Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 018
Federal RegisterSep 12, 2007
Ask Donna
What actually matters in this document.
Text
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: 018
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 018” (Recognition List Number: 018), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
DATES:
Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.
ADDRESSES:
Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 018” to the Division of Small Manufacturers,
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.hhs.gov
. This document may also be accessed on FDA's Web site at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm
. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 018 modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT:
Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0533.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.
In a notice published in the
Federal Register
of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards.
Modifications to the initial list of recognized standards, as published in the
Federal Register
, are identified in table 1 of this document.
Table 1.
Federal Register Cite
October 16, 1998 (63 FR 55617)
July 12, 1999 (64 FR 37546)
November 15, 2000 (65 FR 69022)
May 7, 2001 (66 FR 23032)
January 14, 2002 (67 FR 1774)
October 2, 2002 (67 FR 61893)
April 28, 2003 (68 FR 22391)
March 8, 2004 (69 FR 10712)
June 18, 2004 (69 FR 34176)
October 4, 2004 (69 FR 59240)
May 27, 2005 (70 FR 30756)
November 8, 2005 (70 FR 67713)
March 31, 2006 (71 FR 16313)
June 23, 2006 (71 FR 36121)
November 3, 2006 (71 FR 64718)
May 21, 2007 (72 FR 28500)
These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language” (HTML) and “portable document format” (PDF) versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.
II. Modifications to the List of Recognized Standards, Recognition List Number: 018
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency's searchable database. FDA will use the term “Recognition List Number: 018” to identify these current modifications.
In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA.
Table 2.
Old Item
No.
Standard
Change
Replacement
Item No.
A. Anesthesia
3
ASTM F1161-88, Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas Machines
Withdrawn
15
ISO 5361-4:1987, Tracheal Tubes—Part 4: Cole Type
Contact person
35
ISO 5361:1999, Anaesthetic and Respiratory Equipment—Tracheal Tubes and Connectors
Contact person
36
ISO 5366-3:2001, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 3: Pediatric Tracheostomy Tubes
Contact person
42
ISO 5360:2006, Anaesthetic Vaporizers—Agent Specific Filling Systems
Withdrawn and replaced with newer version
74
43
ISO 5362:2006, Anaesthetic Reservoir Bags
Withdrawn and replaced with newer version
75
44
ISO 5366-1:2000, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 1: Tubes and Connectors for Use in Adults
Contact person
46
ISO 5367:2000, Breathing Tubes Intended for Use With Anaesthetic Apparatus and Ventilators
Contact person
50
ASTM F920-93(1999): Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans
Withdrawn
55
ASTM F1054-01: Standard Specification for Conical Fittings
Withdrawn
61
IEC 60601-2-13(2003-05), Medical Electrical Equipment—Part 2-13: Particular Requirements for the Safety and Essential Performance of Anaesthetic Systems
Contact person
62
ISO 5356-1:2004, Anaesthetic and Respiratory Equipment—Conical Connectors: Part 1: Cones and Sockets
Contact person
B. Biocompatibility
21
AAMI / ANSI / ISO 10993-11:1993, Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity
Contact person
63
AAMI / ANSI / ISO 10993-6:1995/(R) 2001, Biological Evaluation of Medical Devices—Part 6: Test for Local Effects After Implantation
Contact person
64
AAMI / ANSI / ISO 10993-5:1999, Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity
Contact person
68
ASTM F719-81(2002)e1: Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation
Contact person
70
ASTM F750-87 (2002)e1: Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse
Contact person
71
ASTM F1408-02e1: Standard Practice for Subcutaneous Screening Test for Implant Materials
Contact person
83
ASTM E1262-88(2003): Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
Contact person
84
