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Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 016

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




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: 016” (Recognition List Number: 016), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.


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.


Submit written requests for single copies of “Modifications to the List of Recognized Standards, Recognition List Number: 016” to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Start Printed Page 64719Health (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 Web site at​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: 016 modifications and other standards related information.

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Carol L. Herman, Center for Devices and Radiological Health (HFZ-84), Food and Drug Administration, 12720 Twinbrook Pkwy., Rockville, MD 20857, 301-827-0021.

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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.

FDA has modified its initial list of recognized standards in the following Federal Register notices:

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)

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains “hypertext markup language” (HTML) and “portable document format” (PDF) versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the agency's Web 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: 016

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: 016” 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 2.

Old Item No.StandardChangeReplacement Item No.
A. Anesthesia
39CGA V-5: 2005, Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)Withdrawn and replaced with newer version68
53ASTM F1464-93 (2005), Standard Specification for Oxygen Concentrators for Domiciliary UseWithdrawn and replaced with newer version69
65ISO 21647: 2005, Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas MonitorsDevices affected, Code of Federal Regulations citation, and relevant guidance
B. Biocompatibility
107ASTM F1877-05, Standard Practice for Characterization of ParticlesWithdrawn and replaced with newer version114
108ASTM F1905-98 (2003), Standard Practice for Selecting Tests for Determining the Propensity of Materials for Cause ImmunotoxicityTitle
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C. Dental/Ear, Nose, and Throat (ENT)
49ANSI/ADA Specification No. 17: 1983 (R1999), Denture Base Temporary Relining ResinsWithdrawn and replaced with newer version130
64ISO 3107: 2004, Dental Zinc Oxide/Eugenol Cements and Zinc Oxide Non-Eugenol CementsWithdrawn and replaced with newer version131
66ISO 4049: 1988, Dentistry—Resin-Based Filling MaterialsWithdrawn. Refer to item no. 99
70ISO 6874: 2005, Dental Resin-Based Pit and Fissure SealantsWithdrawn and replaced with newer version132
71ISO 6876: 2001, Dental Root Canal Sealing MaterialsWithdrawn and replaced with newer version133
74ISO 7494-1: 2004, Dentistry—Dental Units—Part 1: General Requirements and Test MethodsWithdrawn and replaced with newer version134
114ANSI/ADA Specification No. 48: 1989, Visible Curing UnitsTitle
116ISO 10139-1: 2005, Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-Term UseWithdrawn and replaced with newer version135
D. General Hospital/General Plastic Surgery
83ASTM D6319-00a (2005), Standard Specification for Nitrile Examination Gloves for Medical ApplicationWithdrawn and replaced with newer version167
87ASTM D3577-06, Standard Specification for Rubber Surgical GlovesWithdrawn and replaced with newer version168
106ASTM D3772-01 (2005), Standard Specification for Natural Rubber Finger CotsWithdrawn and replaced with newer version169
E. In Vitro Diagnostics
003CLSI/NCCLS GP10-A 1995, Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved GuidelineContact person
004CLSI/NCCLS GP14-A 1996, Labeling of Home-Use In Vitro Testing Products; Approved GuidelineContact person
007CLSI/NCCLS LA1-A2 1994, Assessing the Quality of Radioimmunoassay Systems—2d ed.; Approved GuidelineContact person
012CLSI/NCCLS C12-A, Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved StandardContact person
013CLSI/NCCLS C21-A, Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved StandardContact person
015CLSI/NCCLS C25-A, Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved GuidelineContact person
016CLSI/NCCLS C27-A, Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved GuidelineContact person
018CLSI/NCCLS C30-A, Ancillary (Bedside) Blood Glucose TestingContact person
038CLSI/NCCLS I/LA10-A, Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved GuidelineContact person
039CLSI/NCCLS I/LA17-A, Assessing the Quality of Systems for Alpha-Fetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved GuidelineContact person
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043CLSI/NCCLS LA4-A3, Blood Collection on Filter Paper for Neonatal Screening Programs; Approved Standard—3d ed.Contact person
048CLSI/NCCLS T/DM6-A, Blood Alcohol Testing in the Clinical Laboratory; Approved GuidelineContact person
051CLSI/NCCLS GP 27-A, Using Proficiency Testing (PT) to Improve the Clinical Laboratory; Approved GuidelineContact person
052CLSI/NCCLS NRSCL 8-A, Terminology and Definitions for Use in National Committee for Clinical Laboratory Standards (NCCLS) Documents; Approved StandardContact person
055CLSI/NCCLS H18-A2, Procedures for the Handling and Processing of Blood Specimens; Approved GuidelineContact person
