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Notice

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

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Information about this document as published in the Federal Register.

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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: 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: 012 modifications and other standards related information.

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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.

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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.StandardChangeReplacement Item No.
A. Anesthesia
3ASTM F1161-88, Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Anesthesia Gas MachinesContact person
4ASTM F1242-96, Standard Specification for Cuffed and Uncuffed Tracheal TubesWithdrawn
7ASTM F1627-95, Standard Specification for Pediatric Tracheostomy TubesWithdrawn
Start Printed Page 30757
9IEC 60601-2-12 (2001-10), Medical Electrical Equipment—Part 2-12: Particular Requirements for the Safety of Lung Ventilators—Critical Care VentilatorsWithdrawn and replaced with newer version60
15ISO 5361-4: 1987, Tracheal Tubes—Part 4: Cole TypeContact person
18ISO 8359: 1996, Oxygen Concentrators for Medical Use—Safety RequirementsContact person
19ISO 8382: 1988, Resuscitators Intended for Use With HumansContact person
20ISO 9703-1: 1992, Anesthesia and Respiratory Care Alarm Signals—Part 1: Visual Alarm SignalsWithdrawn
21ISO 9703-2: 1994, Anesthesia and Respiratory Care Alarm Signals—Part 2: Auditory Alarm SignalsWithdrawn
30IEC 60601-2-13 (2003-05), Medical Electrical Equipment—Part 2-13: Particular Requirements for the Safety and Essential Performance of Anesthetic SystemsWithdrawn and replaced with newer version61
31ISO 5356-1: 2004, Anaesthetic and Respiratory Equipment—Conical Connectors—Part 1: Cones and SocketsWithdrawn and replaced with newer version62
35ISO 5361: 1999, Anaesthetic and Respiratory Equipment—Tracheal Tubes and ConnectorsContact person
38CGA V-1: 2003, Standard for Compressed Gas Cylinder Valve Outlet and Inlet ConnectionsWithdrawn and replaced with newer version63
42ISO 5360: 1993, Anaesthetic Vaporizers—Agent Specific Filling SystemsContact person
44ISO 5366-1: 2000, Anaesthetic and Respiratory Equipment—Tracheostomy Tubes—Part 1: Tubes and Connectors for Use in AdultsContact person and type of standard
50ASTM F920-93 (1999), Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With HumansContact person
52ASTM F1463-93 (1999), Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory CareContact person
53ASTM F1464-93 (1999), Standard Specification for Oxygen Concentrators for Domiciliary UseContact person
54ASME PVHO-1-2002-2003, Safety Standard for Pressure Vessels for Human OccupancyWithdrawn and replaced with newer version64
55ASTM F1054-01, Standard Specification for Conical FittingsContact person
57ASTM F1101-90 (2003)e1, Standard Specification for Ventilators Intended for Use During AnesthesiaContact person
59ASTM F1456-01, Standard Specification for Minimum Performance and Safety Requirements for CapnometersContact person
B. Cardiovascular/Neurology
3AAMI NS28: 1988/(R)1993, Intracranial Pressure MonitoringContact person
18IEC 60601-2-27 (1994), Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Electrocardiographic Monitoring EquipmentContact person and processes affected
43ANSI/AAMI EC38: 1998, Ambulatory ElectrocardiographsContact person, processes affected and extent of recognition
C. Dental/Ear, Nose, and Throat
61ISO 1562: 1993, Dental Casting Gold AlloysContact person
116ISO 10139-1: 1991, Dentistry—Resilient Lining Materials for Removable Dentures—Part 1: Short-Term MaterialsDate of standard
D. General Hospital/General Plastic Surgery
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1AAMI BF7: (R2002), Blood Transfusion Micro-FiltersWithdrawn and replaced with newer version119
29IEC 60601-2-19 1996-10, “Amendment 1”—Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby IncubatorsTitle
32IEC 60601-2-20 1996-10, “Amendment 1”—Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Transport IncubatorsTitle
37ASTM F1054-01, Standard Specification for Conical FittingsWithdrawn and replaced with newer version120
63ISO 8536-7-1999, Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations for Infusion BottlesTitle
65ISO 8536-2-2001, Infusion Equipment for Medical Use—Part 2: Closures for Infusion BottlesWithdrawn and replaced with newer version121
67ISO 8536-5-2004, Infusion Equipment for Medical Use—Part 5: Burette Type Infusion Sets for Single Use, Gravity FeedWithdrawn and replaced with newer version122
71ASTM E667-03, Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical ThermometersWithdrawn and replaced with newer version123
73ASTM E1104-03, Standard Specification for Clinical Thermometer Probe Covers and SheathsWithdrawn and replaced with newer version124
74ASTM E1965-03, Standard Specification for Infrared Thermometers for Intermittent Determination of Patient TemperatureWithdrawn and replaced with newer version125
75ISO 8536-4-2004, Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity FeedWithdrawn and replaced with newer version126
