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Notice

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019

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Information about this document as published in the Federal Register.

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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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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: 019” (Recognition List Number: 019), 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: 019” 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.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: 019 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, 2098 Gaither Rd., Rockville, MD 20850, 240-276-0533.

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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 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)
September 12, 2007 (72 FR 52142)

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup Start Printed Page 71925language (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: 019

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: 019 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.StandardChangeReplacement Item No.
A. Anesthesia
11IEC 60601-3-1:1996-08 Medical Electrical Equipment - Part 3-1: Essential Performance Requirement for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring EquipmentTitle Change Contact person
18ISO 8359:1996 Oxygen Concentrators for Medical Use - Safety RequirementsContact person
51ASTM F1100-90(1997) Standard Specification for Ventilators Intended for Use in Critical CareContact person Relevant guidance
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 CapnometersRelevant guidance
60IEC 60601-2-12:(2001-10) Medical Electrical Equipment - Part 2-12: Particular Requirements for the Safety of Lung Ventilators - Critical Care VentilatorsContact person Relevant guidance
61IEC 60601-2-13(2003-05):, Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsRelevant guidance
65ISO 21647: 2004 Medical Electrical Equipment - Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas MonitorsTitle Change Relevant guidance
69ASTM F1464-93(2005) Standard Specification for Oxygen Concentrators for Domiciliary UseContact person
70ASTM F 1246-91 (2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator CircuitsContact person Relevant guidance
71ISO 10651-5:2006 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-powered Emergency ResuscitatorsContact person
B. General
20ASTM F1140:1988: Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical ApplicationsWithdrawn
C. General Hospital/General Plastic Surgery
21ISO 10555-3: 1996 Sterile, Single-use Intravascular Catheters - Part 3: Central Venous CathetersWithdrawn duplicate171
81ASTM E1061-01(2007) Standard Specification for Direct-Reading Liquid Crystal Forehead ThermometersWithdrawn and replaced with newer version200
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111IEC 60601-2-38: 1996 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Electrically Operated Hospital BedsWithdrawn duplicate182
117ASTM F2172-02:, Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid WarmersContact person
121ISO 8536-2-2001 Infusion Equipment for Medical Use - Part 2: Closures for Infusion BottlesWithdrawn duplicate173
126ISO 8536-4:2007 Infusion Equipment for Medical Use -- Part 4: Infusion Sets for Single-use, Gravity FeedWithdrawn and replaced with newer version201
162ISO 8536-1:2000/Amendment 1:2004 Infusion Equipment for Medical Use - Part 1: Infusion Glass BottlesWithdrawn duplicate172
D. In Vitro Diagnostics
31CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second EditionWithdrawn and replaced with newer version130
E. Materials
3ASTM F90-07 Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)Withdrawn and replaced with newer version145
30ASTM F1537-07 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539)Withdrawn and replaced with newer version152
41ASTM F2066-07 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150)Withdrawn and replaced with newer version146
42ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive ImplantsWithdrawn and replaced with newer version153
45ASTM F562-07 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)Withdrawn and replaced with newer version147
48ASTM F899-07 Standard Specification for Stainless Steel for Surgical InstrumentsWithdrawn and replaced with newer version148
56ISO 5832-1:2007 Implants for Surgery -- Metallic Materials -- Part 1: Wrought Stainless SteelWithdrawn and replaced with newer version149
62ISO 5832-9:2007 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless SteelWithdrawn and replaced with newer version150
64ISO 5832-12:2007 Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloyWithdrawn and replaced with newer version151
F. OB-GYN/Gastroenterology
5IEC 60601-2-18 (1996) Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic EquipmentWithdrawn duplicate42
G. Ophthalmic
35ISO 10939:2007 Ophthalmic Instruments -- Slit-lamp MicroscopesContact person
37ISO 10942:2006 Ophthalmic Instruments -- Direct ophthalmoscopesContact person
38ISO 10943:2006 Ophthalmic Instruments -- Indirect ophthalmoscopesContact person
39ISO 12865:2006 Ophthalmic Instruments -- RetinoscopesContact person
51ISO 15004-2:2007 Ophthalmic Instruments—Fundamental Requirements and Test Methods Part 2: Light Hazard ProtectionContact person
H. Radiology
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7IEC / ISO 10918-1:1994 Information Technology--Digital Compression and Coding of Continuous-tone Still Images - Part 1: Requirements and GuidelinesWithdrawn duplicate150
76NU 2-2007 Performance Measurements of Positron Emission TomographsWithdrawn and replaced with newer version167
84IEC 60825-1 Ed. 2.0 (2007) Safety of Laser Products - Part 1: Equipment Classification and RequirementsWithdrawn and replaced with newer version168
85IEC 60601-2-22 Ed. 3.0 (2007) Medical Electrical Equipment - Part 2-22: Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser EquipmentWithdrawn and replaced with newer version169
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 MeVWithdrawn duplicate152
102ANSI / IESNA RP-27.2-2000 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement TechniquesContact person
103ANSI / IESNA RP-27.3-1996 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and LabelingContact person
112ISO 11670:2003 Lasers and Laser-related Equipment - Test Methods for Laser Beam Parameters - Beam Positional StabilityWithdrawn duplicate156
114ISO 13694:2000 Optics and Optical Instruments - Lasers and Laser-related Equipment - Test Methods for Laser Beam Power (energy) Density DistributionWithdrawn duplicate157
119NEMA PS 3.1 - 3.18 (2007) Digital Imaging and Communications in Medicine (DICOM) SetWithdrawn and replaced with newer version170
153ANSI / IESNA RP-27.1-2005 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General RequirementsContact person
I. Software/Informatics
4ANSI/UL 1998 Software in Programmable ComponentsRelevant guidance
5IEC 60601-3-1:1996-08 Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipmentRelevant guidance
8IEC 62304 Ed. 1.0 Medical device software - Software life cycle processesRelevant guidance
J. Sterility
25ANSI/AAMI/ISO 11135-1:2007 Sterilization of Health Care Products - Ethylene oxide - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical DevicesWithdrawn and replaced with newer version228
63ASTM F1886: 1998 (2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual InspectionRelevant guidance
64ASTM F1929:1998 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye PenetrationRelevant guidance
86ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesWithdrawn and replaced with newer version229
120ASTM D3078:2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble EmissionRelevant guidance
136AAMI/ANSI ST67:2003 Sterilization of Health Care Products - Requirements for Products Labeled 'Sterile' 1st editionRelevant guidance
144ASTM F2203-02(2007) Standard Test Method for Linear Measurement Using Precision Steel RuleWithdrawn and replaced with newer version230
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145ASTM F2217-02(2007) Standard Practice for Coating/Adhesive Weight DeterminationWithdrawn and replaced with newer version231
146ASTM F2227-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO2 Tracer Gas MethodWithdrawn and replaced with newer version232
147ASTM F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO2 Tracer Gas MethodWithdrawn and replaced with newer version233
167ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical ProductsWithdrawn and replaced with newer version234
168ASTM F2338-05 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay MethodRelevant guidance
169ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer GasRelevant guidance
170ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging MaterialsRelevant guidance
193AAMI/ANSI/ISO 11607-1:2006 Packaging for Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems, 3ed.Relevant guidance
194AAMI/ANSI/ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1ed.Relevant guidance
196ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained PackagesWithdrawn and replaced with newer version235
197ASTM F1608:00(2004) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)Relevant guidance
198ASTM F2054-07 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining PlatesWithdrawn and replaced with newer version236
199ASTM D4169-05 Standard Practice for Performance Testing of Shipping Containers and SystemsRelevant guidance
200ASTM F88-07 Standard Test Method for Seal Strength of Flexible Barrier MaterialsWithdrawn and replaced with newer version237
K. Tissue Engineering
2ASTM F2103-01(2007)e1 Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product ApplicationsWithdrawn and replaced with newer version12