059CLSI/NCCLS AUTO2-A, Laboratory Automation: Bar Codes for Specimen Container Identification; Approved StandardContact person
F. Materials
40ASTM F2063-05, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical ImplantsWithdrawn and replaced with newer version122
48ASTM F899-02, Standard Specification for Stainless Steel for Surgical InstrumentsContact person
60ISO 5832-5: 2005, Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel AlloyWithdrawn and replaced with newer version123
65ISO 5834-2: 2006, Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded FormsWithdrawn and replaced with newer version127
67ISO 7153-1: 1991/Amd. 1: 1999, Surgical Instruments—Metallic Materials—Part 1: Stainless SteelContact person
70ASTM F2052-06e1, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance EnvironmentWithdrawn and replaced with newer version124
72ASTM F2213-06, Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance EnvironmentWithdrawn and replaced with newer version128
85ASTM F1854-01, Standard Test Method for Stereological Evaluation of Porous Coatings on Medical ImplantsContact person
86ASTM F1926-03, Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate CoatingsContact person
88ASTM F2024-00, Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite CoatingsContact person
89ASTM F1873-98, Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant ApplicationsContact person
94ASTM F601-03, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical ImplantsContact person
99ASTM F2004-05, Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal AnalysisWithdrawn and replaced with newer version125
103ASTM F1801-97 (2004), Standard Practice for Corrosion Fatigue Testing of Metallic Implant MaterialsContact person
106ASTM F648-04, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical ImplantsContact person
109ASTM F561-05a, Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and FluidsWithdrawn and replaced with newer version126
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111ASTM F1160-05, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic CoatingsContact person
112ASTM F1044-05, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic CoatingsContact person
113ASTM F1147-05, Standard Test Method for Tension Testing of Calcium Phosphate and Metal CoatingsContact person
117ASTM F86-04, Standard Practice for Surface Preparation and Marking of Metallic Surgical ImplantsContact person
G. Obstetrics-Gynecology (OB-GYN)/Gastroenterology
28ANSI/AAMI RD16: 1996/A1: 2002/(R)2005, HemodialyzersReaffirmation
29ANSI/AAMI RD17: 1994/A1: 2002/(R)2005, Hemodialyzer Blood TubingReaffirmation
31ANSI/AAMI ID54: 1996/(R)2005, Enteral Feeding Set Adapters and ConnectorsReaffirmation
H. Ophthalmic
20ISO 11979-1: 1999, Ophthalmic Implants—Intraocular Lenses—Part 1: VocabularyContact person
22ISO 11979-3: 1999, Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test MethodsContact person
32ISO 11990: 2003, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Determination of Laser Resistance of Tracheal Tube ShaftsWithdrawn and transferred to Radiology
I. Orthopedic/Physical Medicine
85ISO 14630: 2005, Non-Active Surgical Implants—General RequirementsWithdrawn and replaced with newer version194
141ASTM F1612-95 (2005), Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components With TorsionWithdrawn and replaced with newer version195
142ASTM F1672-95 (2005), Standard Specification for Resurfacing Patellar ProsthesisWithdrawn and replaced with newer version196
150ASTM F983-86 (2005), Standard Practice for Permanent Marking of Orthopaedic Implant ComponentsWithdrawn and replaced with newer version197
162ASTM F564-02 (2006), Standard Specification and Test Methods for Metallic Bone StaplesWithdrawn and replaced with newer version201
174ASTM F382-99 (2003) e1, Standard Specification and Test Method for Metallic Bone PlatesWithdrawn and replaced with newer version198
176ASTM F565-04, Standard Practice for Care and Handling of Orthopedic Implants and InstrumentsWithdrawn and replaced with newer version199
193ASTM F2083-06, Standard Specification for Total Knee ProsthesisWithdrawn and replaced with newer version200
J. Radiology
32 (Opthalmic)ISO 11990: 2003, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Determination of Laser Resistance of Tracheal Tube ShaftsTransferred from Ophthalmic, type of standard, and contact person144
92IEC 61674 (1997-10), Medical Electrical Cquipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-Ray Diagnostic ImagingWithdrawn and replaced145
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93IEC 61674 (2002), Amendment 1, Medical Electrical Equipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-Ray Diagnostic ImagingWithdrawn and replaced145
118IEC 60601-2-17 (2005), Medical Electrical Equipment—Part 2-17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading EquipmentWithdrawn and replaced with newer version146
135IEC 60601-2-5 (2005), Medical Electrical Equipment—Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment ed. 2.0Withdrawn and replaced with newer version147
8IEC 60336 (2005), Medical Electrical Equipment—X-Ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal SpotsWithdrawn and replaced with newer version149
K. Sterility
74ANSI/AAMI ST 60: 1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General RequirementsWithdrawn
103ISO 11607-2000, Packaging for Terminally Sterilized Medical DevicesWithdrawn

