Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 011
Federal RegisterOct 4, 2004
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 011
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.
FOR FURTHER INFORMATION CONTACT:
Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and
Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext.156.
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.
Standard
Change
Replacement Item No.
A. Anesthesia
1
ASTM F920-93 (1999), Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans
Withdrawn and replaced with newer version
50
2
ASTM F1100-90 (1997), Standard Specification for Ventilators Intended for Use in Critical Care
Withdrawn and replaced with newer version
51
5
ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care
Withdrawn and replaced with newer version
52
6
ASTM F1464-93 (1999), Standard Specification for Oxygen Concentrators for Domiciliary Use
Withdrawn and replaced with newer version
53
8
PVHO-1-2002, Safety Standard for Pressure Vessels for Human Occupancy
Withdrawn and replaced with newer version
54
23
ASTM F1054-01, Standard Specification for Conical Fittings
Withdrawn and replaced with newer version
55
24
ASTM F1456-01, Standard Specification for Minimum Performance and Safety Requirements for Capnometers
Withdrawn and replaced with newer version
59
25
ASTM F1462-93, Specification for Oxygen Analyzers
Withdrawn
34
ASTM PS127: 2000, Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
Withdrawn
40
CGA V-7.1: 1997 (reaffirmed 2003), Standard Method for Determining Cylinder Valve Outlet Connections for Medical Gases
Withdrawn and replaced with newer version
56
45
ASTM 1101-90 (2003) e1, Standard Specification for Ventilators Intended for Use During Anesthesia
Withdrawn and replaced with newer version
57
B. Cardiovascular/Neurology
1
ANSI/AAMI EC12: 2000, Disposable Electrocardiogram (ECG) Electrodes
Withdrawn and replaced with newer version
52
4
AAMI SP10: 1992, Electronic or Automated Sphygmomanometers
Change in processes affected and contact person
44
ANSI/AAMI BP22: 1994 (R2001), Blood Pressure Transducers
Change in processes affected and contact person
C. Dental/Ear, Nose, and Throat
22
ASTM/F1377-92, Standard Specification for Cobalt-Chromium-Molybdenum Powder for Coating of Orthopaedic Implants
Transfer to materials
42
ANSI/ADA Specification No. 3: 1994, Dental Impression Compound
Withdrawn
43
ANSI/ADA Specification No. 5: 1997, Dental Casting Alloys
Change date of standard
44
ANSI/ADA Specification No. 11: 1997, Agar Impression Material
Withdrawn and replaced with newer version
110
45
ANSI/ADA Specification No. 13: 1999, Dental Cold-Curing Repair Resin
Withdrawn and replaced with newer version
111
48
ANSI/ADA Specification No. 16: 1999, Dental Impression Paste Zinc Oxide-Eugenol Materials
Withdrawn and replaced with newer version
112
51
ANSI/ADA Specification No. 20: 1995, Dental Duplicating Material
Withdrawn and replaced with newer version
113
55
ANSI/ADA Specification No. 48: 1989, Ultraviolet Activator and Disclosing Lights
Withdrawn and replaced with newer version
114
67
ISO 6871-1: 1994, Dental Base Metal Casting Alloys—Part 1: Cobalt-Based Alloys—Technical Corrigendum 1: 1998
Title correction
80
ISO 9917-1: 2003, Dental Water Based Cements—Part 1: Powder/Liquid Acid-Base Cements—first edition
Withdrawn and replaced with newer version
115
81
ISO 10139-1: 1999, Dentistry—Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials
Withdrawn and replaced with newer version
116
90
ANSI/ASA S3.39: 1987 (R2002), Specification for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
Change date of standard
103
ANSI/ADA Specification No. 12: 2002, Denture Base Polymers
Withdrawn and replaced with newer version
117
105
ANSI/ADA Specification No. 75: 1997 (R2003), Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials
Title correction
106
ANSI/ADA Specification No. 82: 2003, Dental Reversible/Irreversible Hydrocolloid Impression Material System
Withdrawn and replaced with newer version
119
108
ISO 10139-2: 1999, Dentistry—Soft Lining Materials for Removable Dentures—Part 2: Materials for Long-Term Use
Withdrawn and replaced with newer version
120
D. General
10
AAMI/ISO 14971-1, Medical Devices—Risk Management—Part 1: Application of Risk Analysis
Withdrawn
21
CEN EN 1441: 1997, Medical Devices—Risk Management
Withdrawn
E. In Vitro Diagnostic
23
NCCLS H1-A5, Tubes and Additives for Venous Blood Specimen Collection; Approved Standard
Withdrawn and replaced with newer version
102
69
NCCLS H3-A5, Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard
Withdrawn and replaced with newer version
103
24
NCCLS H7-A3, Procedure for Determining Packed Cell Volume by the Microhematocrit Method; Approved Standard—third edition
Withdrawn and replaced with newer version
104
33
NCCLS H30-A2, Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline—second edition
Withdrawn and replaced with newer version
105
57
NCCLS M2-A8, Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard—eighth edition
Withdrawn and replaced with newer version
106
75
NCCLS M11-A6, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically, Approved Standard—sixth edition
Withdrawn and replaced with newer version
107
56
NCCLS M7-A6, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—sixth edition
Withdrawn and replaced with newer version
108
F. Materials
5
ASTM 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 version
76
6
ASTM 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 version
77
7
ASTM F560-04, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
Withdrawn and replaced with newer version
78
13
ASTM F648-00e1, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Change date of standard
16
ASTM F746-87 (1999), Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
Change in processes affected
19
ASTM F961-03, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035)
Withdrawn and replaced with newer version
79
21
ASTM F1088-04, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Withdrawn and replaced with newer version
80
33
ASTM F1609-03, Standard Specification for Calcium Phosphate for Coatings for Implantable Materials
Withdrawn and replaced with newer version
81
34
ASTM F1659-95, Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates
Change in processes affected
35
ASTM F1713-03, Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications
Withdrawn and replaced with newer version
82
40
ASTM F2063-00, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants
Change in extent of recognition, contact person, and processes affected
42
ASTM F2119-01, Standard Test Method for Evaluation of MR Image Artifacts From Passive Implants
Change in processes affected
48
ASTM F899-02, Standard Specification for Stainless Steel for Surgical Instruments
Change in processes affected
70
ASTM F2052-02, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
Withdrawn
72
ASTM F2213-04, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Change in processes affected
Ortho #91
ASTM F561-97 (2003), Practice for Retrieval and Analysis of Implanted Medical Devices and Associated Tissues
Transferred to materials
73
Ortho #93
ASTM 601-03, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
Transferred to materials
94
Ortho #107
ASTM F1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coating
Transferred to materials
84
Ortho/PM #113
Dental # 22
ASTM F1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Transferred to materials
74
Ortho #124
ASTM F86-01, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Transferred to materials
93
Ortho #131
ASTM F1044-99, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Transferred to materials
83
Ortho #152
ASTM F1160-00e1, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
Transferred to materials
75
Ortho #160
ASTM F629-02, Standard Practice for Radiography of Cast Metallic Surgical Implants
Transferred to materials
95
G. OB-GYN/Gastroenterology
16
AAMI/ANSI ID54: 1996 (R)2001, Enteral Feeding Set Adapters and Connectors
Withdrawn and replaced with newer version
31
H. Orthopaedic
58
ASTM F1781-03, Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants
Withdrawn and replaced with newer version
168
91
ASTM F561-97, Practice for Retrieval and Analysis of Implanted Medical Devices and Associated Tissues
Transferred to materials
73
93
ASTM F601-98, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
Transferred to materials
94
107
ASTM F1147-99, Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
Transferred to materials
84
111
ASTM F1814-97a (2003), Standard Guide for Evaluating Modular Hip and Knee Joint Components
Withdrawn and replaced with newer version
171
113
ASTM F1377-98a, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Transferred to materials
74
114
ASTM F1798-97 (2003), Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
Withdrawn and replaced with newer version
172
115
ASTM F1800-97 (2003), Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Withdrawn and replaced with newer version
173
120
ASTM F382-99 (2003), Standard Specification and Test Method for Metallic Bone Plates
Withdrawn and replaced with newer version
174
124
