Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 013
Federal RegisterNov 8, 2005
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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: 013
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
database for the current list of FDA recognized consensus standards, including Recognition List Number: 013 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, 12720 Twinbrook Pkwy., MD 20857, 301-827-0021.
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.
Standard
Change
Replacement Item No.
A. Anesthesia
52
ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care
Withdrawn
B. Biocompatibility
1
ASTM E1262-88 (2003), Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
Withdrawn and replaced with newer version
83
2
ASTM E1263-97 (2003), Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
Withdrawn and replaced with newer version
84
3
ASTM E1280-97 (2003), Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
Withdrawn and replaced with newer version
85
19
AAMI/ANSI/ISO10993-10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization
Withdrawn and replaced with newer version
86
20
AAMI/ANSI/ISO10993-10: 2002(E), Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization—Maximization Sensitization Test
Withdrawn and replaced with newer version
87
21
AAMI/ANSI/ISO10993-11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity
Extent of Recognition and Relevant Guidance
28
AAMI/ANSI/ISO10993-12:2002(E), Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference Materials
Withdrawn and replaced with newer version
88
34
ASTM F749-98 (2002)e2, Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Withdrawn and replaced with newer version
89
37
ASTM E1397-91 (2003), Standard Practice for the In Vitro Rat Hepatocyte DNA Repair Assay
Withdrawn and replaced with newer version
90
38
ASTM E1398-91 (2003), Standard Practice for the In Vivo Rat Hepatocyte DNA Repair Assay
Withdrawn and replaced with newer version
91
39
ASTM F748-04, Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Withdrawn and replaced with newer version
92
40
ASTM F763-04, Standard Practice for Short-Term Screening of Implant Materials
Withdrawn and replaced with newer version
93
41
ASTM F981-04, Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Withdrawn and replaced with newer version
94
42
ASTM F1984-99 (2003), Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
Withdrawn and replaced with newer version
95
43
ASTM F1903-98 (2003), Standard Practice for Testing for Biological Responses to Particles In Vitro
Withdrawn and replaced with newer version
96
45
ASTM F1983-99 (2003), Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
Withdrawn and replaced with newer version
97
51
AAMI/ANSI/ISO10993-1: 2003(E), Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing
Withdrawn and replaced with newer version
98
52
ASTM F1904-98e1 (2003), Standard Practice for Testing for Biological Responses to Particles In Vivo
Withdrawn and replaced with newer version
99
53
ASTM E1372-95 (2003), Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats
Withdrawn and replaced with newer version
100
70
ASTM F750-87 (2002)e1, Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
Relevant guidance
74
USP 28-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact Test
Withdrawn and replaced with newer version
101
75
USP 28-NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution Test
Withdrawn and replaced with newer version
102
76
USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vivo Procedure—Preparation of Sample
Withdrawn and replaced with newer version
103
77
USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test
Withdrawn and replaced with newer version
104
78
USP 28-NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Systemic Injection Test
Withdrawn and replaced with newer version
105
79
ASTM F619-03, Standard Practice for Extraction of Medical Plastics
Withdrawn and replaced with newer version
106
80
ASTM F1877 (2003)e1, Standard Practice for Characterization of Particles
Withdrawn and replaced with newer version
107
81