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: 016, follows:

Table 3.

Item No.Title of StandardReference No. and Date
A. Dental/ENT
136Standard Practice for Describing System Output of Implantable Middle Ear Hearing DevicesASTM F2504-05
B. General Hospital/General Plastic Surgery
160Sterile Single-Use Syringes, With or Without Needle, for InsulinISO 8537: 1991/Amendment 1: 2000
161Sterile, Single-Use Intravascular Catheters—Part 1: General RequirementsISO 10555-1: 1996/Amendment 1: 1999, Amendment 2: 2004
162Infusion Equipment for Medical Use—Part 1: Infusion Glass BottlesISO 8536-1: 2000/Amendment 1: 2004
163Stainless Steel Needle Tubing for the Manufacture of Medical DevicesISO 9626: 1991/Amendment 1: 2001
164Sterile, Single-Use Intravascular Catheters—Part 5: Over-Needle Peripheral CathetersISO 10555-5: 1996/Amendment 1: 1999, Corrigendum 1: 2002
165Standard Specification for Polychloroprene Examination Gloves for Medical ApplicationASTM D6977-04
166Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other SharpsASTM F2132-01
C. In Vitro Diagnostics
124Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved GuidelineCLSI/NCCLS I/LA24-A
125Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved GuidelineCLSI M28-A2, Vol. 25, No. 16
126Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic ActinomycetesCLSI M24-A, Vol. 23, No. 18
D. OB-GYN/Gastroenterology
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38Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with OpticsISO 8600-3: 1997/Amendment 1: 2003
39Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 5: Determination of Optical Resolution of Rigid Endoscopes with OpticsISO 8600-5: 2005
40Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 6: VocabularyISO 8600-6: 2005
E. Radiology
145Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or Semi-Conductor Detectors as Used in X-Ray Diagnostic ImagingIEC 61674 (1997), (2002), Amendment 1
148Medical Electrical Equipment—Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring EquipmentIEC 60601-2-37 (2005), Amendment 2
F. Software
8Medical Device Software—Software Life Cycle ProcessesIEC 62304 ed. 1.0 (2006)
G. Sterility
193Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems, 3d ed.ANSI/AAMI/ISO 11607-1: 2006
194Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes, 1st ed.ANSI/AAMI/ISO 11607-2: 2006
195Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements, 2d ed.ANSI/AAMI/ISO 11140-1: 2005

IV. List of Recognized Standards

FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA's Web site at​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 section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

You may obtain a copy of “Guidance on the Recognition and Use of Consensus Standards” by using the Internet. 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 “Modifications to the List of Recognized Standards, Recognition List Number: 016” will be available on the CDRH home page. You may access the CDRH home page at​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​cdrh/​stdsprog.html.

This Federal Register document on modifications in FDA's recognition of consensus standards is available at​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. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 016. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register.

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Dated: October 27, 2006.

Linda S. Kahan,

Deputy Director, Center for Devices and Radiological Health.

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[FR Doc. E6-18604 Filed 11-2-06; 8:45 am]