ASTM E1263-97(2003): Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes
Contact person
85
ASTM E1280-97 (2003): Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity
Contact person
87
AAMI / ANSI / ISO 10993-10:2002, Biological Evaluation of Medical Devices—Part 10: Tests for Irritation and Sensitization
Contact person
88
AAMI / ANSI / ISO 10993-12: 2002(E), Biological Evaluation of Medical Devices—Part 12: Sample Preparation and Reference materials
Contact person
89
ASTM F749-98 (2002)e2: Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
Contact person
90
ASTM E1397-91(2003): Standard Practice for the in vitro Rat Hepatocyte DNA Repair Assay
Contact person
91
ASTM E1398-91(2003): Standard Practice for the in vivo Rat Hepatocyte DNA Repair Assay
Contact person
92
ASTM F748-04: Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Contact person
93
ASTM F763-04: Standard Practice for Short-Term Screening of Implant Materials
Contact person
94
ASTM F981-04: Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Contact person
97
ASTM F1983-99(2003): Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
Contact person
98
AAMI / ANSI / ISO 10993-1:2003(E), Biological evaluation of medical devices—Part 1: Evaluation and Testing
Contact person
99
ASTM F1904-98(2003): Standard Practice for Testing the Biological Responses to Particles In Vivo
Contact person
100
ASTM E1372-95(2003): Standard Test Method for Conducting a 90-Day Oral Toxicity Study in Rats
Contact person
106
ASTM F619-03: Standard Practice for Extraction of Medical Plastics
Contact person
109
USP 29-NF21 Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact Test
Contact person
110
USP 29-NF21 Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution Test
Contact person
111
USP 29-NF21 Biological Tests <88>, Biological Reactivity Tests, In Vivo, Procedure—Preparation of Sample
Contact person
112
USP 29-NF21 Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Intracutaneous Test
Contact person
113
USP 29-NF21 Biological Tests <88>, Biological Reactivity Tests, In Vivo, Classification of Plastics—Systemic Injection Test
Contact person
114
ASTM F1877-05: Standard Practice for Characterization of Particles
Contact person
115
ASTM F895-84(2006): Standard Test Method for Agar Diffusion cell Culture Screening for Cytotoxicity
Contact person
116
ASTM F1439-03: Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
Contact person
C. General
2
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for safety
Withdrawn
11
ISO 2859-1:1999: Sampling Procedures for Inspection By Attributes—Part 1: Sampling Schemes Indexed by Acceptance Quality Limit (AQL)for Lot-by-Lot Inspection
Withdrawn and replaced with newer year version
37
14
ANSI/ASQ Z1.4-2003: Sampling Procedures and Tables for Inspection by Attributes
Withdrawn and replaced with newer year version
38
22
ISO 2768-1: 1989, General Tolerances—Part 1: Tolerances for Linear and Angular Dimensions Without Individual Tolerance Indications
Contact name
23
ISO 2768-2: 1989, General Tolerances—Part 2: Geometrical Tolerances for Features Without Individual Tolerance Indications
Contact name
24
IEC 60812, edition 2.0: 2006-01, Analysis Technique for System Reliability—Procedure for Failure Mode and Effects Analysis
Withdrawn and replaced with newer year version
39
26
ISO 14971:2007: Medical devices—Application of Risk Management to Medical Devices
Withdrawn and replaced with newer year version
40
28
IEC 60601-1-2, (Second Edition, 2001), Medical Electrical Equipment—Part 1-2: General Requirements for Safety; Electromagnetic Compatibility—Requirements and Tests
Extent of recognition
30
AAMI/ANSI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests. (The AAMI/ANSI/IEC 60601-1-2:2001 is the U.S. version of IEC 60601-1-2:2001 with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment.)
Title change
Type of standard
Extent of recognition
34
IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004; Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004))
Extent of recognition
35
AAMI/ANSI/IEC 60601-1-2, Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests (Edition 2:2001 with Amendment 1:2004) (AAMI/ANSI/IEC 60601-1-2:2001 is the U.S. version of IEC 60601-1-2:2001, with identical requirements for electromagnetic compatibility (EMC) of medical electrical equipment.)