ASTM F1905 (2003)e1, Standard Practice for Selecting Tests for Determining the Propensity of Materials to Cause Immunotoxicity
Withdrawn and replaced with newer version
108
B. Cardiovascular/Neurology
4
ANSI/AAMI SP10:2002—Manual, Electronic, or Automated Sphygmomanometers
Withdrawn and replaced with newer version
53
5
ANSI/AAMI/ISO 7198:1998/2001(R) 2004, Cardiovascular Implants—Tubular vascular prostheses
Withdrawn and replaced with newer version
54
14
ASTM F1830:05, Recommended Practice for Selection of Blood for In Vitro Hemolytic Evaluation of Blood Pumps
Withdrawn and replaced with newer version
55
15
ASTM F1841:05, Recommended Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
Withdrawn and replaced with newer version
56
48
ASTM F2129:04, Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices
Withdrawn and replaced with newer version
57
C. Dental/Ear, Nose, and Throat
29
IEC 60601-2-18:2000 Amendment 1, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Endoscopic Equipment
Withdrawn and replaced with newer version
122
40
ANSI/ASA S3.6-2004, Specification for Audiometers
Withdrawn and replaced with newer version
123
41
ANSI/ASA S3.22:2003, Specification of Hearing Aid Characteristics
Withdrawn and replaced with newer version
124
61
ISO 1562:2004, Dentistry—Casting gold alloys
Withdrawn and replaced with newer version
125
82
ISO 10477:2004, Dentistry—Polymer-based crown and bridge materials
Withdrawn and replaced with newer version
126
D. General
16
ASTM D903:1993, Test Methods for Peel or Stripping Strength of Adhesive Bonds
Contact person
28
IEC 60601-1-2, (Second Edition), Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests
Extent of recognition
30
AAMI/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
2
IEC 60601-1, Medical Electrical Equipment—Part 1: General Requirements for Safety
Withdrawn
4
IEC 60601-1, Medical Electrical Equipment—Part 1: General Requirements for Safety, 1988; Amendment 1, l991-11, Amendment 2, 1995-03
Contact person, devices affected and extent of recognition
E. General Hospital/General Plastic Surgery
18
ISO 8537:1991 Sterile Single-Use Syringes, With or Without Needle, for Insulin
Contact person
38
ASTM 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 version
130
48
ASTM D6499-03 Standard Test Method for the Immunological Measurement of Antigenic Protein in Natural Rubber and its Products
Withdrawn and replaced with newer version
131
31 Ophthalmic
89 Radiology
ISO 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 Penetration
Transferred from Ophthalmic and Radiology
132
97
USP 28: 2005 Nonabsorbable Surgical Suture
Withdrawn and replaced with newer version
133
98
USP 28<11>: 2005 Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with newer version
134
99
USP 28: 2005 Absorbable Surgical Suture
Withdrawn and replaced with newer version
135
100
USP 28<881>: 2005 Tensile Strength
Withdrawn and replaced with newer version
136
101
USP 28<861>: 2005 Sutures—Diameter
Withdrawn and replaced with newer version
137
102
USP 28<871>: 2005 Sutures Needle Attachment
Withdrawn and replaced with newer version
138
103
USP 28<11>: 2005 Sterile Water for Irrigation
Withdrawn and replaced with newer version
139
104
USP 28<11>: 2005 Heparin Lock Flush Solution
Withdrawn and replaced with newer version
140
105
USP 28<11>: 2005 Sodium Chloride Injection
Withdrawn and replaced with newer version
141
11
ISO 594-1:1986 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 1: General Requirements
Title and contact person
13
ISO 595-1:1986 Reusable All-Glass or Metal-and-Glass Syringes for Medical Use—Part 1: Dimensions
Title and contact person
14
ISO 595-2:1987 Reusable All-Glass or Metal-and-Glass Syringes for Medical Use—Part 2: Design, Performance Requirements and Tests
Title and contact person
15
ISO 7864:1993 Sterile Hypodermic Needles for Single Use
Contact person
16
ISO 7886-1:1993 Sterile Hypodermic Syringes for Single Use—Part 1: Syringes for Manual Use
Title and contact person
62
ISO 8536-6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion Bottles
Title and contact person
63
ISO 8536-7-1999: Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations for Infusion Bottles
