Source: https://www.federalregister.gov/documents/2003/04/28/03-10417/fda-modernization-act-of-1997-modifications-to-the-list-of-recognized-standards-recognition-list
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Federal Register :: FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 008
FDA Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 008
68 FR 22391
22391-22400 (10 pages)
Docket No. 03N-0077
03-10417
II. Modifications to the List of Recognized Standards, Recognition List Number: 008
H. General Hospital/ General Plastic Surgery
I. In Vitro Devices
IV. Listing of New Entries
C. In Vitro Devices
https://www.federalregister.gov/d/03-10417 https://www.federalregister.gov/d/03-10417
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: 008” (Recognition List Number: 008) will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Submit written requests for single copies on a 3.5” diskette of “Modification to the List of Recognized Standards, Recognition List Number: 008” to the Division of Small Manufacturers Assistance (DSMA), Center for Devices and Radiological Health (CDRH) (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 to recommend additional standards for recognition to the contact person (see FOR FURTHER INFORMATION CONTACT). Comments should be identified with the docket number found in brackets in the heading of this document. 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: 008 modifications and other standards related information.
Carol L. Herman, Center for Devices and Start Printed Page 22392Radiological Health (HFZ-84), Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.
In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of guidance entitled “Recognition and Use of Consensus Standards.” This notice described how FDA will 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), and October 2, 2002 (67 FR 61893), FDA modified its initial list of recognized standards. These notices described the addition, withdrawal, and revision of certain standards recognized by FDA.
The agency maintains “html” and “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.
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: 008” to identify: (1) Supplementary information sheets for standards added to the list for the first time, (2) standards added to replace withdrawn standards, (3) recognized standards for which minor revisions are made to clarify the application of the standards, and (4) standards withdrawn with no replacement.
In the following charts, FDA describes: (1) Modifications that involve 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 addition of certain recognized standards with revisions to the supplementary information sheets involving changes in significant applications of the standards.
12 ISO 5361:1999 Anaesthetic and respiratory equipment—Tracheal tubes and connectors. Withdrawn and replaced with newer version. 35
13 ISO 5361-2:1993 Tracheal Tubes—Part 2: Oro-tracheal and Naso-tracheal tubes of Magill Type (plain and cuffed). Withdrawn and integrated into another standard. (35)
14 ISO 5361-3:1984 Tracheal Tubes—Part 3: Murphy Type. Withdrawn and integrated into another standard. (35)
16 ISO 5361-5:1984 Tracheal Tubes—Part 5: Requirements and Methods of Test for Cuffs and Tubes. Withdrawn and integrated into another standard. (35)
17 ISO 5366-3:2001 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: Paediatric tracheostomy tubes. Withdrawn and replaced with newer version. 36
26 CGA C-9:1988 Edition: 3 Title: Standard Color Marking of Compressed Gas Containers Intended for Medical Use. Withdrawn and replaced with newer version. 37
27 CGA V-1:2001 Edition: 9 Title: Compressed Gas Association Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections. Withdrawn and replaced with newer version. 38
28 CGA V-5:2000 Edition: 4 Title: Diameter Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications). Withdrawn and replaced with newer version. 39
29 CGA V-7.1: 1997 Edition: 1 Title: Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases. Withdrawn and replaced with newer version. 40
22 NFPA 99 Standard for Health Care Facilities CHAPTER 19—Hyperbaric Facilities. Withdrawn and replaced with newer version. 41
7 ASTM F719-81(2002)e1, Standard Practice for Testing Biomaterials in Rabbits for Primary Skin Irritation. Withdrawn and replaced with newer version. 68
30 ASTM F720-81(2002)e1, Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test. Withdrawn and replaced with newer version. 69
32 ASTM F750-87(2002)e1, Standard Practice for Evaluating Material Extracts by Systemic Injection in the Mouse. Withdrawn and replaced with newer version. 70
46 ASTM F2079-02 Standard Test Methods for Measuring Recoil of Balloon-Expandable Stents. Recognize newer year date version. 49
48 ANSI/ADA Specification No. 16:1989, Dental Impression Paste Zinc Oxide—Eugenol Type. Correction in title (dash between oxide and eugenol).
64 ISO 3107:1988, Dental Zinc Oxide/Eugenol Cements and Zinc Oxide Non-Eugenol Cements. Correction in title (slash between oxide and eugenol).