Extent of recognition
D. General Hospital/ General Plastic Surgery
18
ISO 8537:1991 Sterile Single-use Syringes, With or Without Needle, for Insulin
Withdrawn duplicate
20
ISO 10555-1-1995 Sterile, Single-use Intravascular Catheters—Part 1: General Requirements
Withdrawn duplicate
46
IEC 60601-2-2 2006 Medical Electrical Equipment—Part 2-2: Particular Requirements for the Safety of High Frequency Surgical Equipment
Withdrawn and replaced with newer version
197
69
ISO 9626-1991: Stainless Steel Needle Tubing for the Manufacture of Medical Devices
Withdrawn duplicate
72
ISO 10555-5 1996-06-15 Sterile, Single-use Intravascular Catheters—Part 5: Over-needle Peripheral Catheters
Withdrawn duplicate
96
ASTM F2101-07 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus
Withdrawn and replaced with newer version
199
113
ASTM F2100-07 Standard Specification for Performance of Materials Used in Medical Face Masks
Withdrawn and replaced with newer version
198
108
ASTM F754-00 Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube and Rod Shapes
Transferred to materials
109
ASTM F881-94(2006) Standard Specification for Silicone Elastomer Facial Implants
Withdrawn and replaced with newer version
185
128
ASTM F1670-07 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
Withdrawn and replaced with newer version
186
130
ASTM F1671-07 Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
Withdrawn and replaced with newer version
187
151
USP 30:2007 Nonabsorbable Surgical Suture
Withdrawn and replaced with newer version
188
152
USP 30<11>: 2007 Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with newer version
189
153
USP 30:2007 Absorbable Surgical Suture
Withdrawn and replaced with newer version
190
154
USP 30<881>:2007 Tensile Strength
Withdrawn and replaced with newer version
191
155
USP 30<861>:2007 Sutures—Diameter
Withdrawn and replaced with newer version
192
156
USP 30<871>:2007 Sutures Needle Attachment
Withdrawn and replaced with newer version
193
157
USP 30<11>: 2007 Sterile Water for Irrigation
Withdrawn and replaced with newer version
194
158
USP 30<11>: 2007 Heparin Lock Flush Solution
Withdrawn and replaced with newer version
195
159
USP 30<11>: 2007 Sodium Chloride Injection
Withdrawn and replaced with newer version
196
181
ASTM F1862-07: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
Withdrawn and replaced with newer version
184
E. Materials
2
ASTM F75-07: Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075)
Withdrawn and replaced with newer year version
137
15
ASTM F745-07: Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications
Withdrawn and replaced with newer year version
138
26
ASTM F1314-07: Standard Specification for Wrought Nitrogen Strengthened 22 Chromium—13 Nickel—5 Manganese—2.5 Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910)
Withdrawn and replaced with newer year version
139
37
ASTM F1813-06: Standard Specification for Wrought Titanium—12 Molybdenum—6 Zirconium—2 Iron Alloy for Surgical Implant (UNS R58120)
Withdrawn and replaced with newer year version
140
43
ASTM F2146-07: Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320)
Withdrawn and replaced with newer year version
141
67
ISO 7153-1:1991/Amd. 1:1999, Surgical Instruments—Metallic Materials—Part 1: Stainless Steel
Contact person
87
ASTM F1978-00(2007)e2: Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser
Withdrawn and replaced with newer year version
142
89
ASTM F1873-98: Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications
Withdrawn
106
ASTM F648-07: Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Withdrawn and replaced with newer year version
143
128
ASTM F2213-06: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Title
GH/GPS 108
ASTM F754-00: Standard Specification for Implantable Polytetrafluoroethylene (PTFE) Polymer Fabricated in Sheet, Tube, and Rod Shapes
Transferred from GH/GPS to Materials
144
F. OB-GYN/Gastroenterology
20
ISO 8600-3:1997 Amendment 1 2003, Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with Optics
Withdraw duplicate
32
ASTM D3492-03 Standard Specification for Rubber Contraceptives (Male Condoms)
Extent of recognition, processes impacted, relevant guidance
33
ASTM F623-99(2006) Standard Performance Specification for Foley Catheter
Withdrawn and replaced with newer version
44
34
ISO 4074:2002/Cor.1:2003(E) Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1
Extent of recognition, relevant guidance
G. Ophthalmic
1
ISO 9338:1996 Optics and Optical Instruments—Contact Lenses—Determination of the Diameters
Withdrawn
2
ISO 9339-1:1996 Optics and Optical Instruments—Contact Lenses—Determination of the Thickness—Part 1: Rigid Contact Lenses
Withdrawn