ASTM F86-01, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Transferred to materials
93
131
ASTM F1044-99, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Transferred to materials
83
140
ASTM F1582-98 (2003), Standard Terminology Relating to Spinal Implants
Withdrawn and replaced with newer version
175
145
ASTM F565-00 (2003), Standard Practice for Care and Handling of Orthopedic Implants and Instruments
Withdrawn and replaced with newer version
176
152
ASTM F1160-00e1, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
Transferred to materials
75
160
ASTM F629-02, Standard Practice for Radiography of Cast Metallic Surgical Implants
Transferred to materials
95
161
ASTM F1264-03, Standard Specification and Test Methods for Intramedullary Fixation Devices
Withdrawn and replaced with newer version
177
165
ISO 7206-4: 2002, Implants for Surgery—Partial and Total Hip Joint Prostheses—Part 4: Determination of Endurance Properties of Stemmed Femoral Components
Withdrawn
I. Physical Medicine
1
ANSI/RESNA WC/volume—1998, Section 1: Determination of Static Stability
Withdrawn and replaced with newer version
31
2
ANSI/RESNA WC/volume 2—1998, Section 2: Determination of Dynamic Stability of Electric Wheelchairs
Withdrawn and replaced with newer version
32
3
ANSI/RESNA WC/volume 2—1998, Section 3: Test Methods and Requirements for the Effectiveness of Brakes
Withdrawn and replaced with newer version
33
4
ANSI/RESNA WC/volume 2—1998, Section 4: Determination of Energy Consumption of Electric Wheelchairs and Scooters—Theoretical Range
Withdrawn and replaced with newer version
34
5
ANSI/RESNA WC/volume 1—1998, Section 5: Determination of Overall Dimensions, Mass, and Turning Space
Withdrawn and replaced with newer version
35
6
ANSI/RESNA WC/volume 2—1998, Section 6: Determination of Maximum Speed, Acceleration, and Retardation of Electric Wheelchairs
Withdrawn and replaced with newer version
36
7
ANSI/RESNA WC/volume 1—1998, Section 7: Method of Measurement of Seating and Wheel Dimensions
Withdrawn and replaced with newer version
37
8
ANSI/RESNA WC/volume 1—1998, Section 8: Requirements and Test Methods for Static, Impact, and Fatigue Strengths
Withdrawn and replaced with newer version
38
9
ANSI/RESNA WC/volume 2—1998, Section 9: Climatic Tests for Electric Wheelchairs
Withdrawn and replaced with newer version
39
10
ANSI/RESNA WC/volume 2—1998, Section 10: Determination of Obstacle-Climbing Ability of Electric Wheelchairs
Withdrawn and replaced with newer version
40
11
ANSI/RESNA WC/volume 1—1998, Section 11: Test Dummies
Withdrawn and replaced with newer version
41
12
ANSI/RESNA WC/volume 1—1998, Section 13: Determination of Coefficient of Friction of Test Surfaces
Withdrawn and replaced with newer version
42
13
ANSI/RESNA WC/volume 2—1998, Section 14: Power and Control Systems for Electric Wheelchairs—Requirements and Test Methods
Withdrawn and replaced with newer version
43
14
ANSI/RESNA WC/volume 1—1998, Section 15: Requirements for Information Disclosure, Documentation, and Labeling
Withdrawn and replaced with newer version
44
15
ANSI/RESNA WC/volume 1—1998, Section 16: Resistance to Ignition of Upholstered Parts—Requirements and Test Methods
Withdrawn and replaced with newer version
45
18
ISO 7176-3: 2003, Wheelchairs—Part 3: Determination of Effectiveness of Brakes
Withdrawn and replaced with newer version
50
J. Radiology
39
IEC 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
71
NEMA UD 2-2004, Revision 3: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
Withdrawn and replaced with newer version
105
72
NEMA UD 3-2004, Revision 2: Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
Withdrawn and replaced with newer version
100
78
NEMA PS 3, Set: Digital Imaging and Communications in Medicine (DICOM) Set
Withdrawn and replaced with newer version
119
86
IEC 60601-2-33 (2002-05), Medical Electrical Equipment—Part 2-33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis
Withdrawn and replaced with newer version
104
88
IEC 60601-2-17 (2004-01), Medical Electrical Equipment—Part 2-17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading Equipment
Withdrawn and replaced with newer version
118
94
IEC 60731 Amendment 1 (2002-06), Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in Radiotherapy
Withdrawn and replaced with newer version
98
K. Sterility
16
ANSI/AAMI ST35: 2003, Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
Withdrawn and replaced with newer version
117
17
ANSI/AAMI ST44: 1992, BIER/EO Gas Vessels
Withdrawn
18
ANSI/AAMI ST45: 1992, BIER/Steam Vessels
Withdrawn
20
ANSI/AAMI ST50: 2004, Dry Heat (Heated Air) Sterilizers