Contact Person
64
ISO 8536-3-1999: Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion Bottles
Title and contact person
66
ISO 8536-1-2000: Infusion equipment for medical use—Part 1: Infusion glass bottles
Title and Contact Person
68
ISO 7886-2-1996: Sterile Hypodermic Syringes for Single Use—Part 2: Syringes for Use With Power-Driven Syringe Pumps
Title and contact person
;
69
ISO 9626-1991: Stainless Steel Needle Tubing for the Manufacture of Medical Devices
Title and contact person
70
ASTM E825-98 (2003) Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
Contact person
111
IEC 60601-2-38 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds
Contact person
119
AAMI BF7: (R2002) Blood Transfusion Micro-Filters
Contact person
120
ASTM F1054-01: Standard Specification for Conical Fittings
Contact person
121
ISO 8536-2-2001: Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles
Contact person
122
ISO 8536-5-2004: Infusion Equipment for Medical Use—Part 5: Burette Infusion Sets for Single Use, Gravity Feed
Title and contact person
126
ISO 8536-4-2004: Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed
Contact person
127
ISO 1135-4-2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use
Contact person
129
ISO 594-2:1998 Conical Fittings With a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment—Part 2: Lock Fittings
Contact person
F. In Vitro Diagnostic
65
CLSI EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline—Second Edition
Withdrawn and replaced with new version
110
54
CLSI D12-A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline
Product codes
G. Materials
9
ASTM 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
13
ASTM F648-04: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Withdrawn and replaced with newer version
106
16
ASTM F746-04: Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
Withdrawn and replaced with newer version
107
25
ASTM F1295-05: Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700)
Withdrawn and replaced with newer version
108
34
ASTM F1659-95: Standard Test Method for Bending and Shear Fatigue Testing of Calcium Phosphate Coatings on Solid Metallic Substrates
Withdrawn
72
ASTM F2213-04: Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment
Title
73
ASTM F561-05, Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
Withdrawn and replaced with newer version
109
74
ASTM F1377-04: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)
Withdrawn and replaced with newer version
110
75
ASTM F1160-05: Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings
Withdrawn and replaced with newer version
111
80
ASTM F1088-04a: Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation
Title
83
ASTM F1044-05: Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
Withdrawn and replaced with newer version
112
84
ASTM F1147-05: Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
Withdrawn and replaced with newer version
113
90
ASTM F2255-05: Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
Withdrawn and replaced with newer version
114
91
ASTM F2256-05: Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
Withdrawn and replaced with newer version
115
92
ASTM F2258-05: Standard Test Method for Strength Properties of Tissue Adhesives in Tension
Withdrawn and replaced with newer version
116
93
ASTM F86-04: Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants
Withdrawn and replaced with newer version
117
H. OB-GYN/Gastroenterology
1
AAMI RD5:1992: Hemodialysis systems
Withdrawn
17
ASTM D3492-03: Standard Specification for Rubber Contraceptives (Male Condoms)
Withdrawn and replaced with newer version
32
24
ASTM F623-99e1: Standard Performance Specification for Foley Catheter
Withdrawn and replaced with newer version
33
26
ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1
Withdrawn and replaced with newer version
34
27
ASTM D6324-99a (Reapproved 2004): Standard Test Methods for Male Condoms Made From Synthetic Materials
Withdrawn and replaced with newer version
35
I. Ophthalmic
31
ISO 11810:2002, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers
Withdrawn newer version recognized under General Hospital/ General Plastic Surgery
