-Curing Repair ResinWithdrawn and replaced with newer version111
48ANSI/ADA Specification No. 16: 1999, Dental Impression Paste Zinc Oxide-Eugenol MaterialsWithdrawn and replaced with newer version112
51ANSI/ADA Specification No. 20: 1995, Dental Duplicating MaterialWithdrawn and replaced with newer version113
55ANSI/ADA Specification No. 48: 1989, Ultraviolet Activator and Disclosing LightsWithdrawn and replaced with newer version114
67ISO 6871-1: 1994, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys—Technical Corrigendum 1: 1998Title correction
80ISO 9917-1: 2003, Dental Water Based Cements—Part 1: Powder/Liquid Acid-Base Cements—first editionWithdrawn and replaced with newer version115
81ISO 10139-1: 1999, Dentistry—Resilient Lining Materials for Removable Dentures—Part 1: Short-Term MaterialsWithdrawn and replaced with newer version116
90ANSI/ASA S3.39: 1987 (R2002), Specification for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)Change date of standard
103ANSI/ADA Specification No. 12: 2002, Denture Base PolymersWithdrawn and replaced with newer version117
105ANSI/ADA Specification No. 75: 1997 (R2003), Resilient Lining Materials for Removable Dentures—Part 1: Short-Term MaterialsTitle correction
106ANSI/ADA Specification No. 82: 2003, Dental Reversible/Irreversible Hydrocolloid Impression Material SystemWithdrawn and replaced with newer version119
108ISO 10139-2: 1999, Dentistry—Soft Lining Materials for Removable Dentures—Part 2: Materials for Long-Term UseWithdrawn and replaced with newer version120
D. General
10AAMI/ISO 14971-1, Medical Devices—Risk Management—Part 1: Application of Risk AnalysisWithdrawn
21CEN EN 1441: 1997, Medical Devices—Risk ManagementWithdrawn
E. In Vitro Diagnostic
23NCCLS H1-A5, Tubes and Additives for Venous Blood Specimen Collection; Approved StandardWithdrawn and replaced with newer version102
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69NCCLS H3-A5, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved StandardWithdrawn and replaced with newer version103
24NCCLS H7-A3, Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—third editionWithdrawn and replaced with newer version104
33NCCLS H30-A2, Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—second editionWithdrawn and replaced with newer version105
57NCCLS M2-A8, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—eighth editionWithdrawn and replaced with newer version106
75NCCLS M11-A6, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, Approved Standard—sixth editionWithdrawn and replaced with newer version107
56NCCLS M7-A6, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—sixth editionWithdrawn and replaced with newer version108
F. Materials
5ASTM F138-03, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)Withdrawn and replaced with newer version76
6ASTM F139-03, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673)Withdrawn and replaced with newer version77
7ASTM F560-04, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)Withdrawn and replaced with newer version78
13ASTM F648-00e1, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsChange date of standard
16ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant MaterialsChange in processes affected
19ASTM F961-03, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)Withdrawn and replaced with newer version79
21ASTM F1088-04, Standard Specification for Beta-Tricalcium Phosphate for Surgical ImplantationWithdrawn and replaced with newer version80
33ASTM F1609-03, Standard Specification for Calcium Phosphate for Coatings for Implantable MaterialsWithdrawn and replaced with newer version81
34ASTM F1659-95, Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic SubstratesChange in processes affected
35ASTM F1713-03, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant ApplicationsWithdrawn and replaced with newer version82
40ASTM F2063-00, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical ImplantsChange in extent of recognition, contact person, and processes affected
42ASTM F2119-01, Standard Test Method for Evaluation of MR Image Artifacts From Passive ImplantsChange in processes affected
48ASTM F899-02, Standard Specification for Stainless Steel for Surgical InstrumentsChange in processes affected
70ASTM F2052-02, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentWithdrawn
72ASTM F2213-04, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance EnvironmentChange in processes affected
Ortho #91ASTM F561-97 (2003), Practice for Retrieval and Analysis of Implanted Medical Devices and Associated TissuesTransferred to materials73
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Ortho #93ASTM 601-03, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsTransferred to materials94
Ortho #107ASTM F1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and Metal CoatingTransferred to materials84
Ortho/PM #113 Dental # 22ASTM F1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Transferred to materials74