4
ISO 9341:1996 Optics and Optical Instruments—Contact Lenses—Determination of Inclusions and Surface Imperfections for Rigid Contact Lenses
Withdrawn
7
ISO 9913-1:1996 Optics and Optical Instruments—Contact Lenses—Part 1: Determination of Oxygen Permeability and Transmissibility with the FATT Method
Withdrawn
8
ISO 10338:1996 Optics and Optical Instruments—Contact Lenses—Determination of Curvature
Withdrawn
9
ISO 10339:1997 Ophthalmic Optics—Contact Lenses—Determination of Water Content of Hydrogel Lenses
Withdrawn
10
ISO 10340:1995 Optics and Optical Instruments—Contact Lenses—Method for Determining the Extractable Substances
Withdrawn
11
ISO 10344:1996 Optics and Optical Instruments—Contact Lenses—Saline Solution for Contact Lens Testing
Withdrawn
16
ISO 9913-2:2000 Optics and Optical Instruments—Contact Lenses—Part 2: Determination of Oxygen Permeability and Transmissibility by the Coulometric Method
Withdrawn
17
ISO 10939:2007 Ophthalmic Instruments—Slit-lamp Microscopes
Withdrawn and replaced with newer version
35
19
ISO 11539:1999 Ophthalmic Optics—Contact Lenses—Classification of Contact Lenses and Contact Lens Materials
Withdrawn
22
ISO 11979-3:2006 Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test Methods
Withdrawn and replaced with newer version
36
25
ISO 12865:2006 Ophthalmic Instruments—Retinoscopes
Withdrawn and replaced with newer version
39
27
ISO 11979-7:2006 Ophthalmic Implants—Intraocular Lenses—Part 7: Clinical Investigations
Withdrawn and replaced with newer version
41
H. Orthopedic/ Physical Medicine
121
ISO 7207-1:1994, Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 1: Classification, Definitions and Designation of Dimensions
Withdrawn
I. Radiology
57 & 132
IEC 60731 (1997), (2002) Amendment 1, Medical Electrical Equipment—Dosimeters with Ionization Chambers as Used in Radiotherapy
Withdrawn and combine
162
59
IEC 61168:1993, Radiotherapy Simulators—Functional Performance Characteristics
Contact person
63
IEC 60601-2-43—Ed. 1.0, Medical Electrical Equipment—Part 2-43: Particular Requirements for the Safety of X-ray Equipment for Interventional Procedures
Contact person
91
IEC 60601-2-8 (1997-08), Amendment 1—Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Therapeutic X-ray Equipment Operating in the Range of 10 kV to 1 MV
Withdrawn duplicate
103
ANSI / IESNA RP-27.3-1996, Recommended Practice for Photobiological Safety for Lamps—Risk Group Classification and Labeling
Title
130 & 148
IEC 60601-2-37 (2004), (2005) Amendment 2, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
Withdrawn and combine
164
131
IEC 61217 2002:, Radiotherapy Equipment—Coordinates, Movements, and Scales Consolidated Ed. 1.1
Contact person
133
IEC 60601-2-11 (1997), (2004) Amendment 1, Medical Electrical Equipment—Part 2-11: Particular Requirements for the Safety of gamma Beam Therapy Equipment
Title
145
IEC 61674 (1997), (2002) Amendment 1, Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-conductor Detectors as Used in X-ray Diagnostic Imaging
Contact person
J. Sterility
28
ANSI/AAMI/ISO 11737-1:2006, Sterilization of Medical Devices—Microbiological Methods—Part 1: Determination of a Population of Microorganisms on Products, 2nd ed.
Withdrawn and replaced with newer version
227
47
ANSI/AAMI ST37:1996, Flash Sterilization: Steam Sterilization of Patient Care Items for Immediate Use
Withdrawn
49
ANSI/AAMI ST41:1999/(R) 2005, Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness
Reaffirmation
50
ANSI/AAMI ST42:1998, Steam Sterilization and Sterility Assurance Using Table-top Sterilizers in Office-based, Ambulatory-care Medical, Surgical, and Dental Facilities.
Withdrawn
52
ANSI/AAMI ST59:1999, Sterilization of Health Care Products—Biological Indicators—Part 1: General
Withdrawn
53
ANSI/AAMI ST66:1996, Sterilization of Health Care Products—Chemical Indicators—Part 2: Indicators for Air Removal Test Sheets and Packs
Contact person
54
ANSI/AAMI/ISO 11737-2:1998, Sterilization of Medical Devices—Microbiological Methods—Part 2: Tests of Sterility Performed in the Validation of a Sterilization Process
Contact person
60
ASTM F1327:1998, Standard Terminology Relating to Barrier Materials for Medical Packaging
Contact person
63
ASTM F1886: 1998 (2004), Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
Contact person
64
ASTM F1929:1998 (2004), Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Contact person
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
Withdrawn
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)
Withdrawn
77
ANSI/AAMI ST24:1999/(R) 2005, Automatic, General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for use in Health Care Facilities, 3rd ed.