66 ISO 4049:1988, Dentistry-Resin—Based Filling Materials. Correction in year date (1988 instead of 1998).
86 ANSI/ADA Specification No. 38:2000, Metal-Ceramic Systems. Correction in title (change to systems).
6 IEC 60601-1-2, (First Edition, 1993-04), Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility—Requirements and Tests. Re-recognize 6
28 IEC 60601-1-2, (Second Edition), Medical Electrical Equipment—Part 1: General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests. Extension of time period for the transition statement. 28
81 ASTM E1061 Title correction 81
30 NCCLS H15-A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition. Revision 71
45 NCCLS M11-A5, Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard—Fifth Edition. Revision 75
10 NCCLS M23-A2, Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline—Second Edition. Revision 78
1 NCCLS C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline—Second Edition. Revision 81
20 NCCLS C34-A2, Sweat Testing: Collection and Quantitative Analysis; Approved Guideline—Second Edition. Revision 82
5 NCCLS H18-A2, Procedures for the Handling and Processing of Blood Specimens; Approved Guideline. Withdraw 57
8 NCCLS M2-A7, Performance Standards for Antimicrobial Disk Susceptibility Tests—Sixth Edition; Approved Standard. Withdraw 55
28 NCCLS H11-A3, Procedure for the Collection of Arterial Blood Specimens; Approved Standard. Withdraw 58
44 NCCLS M7-A5, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria Tests for Bacteria That Grow Aerobically—Fourth Edition; Approved Standard. Withdraw 56
1 ASTM F67-00, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). Clarification to extent of recognition with regard to biocompatibility requirements.
2 ASTM F75-01, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075). Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements.
3 ASTM F90-01, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605). Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements.
4 ASTM F136-02, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Withdrawn and replaced with newer version. Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements. 44
5 ASTM F138-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673). Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements.
6 ASTM F139-00, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673). Clarification to extent of recognition with regard to biocompatibility requirements.
7 ASTM F560-98, Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400). Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements.
8 ASTM F562-02, Standard Specification for Wrought 35 Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy for Surgical Implant Applications (UNS R30035). Withdrawn and replaced with newer version. Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements. 45
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). Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements.
10 ASTM F603-00, Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application. Clarification to extent of recognition with regard to biocompatibility requirements.
11 ASTM F620-00, Standard Specification for Alpha Plus Beta Titanium Alloy Forgings for Surgical Implants. Clarification to extent of recognition with regard to biocompatibility requirements.
12 ASTM F621-02, Standard Specification for Stainless Steel Forgings for Surgical Implants. Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 46
13 ASTM F648-00, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants. Clarification to extent of recognition with regard to biocompatibility requirements.
14 ASTM F688-00, Standard Specification for Wrought Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Plate, Sheet, and Foil for Surgical Implants (UNS R30035). Clarification to extent of recognition with regard to biocompatibility requirements.
15 ASTM F745-00, Standard Specification for 18 Chromium-12.5 Nickel-2.5 Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical Implant Applications. Clarification to extent of recognition with regard to biocompatibility requirements.
17 ASTM F799-02, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539). Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 47
18 ASTM F899-02, Standard Specification for Stainless Steel for Surgical Instruments. Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 48
19 ASTM F961-96, Standard Specification for Cobalt-35 Nickel-20 Chromium-10 Molybdenum Alloy Forgings for Surgical Implants (UNS R30035). Cardiovascular contact person. Clarification to extent of recognition with regard to biocompatibility requirements.
20 ASTM F1058-02, Standard Specification for Wrought 40 Cobalt-20 Chromium-16 Iron-15 Nickel-7 Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS R30003 and UNS R30008). Withdrawn and replaced with newer version. Cardiovascular contact person change. Clarification to extent of recognition with regard to biocompatibility requirements. 49
21 ASTM F1088-87(1992)e1, Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation. Clarification to extent of recognition with regard to biocompatibility requirements.
22 ASTM F1091-02, Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605). Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 50
23 ASTM F1108-02, Standard Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants (UNS R56406). Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 51
24 ASTM F1185-88 (1993)e1, Standard Specification for Composition of Ceramic Hydroxylapatite for Surgical Implants. Discontinued by ASTM in 2002, no replacement. Withdrawn
25 ASTM F1295-01, Standard Specification for Wrought Titanium-6 Aluminum-7 Niobium Alloy for Surgical Implant Applications (UNS R56700). Clarification to extent of recognition with regard to biocompatibility requirements.
26 ASTM F1314-01, 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). Clarification to extent of recognition with regard to biocompatibility requirements.
27 ASTM F1341-99, Standard Specification for Unalloyed Titanium Wire UNS R50250, UNS R50400, UNS R50550, UNS R50700, for Surgical Implant Applications. Clarification to Extent of Recognition with regard to biocompatibility requirements.
28 ASTM F1350-02, Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673). Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 52
29 ASTM F1472-02, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium Alloy for Surgical Implant Applications (UNS R56400). Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 53
30 ASTM F1537-00, Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloy for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). Clarification to extent of recognition with regard to biocompatibility requirements.