76ISO 1135-4-2004, Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single UseWithdrawn and replaced with newer version127
78ASTM F1670-03, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodWithdrawn and replaced with newer version128
79ISO 594/2-1998, Conical Fittings With a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment—Part 2: Lock FittingsWithdrawn and replaced with newer version129
E. Materials
36ASTM F1801-97 (2004), Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsWithdrawn and replaced with newer version103
51ASTM F1108-04, Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)Withdrawn and replaced with newer version104
69Title: ISO 5832-10: 1996, Implants for Surgery—Metallic Materials—Part 10: Wrought Titanium 5-Aluminum 2,5-IronWithdrawn
70Title: ASTM F2052-02, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentError in October 4, 2004 Federal Register Notice (69 FR 59240) (Recognition List Number: 011) [Docket No. 2004N-0226]—not withdrawn70
96ASTM F1635-04(a), Standard Test Method for In Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical ImplantsWithdrawn and replaced with newer version105
F. Ophthalmic
5ISO 9363-1: 1994, Optics and Optical Instruments—Contact Lenses—Determination of Cytotoxicity of Contact Lens Material—Part 1: Agar Overlay Test and Growth Inhibition TestWithdrawn
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14ANSI Z80.20-2004, Ophthalmics—Contact Lenses—Standard Terminology, Tolerances, Measurements and Physicochemical PropertiesWithdrawn and replaced with newer version34
15ISO 9394:1998, Ophthalmic Optics—Contact Lenses and Contact Lens Care Products—Determination of Biocompatibility by Ocular Study Using Rabbit EyesTitle
30ANSI Z80.7-2002, Ophthalmics—Intraocular LensesTitle
G. Radiology
1ANSI PH 2.43-1982, Method for Sensitometry/Medical X-Ray Screen-FilmTitle
5ANSI PH 2.50-1983, Method/Sensitometry Direct-Exposure Medical/DentalTitle
7IEC/ISO 10918-1: 1994, Information Technology—Digital Compression and Coding of Continuous-Tone Still Images—Part 1: Requirements and GuidelinesTitle
8IEC 60336 (R1993), X-Ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal SpotsTitle and standards development organization
14NEMA MS 5-2003, Determination of Slice Thickness in Diagnostic Magnetic Resonance ImagingWithdrawn and replaced with newer version125
22IEC NEMA XR5-1992 (R1999), Measurement of Dimensions and Properties of Focal Spots of Diagnostic X-Ray TubesWithdrawn
23NEMA XR 10-1986 (R1992, R1998), Measurement of the Maximum Symmetrical Radiation Field From a Rotating Anode X-Ray Tube Used for Medical DiagnosisContact person, title, and standards development organization
33IEC 60601-2-1: 1998, Medical Electrical Equipment—Part 2: Particular Requirements for Medical Electron Accelerators in the Range 1 MeV to 50 MeVWithdrawn
36IEC 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. 2.0Title
40IEC 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. 1.0Withdrawn and replaced with newer version126
42IEC 60601-2-32: 2003, Medical Electrical Equipment—Part 2: Particular Requirements for the Safety of Associated Equipment of X-Ray Equipment—ed. 1.0Withdrawn and replaced with newer version127
50IEEE N42.13-1993, Calibration and Usage of “Dose Calibrator” Ionization Chambers for the Assay of RadionuclidesWithdrawn and replaced with newer version128
52UL 544 (1998), Standard for Medical and Dental Equipment—ed. 4.0Title
58ANSI N43.6-1997, Sealed Radioactive Sources, ClassificationTitle and standards development organization
61UL 122 (1999), Standard for Photographic Equipment—ed. 4.0Title
62UL 187 (1998), Standard for X-Ray Equipment—ed. 7.0Title
74NEMA MS 7-1998, Measurement Procedure for Time-Varying Gradient Fields (dB/dt) for Magnetic Resonance Imaging SystemsWithdrawn
75NEMA NU 1-2004, Performance Measurements of Scintillation CamerasWithdrawn and replaced with newer version129
83IEC 60601-2-37 2004, Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment Consolidated, ed. 1.1Withdrawn and replaced with newer version130
87IEC 61217 2003, Radiotherapy Equipment—Coordinates, Movements and Scales Consolidated, ed. 1.1Withdrawn and replaced with newer version131
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90IEC 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 MeVTitle
91IEC 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 MVTitle
98IEC 60731 (2002-06), Amendment 1—Medical Electrical Equipment—Dosimeters With Ionization Chambers as Used in RadiotherapyWithdrawn and replaced with newer version132
120IEC 60601-2-44 (2002-11), Medical Electrical Equipment—Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography—ed. 2.1Title
H. Sterility
121ASTM D4169-04a, Standard Practice for Performance Testing of Shipping Containers and SystemsExtent of recognition
123ASTM F2096-04, Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)Title
135ANSI/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 HeatTitle

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

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Dated: May 16, 2005.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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

BILLING CODE 4160-01-S