Reaffirmation
86
ASTM F1980:2002, Standard Guide for Accelerated Aging of Sterile Medical Device Packages
Contact person
88
ANSI/AAMI/ISO 14937:2000, Sterilization of Health Care Products—General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices
Extent of recognition
90
ASTM F2095-01, Standard Test Methods for Pressure Decay Leak Test for Nonporous Flexible Packages With and Without Restraining Plates
Contact person
105
ANSI/AAMI ST46:2002, Steam Sterilization and Sterility Assurance in Health Care Facilities
Withdrawn
116
ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing
Contact person
117
ANSI/AAMI ST35:2003, Safe Handling and Biological Decontamination of Reusable Medical Devices in Health Care Facilities and in Nonclinical Settings
Extent of recognition
120
ASTM D3078:2002, Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
Contact person
123
ASTM F2096-04, Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
Contact person
134
ANSI/AAMI ST44:2002, Resistometers Used for Characterizing the Performance of Biological and Chemical Indicators
Withdrawn
135
ANSI/AAMI ST63:2002, Sterilization of Health Care Products—Requirements for the Development, Validation and Routine Control of an Industrial Sterilization Process for Medical Devices—Dry heat
Extent of recognition
136
ANSI/AAMI ST67:2003, Sterilization of Health Care Products—Requirements for Products Labeled ‘sterile’
Contact person
137
ANSI/AAMI/ISO TIR 11139:2006, Sterilization of Health Care Products—Vocabulary
Withdrawn and replaced with newer version
221
144
ASTM F2203-02e1, Standard Test Method for Linear Measurement Using Precision Steel Rule
Contact person
145
ASTM F2217-02, Standard Practice for Coating/Adhesive Weight Determination
Contact person
146
ASTM F2227-02, Standard Test Method of Leaks in Non-sealed and Empty Medical Packaging Trays by C02 Tracer Gas Method
Contact person
147
ASTM F2228-02, Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
Contact person
148
ASTM F2250-03, Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
Contact person
149
ASTM F2251-03e1, Standard Test Method for Thickness Measurement of Flexible Packaging Material
Contact person
150
ASTM F2252-03, Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
Contact person
163
ANSI/AAMI/ISO 11737-3:2004, Sterilization of Medical Devices—Microbiological Methods—Part 3: Guidance on Evaluation and Interpretation of Bioburden Data
Withdrawn
167
ASTM F2097-05, Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
Contact person
168
ASTM F2338-05, Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
Contact person
169
ASTM F2391-05, Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas
Contact person
170
ASTM F2475-05, Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Contact person
171
ANSI/AAMI/ISO 15882:2003, Chemical Indicators—Guidance on the Selection, Use, and Interpretation of Results
Contact person
172
AOAC 6.2.01:2006, Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
Withdrawn and replaced with newer version
211
173
AOAC 6.2.02:2006, Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
Withdrawn and replaced with newer version
212
174
AOAC 6.2.03:2006, Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
Withdrawn and replaced with newer version
213
175
AOAC 6.2.04:2006, Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus, Use-Dilution Method
Withdrawn and replaced with newer version
214
176
AOAC 6.2.05:2006, Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa, Hard Surface Carrier Test Method
Withdrawn and replaced with newer version
215
177
AOAC 6.2.06:2006, Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
Withdrawn and replaced with newer version
216
178
AOAC 6.3.02:2006, Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
Withdrawn and replaced with newer version
217
179
AOAC 6.3.05:2006, Official Method 966.04, Sporicidal Activity of Disinfectants, Method I
Withdrawn and replaced with newer version
218
180
AOAC 6.3.06:2006, Official Method 965.12, Tuberculocidal Activity of Disinfectants
Withdrawn and replaced with newer version
219
181
ANSI/AAMI ST58:2005, Chemical Sterilization and High-Level Disinfection in Health Care Facilities
Title, Devices affected and Relevant guidance
182
USP 30:2007, Biological Indicator for Dry-Heat Sterilization, Paper Carrier
Withdrawn and replaced with newer version
202
183
USP 30:2007, Biological Indicator for Ethylene Oxide Sterilization, Paper Carrier
Withdrawn and replaced with newer version
203
184
USP 30:2007, Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer version
204
185
USP 30:2007, <61> Microbial Limits Test
Withdrawn and replaced with newer version
205
186
USP 30:2007, <71> Microbiological Tests, Sterility Tests
Withdrawn and replaced with newer version
206
187
USP 30:2007, <85> Biological Tests and Assays, Bacterial Endotoxin Test (LAL)
Withdrawn and replaced with newer version
207
188
USP 30:2007, <151> Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer version
208
189
USP 30:2007, <161> Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer version
209
190
USP 30:2007, Biological Indicator for Steam Sterilization, Self-Contained
Withdrawn and replaced with newer version
210
193
ANSI/AAMI/ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3rd ed.
Contact person
194
ANSI/AAMI/ISO 11607-2:2006, Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1st ed.