31 ASTM F1580-01, Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants. Withdrawn and replaced with newer version. Clarification to extent of recognition with regard to biocompatibility requirements. 54
32 ASTM F1586-02, Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675). Clarification to extent of recognition with regard to biocompatibility requirements.
33 ASTM F1609-95, Standard Specification for Calcium Phosphate Coatings for Implantable Materials. Clarification to extent of recognition with regard to biocompatibility requirements.
57 ASTM F1717-01 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. Withdrawn and replaced with newer version. 159
98 ASTM F629-02 Standard Practice for Radiography of Cast Metallic Surgical Implants. Withdrawn and replaced with newer version. 160
153 ASTM F1264-01 Standard Specification and Test Methods for Intramedullary Fixation Devices. Withdrawn and replaced with newer version. 161
156 ASTM F564-02 Standard Specification and Test Methods for Metallic Bone Staples. Withdrawn and replaced with newer version. 162
157 ASTM F543-02 Standard Specification and Test Methods for Metallic Medical Bone Screws. Withdrawn and replaced with newer version. 163
158 ASTM F1541-02 Standard Specification and Test Methods for External Skeletal Fixation Devices. Withdrawn and replaced with newer version. 164
71 ANSI/AAMI ST8:2001, Hospital Steam Sterilizers Change in Title (Sterilizers instead of Sterilization).
77 ANSI/AAMI ST24:1999, Automatic General Purpose Ethylene Oxide Sterilizers and Ethylene Oxide Sterilant Sources Intended for Use in Health Care Facilities, 3rd. Edition. Change in title (add third edition)
91 ASTM F2096-02, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Test). Recognize newer year version (Should be 02 instead of 01).
The listing of new entries and consensus standards added as “Modifications to the List of Recognized Standards,” under Recognition List Number: 008, is as follows:
42 Anaesthetic vaporizers—Agent-specific filling systems ISO 5360:1993
43 Anaesthetic reservoir bags ISO 5362:2000
44 Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 1: Tubes and connectors for use in adults. ISO 5366-1:2000
30 Medical Electrical Equipment—Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility—Requirements and Tests. ANSI/AAMI/IEC 60601-1-2:2001
65 Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline. NCCLS EP5-A:1999
66 Preliminary Evaluation of Quantitative Clinical Laboratory Methods; Approved Guideline. NCCLS EP10-A:1998
67 Evaluation of Matrix Effects; Approved Guideline NCCLS EP14-A:2001
68 Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline—Second Edition. NCCLS GP19-A2:2001
69 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; Approved Standard—Fourth Edition. NCCLS H3-A4:1998
70 Procedures and Devices for the Collection of Diagnostic Blood Specimens by Skin Puncture; Approved Standard—Fourth Edition. NCCLS H4-A4:1999
72 Clinical Application of Flow Cytometry: Quality Assurance Immunophenotyping of Lymphocytes; Approved Guideline. NCCLS H42-A:1998
73 Clinical Evaluation of Immunoassays; Approved Guideline NCCLS I/LA21-A:2002
74 Protocols for Evaluating Dehydrated Mueller-Hinton Agar; Approved Standard. NCCLS M6-A:1996
76 Laboratory Diagnosis of Blood-Borne Parasitic Diseases; Approved Guideline. NCCLS M15-A:2000
77 Quality Assurance for Commerically Prepared Microbiological Culture Media—Second Edition; Approved Standard. NCCLS M22-A2:1996
79 Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline. NCCLS M28-A:1997
80 Molecular Diagnostic Methods for Genetic Diseases; Approved Guideline. NCCLS MM1-A:2000
83 Blood Gas and pH Analysis and Related Measurements; Approved Guideline. NCCLS C46-A:2001
84 Stability Testing of In Vitro Diagnostic Reagents EN 13640:2001
30 Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests. ANSI/AAMI/IEC 60601-1-2:2001
31 Symbols to be used with medical device labels, labeling and information to be supplied. ISO 15223:2000
32 Graphical symbols for use in the labeling of medical devices. EN 980:1996+A1:1999+A2:2001
55 Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging. ASTM F2182-02
1 Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Products Application. ASTM F2064:2000
2 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications. ASTM F2103:2001
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.
You may 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 this 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: 008” 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 data base for “FDA Recognized Consensus Standards,” through hyperlinks at http://www.fda.gov/​cdrh/​stdsprog.html. This Federal Register notice of modifications in FDA's recognition of consensus standards will be available, upon publication, at http://www.fda.gov/​cdrh/​fedregin.html.
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 copy. Identify comments 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: 008.” These modifications to the list of recognized standards are effective upon publication of this notice.
[FR Doc. 03-10417 Filed 4-25-03; 8:45 am]