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Food and Drug Administration Modernization Act of 1997; Modifications to the List of Recognized Standards, Recognition List Number: 012

A Notice by the Food and Drug Administration on 05/27/2005

Published Document: 05-10626 (70 FR 30756)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. 2004N-0226]

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: 012” (Recognition List Number: 012), 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: 012” 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: . 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: 012 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.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards, developed by international and national organizations, for use in satisfying portions of device premarket review submissions or other requirements.

In a notice published in the Federal Register of February 25, 1998 (63 FR 9561), FDA announced the availability of a guidance entitled “Recognition and Use of Consensus Standards.” The notice described how FDA will implement its standard recognition program and provided the initial list of FDA recognized consensus standards.

In Federal Register notices published on October 16, 1998 (63 FR 55617), July 12, 1999 (64 FR 37546), November 15, 2000 (65 FR 69022), May 7, 2001 (66 FR 23032), January 14, 2002 (67 FR 1774), October 2, 2002 (67 FR 61893), April 28, 2003 (68 FR 22391), March 8, 2004 (69 FR 10712), 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 described the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language” (HTML) and “portable document format” (PDF) versions of the list of FDA recognized consensus standards. Both versions are publicly accessible at the agency's Internet site at http://www.fda.gov/​cdrh/​stdsprog.html. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.