Withdrawn and replaced with newer version
118
21
ANSI/AAMI ST55: 2003, Table-Top Steam Sterilizers
Withdrawn and replaced with newer version
119
48
ANSI/AAMI ST40: 1992/(R)1998, Table-Top Dry Heat (Heated Air) Sterilizers and Sterility Assurance in Dental and Medical Facilities
Change in relevant guidance and contact person
50
ANSI/AAMI ST42: 1998, Steam Sterilization and Sterility Assurance Using Table-Top Sterilizers in Office-Based, Ambulatory-Care Medical, Surgical, and Dental Facilities
Contact person
52
ANSI/AAMI ST59: 1999, Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements
Change in relevant guidance
53
ANSI/AAMI ST66: 1999, Sterilization of Health Care Products—Chemical Indicators—Part 2: Class 2 Indicators for Air Removal Test Sheets and Packs
Contact person
56
ASTM D3078: 2002, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
Withdrawn and replaced with newer version
120
57
ASTM D4169: 2004, Standard Practice for Performance Testing of Shipping Containers and Systems
Withdrawn and replaced with newer version
121
58
ASTM F88: 2000, Standard Test Method for Seal Strength of Flexible Barrier Materials
Withdrawn and replaced with newer version
122
63
ASTM F1886: 1998 (2004), Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
Reaffirmation
64
ASTM F1929: 1998 (2004), Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Reaffirmation
72
ANSI/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 Facilities
Contact person
74
ANSI/AAMI ST60: 1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements
Contact person
75
ANSI/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
Change in title, relevant guidance, and contact person
91
ASTM F2096: 2004, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test)
Withdrawn and replaced with newer version
123
103
AAMI/ANSI/ISO 11607: 2000, Packaging for Terminally Sterilized Medical Devices
Change in relevant guidance
105
ANSI/AAMI ST46: 2002, Steam Sterilization and Sterility Assurance in Health Care Facilities
Contact person
106
USP 27: 2004, Biological Indicator for Dry Heat Sterilization, Paper Carrier
Withdrawn and replaced with newer version
124
107
USP 27: 2004, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
Withdrawn and replaced with newer version
125
108
USP 27: 2004, Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer version
126
109
USP 27: 2004, <61> Microbial Limits Test
Withdrawn and replaced with newer version
127
110
USP 27: 2004, <71> Microbiological Tests, Sterility Tests
Withdrawn and replaced with newer version
128
111
USP 27: 2004, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL)
Withdrawn and replaced with newer version
129
112
USP 27: 2004, <151> Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer version
130
113
USP 27: 2004, <1211> Sterilization and Sterility Assurance of Compendial Articles
Withdrawn and replaced with newer version
131
114
USP 27: 2004, <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer version
132
115
USP 27: 2004, Biological Indicator for Steam Sterilization—Self-Contained
Withdrawn and replaced with newer version
133
116
ANSI/AAMI ST72: 2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing
Change 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 Standard
Reference No. and Date
A. Anesthesia
58
Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
ASTM G175-03
B. Dental/ENT
121
Dentistry—Dental Units—Part 2: Water and Air Supply
ISO 7494-2: 2003
C. General Hospital/General Plastic Surgery
112
Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilitates
ANSI/AAMI PB70: 2003
113
Standard Specification for Performance of Materials Used in Medical Face Masks
ASTM F2100-04
D. Materials
85
Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
ASTM F1854-01
86
Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings
ASTM F1926-03
87
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the TaberT Abraser
ASTM F1978-00e1
88
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
ASTM F2024-00
89
Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications
ASTM F1873-98
90
Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
ASTM F2255-03
91
Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
ASTM F2256-03
92
Standard Test Method for Strength Properties of Tissue Adhesives in Tension
ASTM F2258-03
96
Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
ASTM 1635-95 (2000)
97
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
ASTM F2129-04
98
Standard Specification for Acrylic Bone Cement
ASTM F451-99ae1
99
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis
ASTM F2004-03
100
Standard Terminology for Nickel-Titanium Shape Memory Alloys
ASTM F2005-00
101
Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
ASTM F2118-03
102
Standard Test Method for Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery
ASTM F2082-03
E. OB-GYN/Gastroenterology
30
Water Treatment Equipment for Hemodialysis Applications
ANSI/AAMI RD62: 2001
F. Ophthalmic
33
Contact Lens Care Products—Vocabulary, Performance Specifications, and Test Methodology
ANSI Z80.18
G. Orthopaedic
178
Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components Without Torsion
ASTM F1440-92 (2002)
179
Standard Specification for Femoral Prostheses—Metallic Implants
ASTM F2068-03
H. Physical Medicine
46
Determination of Performance of Stand-Up Type Wheelchairs
ANSI/RESNA WC/volume 1—1998, section 20
47
Set Up Procedures
ANSI/RESNA WC/volume 1—1998, section 22
48
Maximum Overall Dimensions
ANSI/RESNA WC/volume 1—1998, section 93
49
Nomenclature, Terms, and Definitions
ANSI/RESNA WC/volume 1—1998, section 0
I. Radiology
101
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—General Requirements
ANSI/ESNA RP-27.1.96
102
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Measurement Techniques
ANSI/ESNA RP-27.2.00
103
Recommended Practice for Photobiological Safety for Lamps and Lamp Systems—Risk Group Classification and Labeling
ANSI/ESNA RP-27.3.96
106
Optics and Optical Instruments—Lasers and Laser-Related Equipment—Lifetime of Lasers
ISO 17526: 2003
107
Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam Widths, Divergence Angle, and Beam Propagation Factor
ISO 11146: 1999
108
Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of Optical Surfaces—Part 1: 1-on-1 Test
ISO 11254-1: 2000
109
Lasers and Laser-Related Equipment—Determination of Laser-Induced Damage Threshold of Optical Surfaces—Part 2: S-on-1 Test
ISO 11254-2: 2001
110
Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for Absorptance of Optical Laser Components (revision of ISO 11551: 1997)
ISO 11551: 2003
111
Optics 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
112
Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Beam Positional Stability (revision of ISO 11670: 1999)
ISO 11670: 2003
113
Lasers and Laser-Related Equipment—Test Methods for Laser Beam Parameters—Polarization (revision of ISO 12005: 1999)
ISO 12005: 2003
114
Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Methods for Laser Beam Power (Energy) Density Distribution
ISO 13694: 2000
115
Optics and Photonics—Lasers and Laser-Related Equipment—Test Methods for the Spectral Characteristics of Lasers
ISO 13695: 2004
116
Optics and Optical Instruments—Test Methods for Radiation Scattered by Optical Components
ISO 13696: 2002
117
Lasers and Laser-Related Equipment—Test Methods for Determination of the Shape of a Laser Beam Wavefront—Part 1: Terminology and Fundamental Aspects
ISO 15367-1: 2003
120
Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography
IEC 60601-2-44 (ed. 2.1)
J. Sterility
134
Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators
ANSI/AAMI ST44: 2002
135
Sterilization of Health Care Products—Requirements for the Development, Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry Heat
ANSI/AAMI ST63: 2002
136
Sterilization of Health Care Products—Requirements for Products Labeled “Sterile”
ANSI/AAMI ST67: 2003
137
Sterilization of Health Care Products—Vocabulary
ANSI/AAMI/ISO TIR 11139: 2002
138
Aseptic Processing of Health Care Products—Part 2: Filtration
ISO 13408-2: 2003
139
Cleanrooms and Associated Controlled Environments—Part 1: Classification of Air Cleanliness
ISO 14644-1: 1999
140
Cleanrooms and Associated Controlled Environments—Part 2: Specifications for Testing and Monitoring to Prove Continued Compliance With ISO 14644-1
ISO 14644-2: 2000
141
Cleanrooms and Associated Controlled Environments—Part 4: Design, Construction, and Start-Up
ISO 14644-4: 2001
142
Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 1: General Principles and Methods
ISO 14698-1: 2003
143
Cleanrooms and Associated Controlled Environments—Biocontamination Control—Part 2: Evaluation and Interpretation of Biocontamination Data
ISO 14698-2: 2003
K. Tissue Engineering
5
Standard Guide for Characterization and Testing of Hyaluronan as Starting Material Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
ASTM 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
.
Dated: September 21, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-22183 Filed 10-1-04; 8:45 am]
BILLING CODE 4160-01-S
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.