Ortho #124ASTM F86-01, Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsTransferred to materials93
Ortho #131ASTM F1044-99, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsTransferred to materials83
Ortho #152ASTM F1160-00e1, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsTransferred to materials75
Ortho #160ASTM F629-02, Standard Practice for Radiography of Cast Metallic Surgical ImplantsTransferred to materials95
G. OB-GYN/Gastroenterology
16AAMI/ANSI ID54: 1996 (R)2001, Enteral Feeding Set Adapters and ConnectorsWithdrawn and replaced with newer version31
H. Orthopaedic
58ASTM F1781-03, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint ImplantsWithdrawn and replaced with newer version168
91ASTM F561-97, Practice for Retrieval and Analysis of Implanted Medical Devices and Associated TissuesTransferred to materials73
93ASTM F601-98, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsTransferred to materials94
107ASTM F1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and Metal CoatingsTransferred to materials84
111ASTM F1814-97a (2003), Standard Guide for Evaluating Modular Hip and Knee Joint ComponentsWithdrawn and replaced with newer version171
113ASTM F1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)Transferred to materials74
114ASTM F1798-97 (2003), Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis ImplantsWithdrawn and replaced with newer version172
115ASTM F1800-97 (2003), Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint ReplacementsWithdrawn and replaced with newer version173
120ASTM F382-99 (2003), Standard Specification and Test Method for Metallic Bone PlatesWithdrawn and replaced with newer version174
124ASTM F86-01, Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsTransferred to materials93
131ASTM F1044-99, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsTransferred to materials83
140ASTM F1582-98 (2003), Standard Terminology Relating to Spinal ImplantsWithdrawn and replaced with newer version175
145ASTM F565-00 (2003), Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsWithdrawn and replaced with newer version176
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152ASTM F1160-00e1, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsTransferred to materials75
160ASTM F629-02, Standard Practice for Radiography of Cast Metallic Surgical ImplantsTransferred to materials95
161ASTM F1264-03, Standard Specification and Test Methods for Intramedullary Fixation DevicesWithdrawn and replaced with newer version177
165ISO 7206-4: 2002, Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 4: Determination of Endurance Properties of Stemmed Femoral ComponentsWithdrawn
I. Physical Medicine
1ANSI/RESNA WC/volume—1998, Section 1: Determination of Static StabilityWithdrawn and replaced with newer version31
2ANSI/RESNA WC/volume 2—1998, Section 2: Determination of Dynamic Stability of Electric WheelchairsWithdrawn and replaced with newer version32
3ANSI/RESNA WC/volume 2—1998, Section 3: Test Methods and Requirements for the Effectiveness of BrakesWithdrawn and replaced with newer version33
4ANSI/RESNA WC/volume 2—1998, Section 4: Determination of Energy Consumption of Electric Wheelchairs and Scooters—Theoretical RangeWithdrawn and replaced with newer version34
5ANSI/RESNA WC/volume 1—1998, Section 5: Determination of Overall Dimensions, Mass, and Turning SpaceWithdrawn and replaced with newer version35
6ANSI/RESNA WC/volume 2—1998, Section 6: Determination of Maximum Speed, Acceleration, and Retardation of Electric WheelchairsWithdrawn and replaced with newer version36
7ANSI/RESNA WC/volume 1—1998, Section 7: Method of Measurement of Seating and Wheel DimensionsWithdrawn and replaced with newer version37
8ANSI/RESNA WC/volume 1—1998, Section 8: Requirements and Test Methods for Static, Impact, and Fatigue StrengthsWithdrawn and replaced with newer version38
9ANSI/RESNA WC/volume 2—1998, Section 9: Climatic Tests for Electric WheelchairsWithdrawn and replaced with newer version39
10ANSI/RESNA WC/volume 2—1998, Section 10: Determination of Obstacle-Climbing Ability of Electric WheelchairsWithdrawn and replaced with newer version40
11ANSI/RESNA WC/volume 1—1998, Section 11: Test DummiesWithdrawn and replaced with newer version41
12ANSI/RESNA WC/volume 1—1998, Section 13: Determination of Coefficient of Friction of Test SurfacesWithdrawn and replaced with newer version42
13ANSI/RESNA WC/volume 2—1998, Section 14: Power and Control Systems for Electric Wheelchairs—Requirements and Test MethodsWithdrawn and replaced with newer version43
14ANSI/RESNA WC/volume 1—1998, Section 15: Requirements for Information Disclosure, Documentation, and LabelingWithdrawn and replaced with newer version44
15ANSI/RESNA WC/volume 1—1998, Section 16: Resistance to Ignition of Upholstered Parts—Requirements and Test MethodsWithdrawn and replaced with newer version45