II. Modifications to Recognition List Number: 012

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: 012” 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
3 ASTM F1161-88, Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas Machines Contact person  
4 ASTM F1242-96, Standard Specification for Cuffed and Uncuffed Tracheal Tubes Withdrawn  
7 ASTM F1627-95, Standard Specification for Pediatric Tracheostomy Tubes Withdrawn  
( printed page 30757)
9 IEC 60601-2-12 (2001-10), Medical Electrical Equipment—Part 2-12: Particular Requirements for the Safety of Lung Ventilators—Critical Care Ventilators Withdrawn and replaced with newer version 60
15 ISO 5361-4: 1987, Tracheal Tubes—Part 4: Cole Type Contact person  
18 ISO 8359: 1996, Oxygen Concentrators for Medical Use—Safety Requirements Contact person  
19 ISO 8382: 1988, Resuscitators Intended for Use With Humans Contact person  
20 ISO 9703-1: 1992, Anesthesia and Respiratory Care Alarm Signals—Part 1: Visual Alarm Signals Withdrawn  
21 ISO 9703-2: 1994, Anesthesia and Respiratory Care Alarm Signals—Part 2: Auditory Alarm Signals Withdrawn  
30 IEC 60601-2-13 (2003-05), Medical Electrical Equipment—Part 2-13: Particular Requirements for the Safety and Essential Performance of Anesthetic Systems Withdrawn and replaced with newer version 61
31 ISO 5356-1: 2004, Anaesthetic and Respiratory Equipment—Conical Connectors—Part 1: Cones and Sockets Withdrawn and replaced with newer version 62
35 ISO 5361: 1999, Anaesthetic and Respiratory Equipment—Tracheal Tubes and Connectors Contact person  
38 CGA V-1: 2003, Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections Withdrawn and replaced with newer version 63
42 ISO 5360: 1993, Anaesthetic Vaporizers—Agent Specific Filling Systems Contact person  
44 ISO 5366-1: 2000, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 1: Tubes and Connectors for Use in Adults Contact person and type of standard  
50 ASTM F920-93 (1999), Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans Contact person  
52 ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care Contact person  
53 ASTM F1464-93 (1999), Standard Specification for Oxygen Concentrators for Domiciliary Use Contact person  
54 ASME PVHO-1-2002-2003, Safety Standard for Pressure Vessels for Human Occupancy Withdrawn and replaced with newer version 64
55 ASTM F1054-01, Standard Specification for Conical Fittings Contact person  
57 ASTM F1101-90 (2003)e1, Standard Specification for Ventilators Intended for Use During Anesthesia Contact person  
59 ASTM F1456-01, Standard Specification for Minimum Performance and Safety Requirements for Capnometers Contact person  
B. Cardiovascular/Neurology
3 AAMI NS28: 1988/(R)1993, Intracranial Pressure Monitoring Contact person  
18 IEC 60601-2-27 (1994), Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Electrocardiographic Monitoring Equipment Contact person and processes affected  
43 ANSI/AAMI EC38: 1998, Ambulatory Electrocardiographs Contact person, processes affected and extent of recognition  
C. Dental/Ear, Nose, and Throat
61 ISO 1562: 1993, Dental Casting Gold Alloys Contact person  
116 ISO 10139-1: 1991, Dentistry—Resilient Lining Materials for Removable Dentures—Part 1: Short-Term Materials Date of standard  
D. General Hospital/General Plastic Surgery
( printed page 30758)
1 AAMI BF7: (R2002), Blood Transfusion Micro-Filters Withdrawn and replaced with newer version 119
29 IEC 60601-2-19 1996-10, “Amendment 1”—Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby Incubators Title  
32 IEC 60601-2-20 1996-10, “Amendment 1”—Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Transport Incubators Title  
37 ASTM F1054-01, Standard Specification for Conical Fittings Withdrawn and replaced with newer version 120
63 ISO 8536-7-1999, Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations for Infusion Bottles Title  
65 ISO 8536-2-2001, Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles Withdrawn and replaced with newer version 121
67 ISO 8536-5-2004, Infusion Equipment for Medical Use—Part 5: Burette Type Infusion Sets for Single Use, Gravity Feed Withdrawn and replaced with newer version 122
71 ASTM E667-03, Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers Withdrawn and replaced with newer version 123
73 ASTM E1104-03, Standard Specification for Clinical Thermometer Probe Covers and Sheaths Withdrawn and replaced with newer version 124
74 ASTM E1965-03, Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature Withdrawn and replaced with newer version 125
75 ISO 8536-4-2004, Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed Withdrawn and replaced with newer version 126
76 ISO 1135-4-2004, Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use Withdrawn and replaced with newer version 127
78 ASTM F1670-03, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood Withdrawn and replaced with newer version 128
79 ISO 594/2-1998, Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment—Part 2: Lock Fittings Withdrawn and replaced with newer version 129
E. Materials
36 ASTM F1801-97 (2004), Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials Withdrawn and replaced with newer version 103
51 ASTM F1108-04, Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) Withdrawn and replaced with newer version 104
69 Title: ISO 5832-10: 1996, Implants for Surgery—Metallic Materials—Part 10: Wrought Titanium 5-Aluminum 2,5-Iron Withdrawn  
70 Title: ASTM F2052-02, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment Error in October 4, 2004 Federal Register Notice (69 FR 59240) (Recognition List Number: 011) [Docket No. 2004N-0226]—not withdrawn 70
96 ASTM F1635-04(a), Standard Test Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants Withdrawn and replaced with newer version 105
F. Ophthalmic
5 ISO 9363-1: 1994, Optics and Optical Instruments—Contact Lenses—Determination of Cytotoxicity of Contact Lens Material—Part 1: Agar Overlay Test and Growth Inhibition Test Withdrawn  
( printed page 30759)
14 ANSI Z80.20-2004, Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical Properties Withdrawn and replaced with newer version 34
15 ISO 9394:1998, Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Biocompatibility by Ocular Study Using Rabbit Eyes Title  
30 ANSI Z80.7-2002, Ophthalmics—Intraocular Lenses Title  
G. Radiology
1 ANSI PH 2.43-1982, Method for Sensitometry/Medical X-Ray Screen-Film Title  
5 ANSI PH 2.50-1983, Method/Sensitometry Direct-Exposure Medical/Dental Title  
7 IEC/ISO 10918-1: 1994, Information Technology—Digital Compression and Coding of Continuous-Tone Still Images—Part 1: Requirements and Guidelines Title  
8 IEC 60336 (R1993), X-Ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal Spots Title and standards development organization  
14 NEMA MS 5-2003, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging Withdrawn and replaced with newer version 125
22 IEC NEMA XR5-1992 (R1999), Measurement of Dimensions and Properties of Focal Spots of Diagnostic X-Ray Tubes Withdrawn  
23 NEMA XR 10-1986 (R1992, R1998), Measurement of the Maximum Symmetrical Radiation Field From a Rotating Anode X-Ray Tube Used for Medical Diagnosis Contact person, title, and standards development organization  
33 IEC 60601-2-1: 1998, Medical Electrical Equipment—Part 2: Particular Requirements for Medical Electron Accelerators in the Range 1 MeV to 50 MeV Withdrawn  
36 IEC 60601-2-9 (1996-10), Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Patient Contact Dosimeters Used in Radiotherapy With Electrically Connected Radiation Detectors—ed. 2.0 Title  
40 IEC 60601-2-28: 2003, 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 Withdrawn and replaced with newer version 126
42 IEC 60601-2-32: 2003, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Associated Equipment of X-Ray Equipment—ed. 1.0 Withdrawn and replaced with newer version 127
50 IEEE N42.13-1993, Calibration and Usage of “Dose Calibrator” Ionization Chambers for the Assay of Radionuclides Withdrawn and replaced with newer version 128
52 UL 544 (1998), Standard for Medical and Dental Equipment—ed. 4.0 Title  
58 ANSI N43.6-1997, Sealed Radioactive Sources, Classification Title and standards development organization  
61 UL 122 (1999), Standard for Photographic Equipment—ed. 4.0 Title  
62 UL 187 (1998), Standard for X-Ray Equipment—ed. 7.0 Title  
74 NEMA MS 7-1998, Measurement Procedure for Time-Varying Gradient Fields (dB/dt) for Magnetic Resonance Imaging Systems Withdrawn  
75 NEMA NU 1-2004, Performance Measurements of Scintillation Cameras Withdrawn and replaced with newer version 129
83 IEC 60601-2-37 2004, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment Consolidated, ed. 1.1 Withdrawn and replaced with newer version 130
87 IEC 61217 2003, Radiotherapy Equipment—Coordinates, Movements and Scales Consolidated, ed. 1.1 Withdrawn and replaced with newer version 131
( printed page 30760)
90 IEC 60601-2-1 (1998-06), Medical Electrical Equipment—Part 2-1: Particular Requirements for the Safety of Electron Accelerators in the Range 1 MeV to 50 MeV Title  
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 10 kV to 1 MV Title  
98 IEC 60731 (2002-06), Amendment 1—Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in Radiotherapy Withdrawn and replaced with newer version 132
120 IEC 60601-2-44 (2002-11), Medical Electrical Equipment—Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography—ed. 2.1 Title  
H. Sterility
121 ASTM D4169-04a, Standard Practice for Performance Testing of Shipping Containers and Systems Extent of recognition  
123 ASTM F2096-04, Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test) Title  
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 Title  