J. Orthopedic
126
ASTM F366-04: Standard Specification for Fixation Pins and Wires
Withdrawn and replaced with newer version
180
159
ASTM F1717-04: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
Withdrawn and replaced with newer version
181
173
ASTM F1800-04: Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements
Withdrawn and replaced with newer version
182
K. Radiology
1
ANSI PH 2.43-1982: Method for Sensitometry/Medical X-Ray Screen-Film
Contact person
2
ANSI IT 1.48-1997 Photography (Films)—Medical Hard Copy Imaging Film-Dimensions and Specifications
Title and contact person
5
ANSI PH 2.50-1983: Method/Sensitometry Direct Exposure Medical/Dental
Contact person
6
IEC 60806 (R1984) Determination of the Maximum Symmetrical Radiation Field From a Rotating Anode X-ray Tube for Medical Diagnosis
Title and contact person
8
IEC 60336 (R1993) Medical Electrical Equipment—X-ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal Spots
Title
23
NEMA XR 10-1986 (R2003) Measurement of the Maximum Symmetrical Radiation Field from a Rotating Anode X-Ray Tube Used for Medical Diagnosis
Reaffirmation
34
IEC 60601-2-7-1998 Medical Electrical Equipment—Part 2-7: Particular Requirements for the Safety of High-Voltage Generators of Diagnostic X-ray Generators
Tile and contact person
37
IEC 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 Version
133
52
UL 544 (1998): Standard for Medical and Dental Equipment—Ed. 4.0
Contact person
56
IEC 61674-1997 Medical Electrical Equipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-ray Diagnostic Imaging
Withdrawn
57
IEC 60731-1997 Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in Radiotherapy
Title and devices affected
61
UL 122 (1999): Standard for Photographic Equipment—Ed. 4.0
Contact person
62
UL 187 (1998): Standard for X-Ray Equipment—Ed. 7.0
Contact person
79
NEMA XR 7-1995 (R2000) High-Voltage X-Ray Cable Assemblies and Receptacles
Title and contact person
80
NEMA XR 9-1984 (R1994, R2000) Power Supply Guidelines for X-Ray Machines
Contact person
81
NEMA XR 13-1990 (R1995, R2000) Mechanical Safety Standard for Power Driven Motions of Electromedical Equipment
Contact person
82
NEMA XR 14-1990 (R1995, R2000) Recommended Practices for Load Bearing Mechanical Assemblies Used in Diagnostic Imaging
Contact Person
89
ISO 11810:2002 Optics and Optical Instruments—Lasers and Laser-Related Equipment—Test Method for the Laser-Resistance of Surgical Drapes and/or Patient-Protective Covers
Withdrawn Newer version recognized under General Hospital/General Plastic Surgery
107
ISO 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 Beams
Withdrawn and replaced with newer version
134
119
NEMA PS 3.1—3.18 Digital Imaging and Communications in Medicine (DICOM) Set
Title
126
IEC 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. 1.0
Title and contact person
127
IEC 60601-2-32-1994 Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment—Ed. 1.0
Title and contact person
129
NEMA NU 1-2001 (Errata 2004): Performance Measurements of Scintillation Cameras
Title
131
IEC 61217-2002 Radiotherapy Equipment—Coordinates Movements and Scales Consolidated Ed. 1.1
Title
132
IEC 60731-2002 Amendment 1—Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in Radiotherapy
Title and devices affected
L. Sterility
48
ANSI/AAMI ST40:2004, Table-Top Dry Heat (Heated Air) Sterilization and Sterility Assurance in Dental and Medical Facilities, 2ed
Withdrawn and replaced with newer version
152
52
ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators Part 1: General
Title, relevant guidance, and contact person
70
ANSI/AAMI/ISO 14161:2000, Sterilization of Health Care Products—Biological Indicators—Guidance for the Selection, Use, and Interpretation of Results, 2ed.
Contact Person
71
ANSI/AAMI ST8:2001, Hospital Steam Sterilizers
Contact Person
77
ANSI/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
116
ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing
Relevant guidance
117
ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings
Relevant guidance and contact person
119
ANSI/AAMI ST55:2003, Table-Top Steam Sterilizers, 2ed.