18ISO 7176-3: 2003, Wheelchairs—Part 3: Determination of Effectiveness of BrakesWithdrawn and replaced with newer version50
J. Radiology
39IEC 60601-2-17, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Remote-Controlled Automatically-Drive Gamma-Ray Afterloading Equipment (1989) Amendment No. 1 to IEC 601-2-17 (1996)Withdrawn
71NEMA UD 2-2004, Revision 3: Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentWithdrawn and replaced with newer version105
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72NEMA UD 3-2004, Revision 2: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound EquipmentWithdrawn and replaced with newer version100
78NEMA PS 3, Set: Digital Imaging and Communications in Medicine (DICOM) SetWithdrawn and replaced with newer version119
86IEC 60601-2-33 (2002-05), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical DiagnosisWithdrawn and replaced with newer version104
88IEC 60601-2-17 (2004-01), Medical Electrical Equipment—Part 2-17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading EquipmentWithdrawn and replaced with newer version118
94IEC 60731 Amendment 1 (2002-06), Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in RadiotherapyWithdrawn and replaced with newer version98
K. Sterility
16ANSI/AAMI ST35: 2003, Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical SettingsWithdrawn and replaced with newer version117
17ANSI/AAMI ST44: 1992, BIER/EO Gas VesselsWithdrawn
18ANSI/AAMI ST45: 1992, BIER/Steam VesselsWithdrawn
20ANSI/AAMI ST50: 2004, Dry Heat (Heated Air) SterilizersWithdrawn and replaced with newer version118
21ANSI/AAMI ST55: 2003, Table-Top Steam SterilizersWithdrawn and replaced with newer version119
48ANSI/AAMI ST40: 1992/(R)1998, Table-Top Dry Heat (Heated Air) Sterilizers and Sterility Assurance in Dental and Medical FacilitiesChange in relevant guidance and contact person
50ANSI/AAMI ST42: 1998, Steam Sterilization and Sterility Assurance Using Table-Top Sterilizers in Office-Based, Ambulatory-Care Medical, Surgical, and Dental FacilitiesContact person
52ANSI/AAMI ST59: 1999, Sterilization of Health Care Products—Biological Indicators—Part 1: General RequirementsChange in relevant guidance
53ANSI/AAMI ST66: 1999, Sterilization of Health Care Products—Chemical Indicators—Part 2: Class 2 Indicators for Air Removal Test Sheets and PacksContact person
56ASTM D3078: 2002, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionWithdrawn and replaced with newer version120
57ASTM D4169: 2004, Standard Practice for Performance Testing of Shipping Containers and SystemsWithdrawn and replaced with newer version121
58ASTM F88: 2000, Standard Test Method for Seal Strength of Flexible Barrier MaterialsWithdrawn and replaced with newer version122
63ASTM F1886: 1998 (2004), Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual InspectionReaffirmation
64ASTM F1929: 1998 (2004), Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationReaffirmation
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 FacilitiesContact person
74ANSI/AAMI ST60: 1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General RequirementsContact person
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: 2002Change in title, relevant guidance, and contact person
Start Printed Page 59247
91ASTM F2096: 2004, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)Withdrawn and replaced with newer version123
103AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical DevicesChange in relevant guidance
105ANSI/AAMI ST46: 2002, Steam Sterilization and Sterility Assurance in Health Care FacilitiesContact person
106USP 27: 2004, Biological Indicator for Dry Heat Sterilization, Paper CarrierWithdrawn and replaced with newer version124
107USP 27: 2004, Biological Indicator for Ethylene Oxide Sterilization, Paper CarrierWithdrawn and replaced with newer version125
108USP 27: 2004, Biological Indicator for Steam Sterilization, Paper CarrierWithdrawn and replaced with newer version126
109USP 27: 2004, <61> Microbial Limits TestWithdrawn and replaced with newer version127
110USP 27: 2004, <71> Microbiological Tests, Sterility TestsWithdrawn and replaced with newer version128
111USP 27: 2004, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL)Withdrawn and replaced with newer version129
112USP 27: 2004, <151> Pyrogen Test (USP Rabbit Test)Withdrawn and replaced with newer version130
113USP 27: 2004, <1211> Sterilization and Sterility Assurance of Compendial ArticlesWithdrawn and replaced with newer version131
114USP 27: 2004, <161> Transfusion and Infusion Assemblies and Similar Medical DevicesWithdrawn and replaced with newer version132
115USP 27: 2004, Biological Indicator for Steam Sterilization—Self-ContainedWithdrawn and replaced with newer version133
116ANSI/AAMI ST72: 2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch TestingChange in relevant guidance

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: 011, follows:

Table 2.