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: 012, follows:

Table 2.
Item No. Title of Standard Reference No. and Date
A. General Hospital/General Plastic Surgery
114 Pen-Injectors for Medical Use—Part 1: Pen-Injectors—Requirements and Test Methods ISO 11608-1: 2000
115 Pen-Injectors for Medical Use—Part 2: Needles—Requirements and Test Methods ISO 11608-2: 2000
116 Pen-Injectors for Medical Use—Part 3: Finished Cartridges—Requirements and Test Methods ISO 11608-3: 2000
117 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers ASTM F2172-02
118 Standard Specification for Circulating Liquid and Forced Air Patient Temperature Management Devices ASTM F2196-02
B. Radiology
121 Ultrasonics—Surgical Systems—Measurement and Declaration of the Basic Output Characteristics, ed. 1.0 IEC 61847: 1998
122 Medical Electrical Equipment—Requirements for the Safety of Radiotherapy Treatment Planning Systems, ed. 1.0 IEC 62083: 2000
123 Ultrasonics—Physiotherapy Systems—Performance Requirements and Methods of Measurement in the Frequency Range 0.5 MHz to 5 MHz, ed. 1.0 IEC 61689: 1996
C. Sterility
144 Standard Test Method for Linear Measurement Using Precision Steel Rule ASTM F2203-02 e1
145 Standard Practice for Coating/Adhesive Weight Determination ASTM F2217-02
146 Standard Test Method of Leaks in Non-Sealed and Empty Medical Packaging Trays by CO2 Tracer Gas Method ASTM F2227-02
147 Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas Method ASTM F2228-02
( printed page 30761)
148 Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials ASTM F2250-03
149 Standard Test Method for Thickness Measurement of Flexible Packaging Materials ASTM F2251-03 e1
150 Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape ASTM F2252-03
151 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method ASTM F2338-04

IV. List of Recognized Standards

FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm.

FDA will incorporate the modifications and minor revisions described in this document into the database and, upon publication in the Federal Register , this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT ). To be properly considered, such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

In order to receive “Guidance on the Recognition and Use of Consensus Standards” via your fax machine, call the Center for Devices and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 321 followed by the pound sign. Follow the remaining voice prompts to complete your request.

You may also obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register , this document announcing “Modification to the List of Recognized Standards, Recognition List Number: 012” will be available on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/​cdrh.

You may access “Guidance on the Recognition and Use of Consensus Standards,” and the searchable database for FDA recognized consensus standards through the hyperlink at http://www.fda.gov/​cdrh/​stdsprog.html.

This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/​cdrh/​fedregin.html.

VII. Submission of Comments and Effective Date

Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT ) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 012. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register .

Dated: May 16, 2005.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

[FR Doc. 05-10626 Filed 5-26-05; 8:45 am]

BILLING CODE 4160-01-S

Published Document: 05-10626 (70 FR 30756)