Contact person
196
ASTM F1140-2005, Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
Contact person
197
ASTM F1608:2004, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
Contact person
198
ASTM F2054-05, Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
Contact person
199
ASTM D4169-05, Standard Practice for Performance Testing of Shipping Containers and Systems
Contact person
200
ASTM F88-2005, Standard Test Method for Seal Strength of Flexible Barrier Materials
Contact person
K. Tissue Engineering
3
ASTM F2212-02(2007)e1, Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
Withdrawn and replaced with newer version
11
III. Listing of New Entries
In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 018.
Table 3.
Item No.
Title of Standard
Reference No. and Date
A. Anesthesia
72
Lung Ventilators for Medical Use—Particular Requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators
ISO 10651-5:2006
73
Lung Ventilators—Part 4: Particular Requirements for Operator Powered Resuscitators
ISO 10651-4:2002
B. Biocompatibility
117
Biological Evaluation of Medical Devices—Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity
ANSI/AAMI/ISO 10993-3: 2003
C. Dental/ ENT
144
Dentistry-Mercury and Alloys for Dental Amalgam
ISO 24234: 2004(E)
D. OB-GYN/Gastroenterology
45
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
ASTM F2528-06
E. Ophthalmic
42
Ophthalmic Implants—Intraocular lenses—Part 2: Optical Properties and Test Methods
ISO 11979-2:1999/Corrigendum1:2003
43
Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Physical Compatibility of Contact Lens Care Products with Contact Lenses
ISO 11981:1999/ Corrigendum1:2005
45
Ophthalmic Optics—Contact Lenses—Part 2: Tolerances
ISO 18369-2:2006
46
Ophthalmic Optics—Contact Lenses—Part 3: Measurement Methods
ISO 18369-3:2006
48
Ophthalmic Implants—Intraocular Lenses—Part 5: Biocompatibility
ISO 11979-5:2006
49
Ophthalmic Implants—Intraocular Lenses—Part 9: Multifocal Intraocular Lenses
ISO 11979-9:2006
50
Ophthalmic implants—Intraocular lenses—Part 10: Phakic Intraocular Lenses
ISO 11979-10:2006
51
Ophthalmic Instruments—Fundamental Requirements and Test Methods Part 2: Light Hazard Protection
ISO 15004-2:2007
F. Radiology
165
“Quality Control Manual” Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
NEMA XR 22-2006
166
“Quality Control Manual” Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
NEMA XR 23-2006
G. Sterility
201
Containment Devices for Reusable Medical Device Sterilization
ANSI/AAMI ST77:2006
220
Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities
ANSI/AAMI ST79:2006
222
Sterilization of Health Care Products—Biological and Chemical Indicators—Test Equipment
ANSI/AAMI/ISO 18472:2006
223
Sterilization of Health Care Products—Biological Indicators—Part 1: General Requirements
ANSI/AAMI/ISO 11138-1:2006
224
Sterilization of Health Care Products—Radiation—Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices
ANSI/AAMI/ISO 11137-1:2006
225
Sterilization of Health Care Products—Radiation—Part 2: Establishing the Sterilization Dose
ANSI/AAMI/ISO 11137-2:2006
226
Sterilization of Health Care Products—Radiation—Part 3: Guidance on Dosimetric Aspects
ANSI/AAMI/ISO 11137-3:2006
H. Tissue Engineering
9
Standard Guide for Classification of Therapeutic Skin Substitutes
ASTM F2311-06
10
Standard Guide for
in vivo
Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
ASTM F2451-05
IV. List of Recognized Standards
FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Web site at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm
. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the
Federal Register
, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the
Federal Register
once a year, or more often, if necessary.
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (See
FOR FURTHER INFORMATION CONTACT
). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. The Center for Devices and Radiological Health (CDRH) maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the
Federal Register
, this notice announcing “Modification to the List of Recognized Standards, Recognition List Number: 018” will be available on the CDRH home page. You may access the CDRH home page at
http://www.fda.gov/cdrh
.
You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for “FDA Recognized Consensus Standards” through the hyperlink at
http://www.fda.gov/cdrh/stdsprog.html
.
This
Federal Register
document on modifications in FDA's recognition of consensus standards is available at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm
.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see
FOR FURTHER INFORMATION CONTACT
) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 018. These modifications to the list or recognized standards are effective upon publication of this notice in the
Federal Register
.
Dated: August 30, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-18021 Filed 9-11-07; 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.