Item No.Title of StandardReference No. and Date
A. Anesthesia
58Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency ApplicationsASTM G175-03
B. Dental/ENT
121Dentistry—Dental Units—Part 2: Water and Air SupplyISO 7494-2: 2003
C. General Hospital/General Plastic Surgery
112Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care FacilitatesANSI/AAMI PB70: 2003
113Standard Specification for Performance of Materials Used in Medical Face MasksASTM F2100-04
D. Materials
Start Printed Page 59248
85Standard Test Method for Stereological Evaluation of Porous Coatings on Medical ImplantsASTM F1854-01
86Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate CoatingsASTM F1926-03
87Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the TaberT AbraserASTM F1978-00e1
88Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsASTM F2024-00
89Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant ApplicationsASTM F1873-98
90Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension LoadingASTM F2255-03
91Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension LoadingASTM F2256-03
92Standard Test Method for Strength Properties of Tissue Adhesives in TensionASTM F2258-03
96Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical ImplantsASTM 1635-95 (2000)
97Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant DevicesASTM F2129-04
98Standard Specification for Acrylic Bone CementASTM F451-99ae1
99Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal AnalysisASTM F2004-03
100Standard Terminology for Nickel-Titanium Shape Memory AlloysASTM F2005-00
101Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement MaterialsASTM F2118-03
102Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free RecoveryASTM F2082-03
E. OB-GYN/Gastroenterology
30Water Treatment Equipment for Hemodialysis ApplicationsANSI/AAMI RD62: 2001
F. Ophthalmic
33Contact Lens Care Products—Vocabulary, Performance Specifications, and Test MethodologyANSI Z80.18
G. Orthopaedic
178Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without TorsionASTM F1440-92 (2002)
179Standard Specification for Femoral Prostheses—Metallic ImplantsASTM F2068-03
H. Physical Medicine
46Determination of Performance of Stand-Up Type WheelchairsANSI/RESNA WC/volume 1—1998, section 20
47Set Up ProceduresANSI/RESNA WC/volume 1—1998, section 22
48Maximum Overall DimensionsANSI/RESNA WC/volume 1—1998, section 93
49Nomenclature, Terms, and DefinitionsANSI/RESNA WC/volume 1—1998, section 0
I. Radiology
Start Printed Page 59249
101Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General RequirementsANSI/ESNA RP-27.1.96
102Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement TechniquesANSI/ESNA RP-27.2.00
103Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Risk Group Classification and LabelingANSI/ESNA RP-27.3.96
106Optics and Optical Instruments—Lasers and Laser-Related Equipment—Lifetime of LasersISO 17526: 2003
107Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam Widths, Divergence Angle, and Beam Propagation FactorISO 11146: 1999
108Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of Optical Surfaces—Part 1: 1-on-1 TestISO 11254-1: 2000
109Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of Optical Surfaces—Part 2: S-on-1 TestISO 11254-2: 2001
110Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for Absorptance of Optical Laser Components (revision of ISO 11551: 1997)ISO 11551: 2003
111Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Methods for Laser Beam Power, Energy, and Temporal Characteristics (revision of ISO 11554: 1998)ISO 11554: 2003
112Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam Positional Stability (revision of ISO 11670: 1999)ISO 11670: 2003
113Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Polarization (revision of ISO 12005: 1999)ISO 12005: 2003
114Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Methods for Laser Beam Power (Energy) Density DistributionISO 13694: 2000
115Optics and Photonics—Lasers and Laser-Related Equipment—Test Methods for the Spectral Characteristics of LasersISO 13695: 2004
116Optics and Optical Instruments—Test Methods for Radiation Scattered by Optical ComponentsISO 13696: 2002
117Lasers and Laser-Related Equipment—Test Methods for Determination of the Shape of a Laser Beam Wavefront—Part 1: Terminology and Fundamental AspectsISO 15367-1: 2003
120Particular Requirements for the Safety of X-Ray Equipment for Computed TomographyIEC 60601-2-44 (ed. 2.1)
J. Sterility
134Resistometers Used for Characterizing the Performance of Biological and Chemical IndicatorsANSI/AAMI ST44: 2002
135Sterilization of Health Care Products—Requirements for the Development, Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry HeatANSI/AAMI ST63: 2002
136Sterilization of Health Care Products—Requirements for Products Labeled “Sterile”ANSI/AAMI ST67: 2003
137Sterilization of Health Care Products—VocabularyANSI/AAMI/ISO TIR 11139: 2002
138Aseptic Processing of Health Care Products—Part 2: FiltrationISO 13408-2: 2003
139Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air CleanlinessISO 14644-1: 1999
140Cleanrooms and Associated Controlled Environments—Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance With ISO 14644-1ISO 14644-2: 2000
141Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction, and Start-UpISO 14644-4: 2001
142Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 1: General Principles and MethodsISO 14698-1: 2003
143Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 2: Evaluation and Interpretation of Biocontamination DataISO 14698-2: 2003
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K. Tissue Engineering
5Standard Guide for Characterization and Testing of Hyaluronan as Starting Material Intended for Use in Biomedical and Tissue Engineered Medical Product ApplicationsASTM F2347-2003

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 document 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” via 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 document announcing “Modifications to the List of Recognized Standards, Recognition List Number: 011,” 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.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. Two copies of any mailed comments are to be submitted, 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: 011. These modifications to the list or recognized standards are effective upon publication of this document in the Federal Register.

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Dated: September 21, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. 04-22183 Filed 10-1-04; 8:45 am]

BILLING CODE 4160-01-S