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: 019.

Table 3.

Item No.Title of StandardReference No. & Date
A. Anesthesia
76Anaesthetic and Respiratory Equipment—User-applied Labels for Syringes Containing Drugs Used During Anaesthesia—Colours, Design and PerformanceISO 26825:2007
B. Dental/ ENT
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145Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical FileISO 22803:2004
146Dentistry—Metallic Materials for Fixed and Removable Restorations and AppliancesISO 22674: 2006
C. General Hospital/ General Plastic Surgery
202Lasers and Laser-related Equipment -- Test Method and Classification for the Laser-resistance of Surgical Drapes and/or Patient-protective Covers -- Part 2: Secondary IgnitionISO 11810-2:2007
D. Ophthalmic
53Ophthalmic optics—Contact Lenses -- Part 1: Vocabulary, Classification System and Recommendations for Labeling SpecificationsISO 18369-1:2006
54Ophthalmic Optics- Contact Lenses- Part 4: Physicochemical Properties of Contact Lens MaterialsISO 18369-4:2006
55Ophthalmic implants -- Intraocular Lenses -- Part 6: Shelf-life and Transport StabilityISO 11979-6:2007
E. Radiology
171Optics and Photonics -- Microlens Arrays -- Part 2: Test Methods for Wavefront AberrationsISO 14880-2:2006
172Optics and Photonics -- Microlens Arrays -- Part 3: Test Methods for Optical Properties Other than Wavefront AberrationsISO 14880-3:2006
173Optics and Photonics -- Microlens Arrays -- Part 4: Test Methods for Geometrical PropertiesISO 14880-4:2006
174Optics and Photonics -- Lasers and Laser-related Equipment -- Test Methods for Specular Reflectance and Regular Transmittance of Optical Laser ComponentsISO 13697:2006
175Optics and Photonics -- Lasers and Laser-related Equipment -- Measurement of Phase Retardation of Optical Components for Polarized Laser RadiationISO 24013:2006
176Evaluation and Routine Testing in Medical Imaging Departments - Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray EquipmentIEC 61223-3-2 Ed. 2.0 (2007)
F. Sterility
238Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal TestsANSI/AAMI/ISO11140-5:2007
239Aseptic Processing of Health Care Products—Part 3: LyophilizationISO 13408-3:2006
240Aseptic Processing of Health Care Products—Part 5: Sterilization-in-placeISO 13408-5:2006
241Aseptic Processing of Health Care Products—Part 6: Isolator SystemsISO 13408-6:2005
242Cleanrooms and Associated Controlled Environments—Part 3: Test MethodsISO 14644-3:2005
243Cleanrooms and Associated Controlled Environments—Part 6: VocabularyISO 14644-6:2007
244Cleanrooms and Associated Controlled Environments - Part 8: Classification of Airborne Molecular ContaminationISO 14644-8:2006

IV. List of Recognized Standards

FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Internet site at http://www.accessdata.fda.gov/​scripts/​cdrh/​cfdocs/​cfStandards/​search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (See FOR FURTHER INFORMATION CONTACT). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard; (2) any reference number and date; (3) name and address of the national or international standards development organization; (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply; and (5) a brief identification of the testing or performance or other characteristics of Start Printed Page 71930the 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. 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: 019” 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. 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: 019. These modifications to the list or recognized standards are effective upon publication of this notice in the Federal Register.

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Dated: December 13, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. E7-24580 Filed 12-18-07; 8:45 am]

BILLING CODE 4160-01-S