Correct title and contact person
124
USP 28:2005, Biological Indicator for Dry Heat Sterilization, Paper Carrier
Withdrawn and replaced with newer version
153
125
USP 28:2005, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
Withdrawn and replaced with newer version
154
126
USP 28:2005, Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer version
155
127
USP28:2005, <61> Microbial Limits Test
Withdrawn and replaced with newer version
156
128
USP 28:2005, <71>, Microbiological Tests, Sterility Tests
Withdrawn and replaced with newer version
157
129
USP28:2005, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL)
Withdrawn and replaced with newer version
158
130
USP28:2005 <151>, Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer version
159
131
USP28:2005 <1211>, Sterilization and Sterility Assurance of Compendial Articles
Withdrawn and replaced with newer version
160
132
USP28:2005 <161>, Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer version
161
133
USP 28:2005, Biological Indicator for Steam Sterilization—Self-Contained
Withdrawn and replaced with newer version
162
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 Standard
Reference No. and Date
A. Anesthesia
65
Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors
ISO 21647:2005
66
Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use
ISO 9919:2005
B. Dental/Ear, Nose, Throat
127
Root Canal Files, Type H (Hedstrom)
ANSI/ADA Specification No. 58:2004
128
Dentistry—Elastomeric Impression Materials
ISO/4823:2000 Technical Corrigendum 1:2004
129
Dentistry—Elastomeric Impression Materials
ANSI/ADA Specification No. 19:2000 Technical Corrigendum 1:2004
C. General
34
Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 Consolidated With Amendment 1:2004))
IEC 60601-1-2:2004
35
Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004)
AAMI/IEC 60601-1-2:2001
D. General Hospital/General Plastic Surgery
142
Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby Incubators
ANSI/AAMI II36:2004
143
Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport Incubators
ANSI/AAMI II51:2004
E. In Vitro Diagnostic
109
Laboratory Automation: Data Content for Specimen Identification; Approved Standard
CLSI AUTO7-A:2004
111
Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays; Approved Guideline—Fourth Edition
CLSI H21-A4:2003
112
Point-of-Care Monitoring of Anticoagulation Therapy; Approved Guideline
CLSI H49-A:2004
113
Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
CLSI I/LA23-A:2004
114
Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
CLSI LIS01-A:2003
115
Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard—Second Edition
CLSI LIS02-A2:2004
116
Standard Guide for Selection of a Clinical Laboratory Information Management System
CLSI LIS03-A:2003
117
Standard Guide for Documentation of Clinical Laboratory Computer Systems
CLSI LIS04-A:2003
118
Standard Specification for Transferring Clinical Observations Between Independent Computer Systems
CLSI LIS05-A:2003
119
Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
CLSI LIS06-A:2003
120
Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
CLSI LIS07-A:2003
121
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
CLSI LIS08-A:2003
122
Standard Guide for Coordination of Clinical Laboratory Services Within the Electronic Health Record Environment and Networked Architectures
CLSI LIS09-A:2003
123
Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine
CLSI MM9-A:2004
F. Materials
118
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ASTM F2503-05
G. OB-GYN/Gastroenterology
36
Mechanical contraceptives—Reusable Natural and Silicone Rubber Contraceptive Diaphragms—Requirements and Tests
ISO 8009:2004(E)
H. Radiology
135
Medical electrical equipment—Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment Ed. 2.0
IEC 60601-2-5:2000
I. Sterility
163
Sterilization of Medical Devices—Microbiological methods—Part 3: Guidance on Evaluation and Interpretation of Bioburden Data
ANSI/AAMI/ISO 11737-3:2004
164
Sterilization of Medical Devices—Information To Be Provided by the Manufacturer for the Processing of Resterilizable Medical Devices
ANSI/AAMI ST81:2004
165
Cleanrooms and Associated Controlled Environments—Part 5: Operations
ISO 14644-5:2004
166
Cleanrooms and Associated Controlled Environments—Part 7: Separative Devices (Clean Air Hoods, Gloveboxes, Isolators and Mini-Environments)
ISO 14644-7:2004
J. Tissue Engineering
6
Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue Engineered Medical Products
ASTM F2450-04
7
Standard Guide for Immobilization or Encapsulation of Living Cells or Tissue in Alginate Gels
ASTM 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
.
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
.
Dated: October 10, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22267 Filed 11-7-05; 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.