# Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019 > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3AE7-24580 ## Record - **Collection:** Federal Register - **Document type:** Notice - **Published:** December 19, 2007 - **Citation:** 72 FR 71924 ## Text DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2004N-0226] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 019 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. 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. 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 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. 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. Standard Change Replacement Item No. A. Anesthesia 11 IEC 60601-3-1:1996-08 Medical Electrical Equipment - Part 3-1: Essential Performance Requirement for Transcutaneous Oxygen and Carbon Dioxide Partial Pressure Monitoring Equipment Title Change Contact person 18 ISO 8359:1996 Oxygen Concentrators for Medical Use - Safety Requirements Contact person 51 ASTM F1100-90(1997) Standard Specification for Ventilators Intended for Use in Critical Care Contact person Relevant guidance 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 Relevant guidance 60 IEC 60601-2-12:(2001-10) Medical Electrical Equipment - Part 2-12: Particular Requirements for the Safety of Lung Ventilators - Critical Care Ventilators Contact person Relevant guidance 61 IEC 60601-2-13(2003-05):, Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems Relevant guidance 65 ISO 21647: 2004 Medical Electrical Equipment - Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors Title Change Relevant guidance 69 ASTM F1464-93(2005) Standard Specification for Oxygen Concentrators for Domiciliary Use Contact person 70 ASTM F 1246-91 (2005) Standard Specification for Electrically Powered Home Care Ventilators, Part 1 - Positive-Pressure Ventilators and Ventilator Circuits Contact person Relevant guidance 71 ISO 10651-5:2006 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 5: Gas-powered Emergency Resuscitators Contact person B. General 20 ASTM F1140:1988: Standard Test Method for Failure Resistance of Unrestrained and Nonrigid Packages for Medical Applications Withdrawn C. General Hospital/General Plastic Surgery 21 ISO 10555-3: 1996 Sterile, Single-use Intravascular Catheters - Part 3: Central Venous Catheters Withdrawn duplicate 171 81 ASTM E1061-01(2007) Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers Withdrawn and replaced with newer version 200 111 IEC 60601-2-38: 1996 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Electrically Operated Hospital Beds Withdrawn duplicate 182 117 ASTM F2172-02:, Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers Contact person 121 ISO 8536-2-2001 Infusion Equipment for Medical Use - Part 2: Closures for Infusion Bottles Withdrawn duplicate 173 126 ISO 8536-4:2007 Infusion Equipment for Medical Use -- Part 4: Infusion Sets for Single-use, Gravity Feed Withdrawn and replaced with newer version 201 162 ISO 8536-1:2000/Amendment 1:2004 Infusion Equipment for Medical Use - Part 1: Infusion Glass Bottles Withdrawn duplicate 172 D. In Vitro Diagnostics 31 CLSI H20-A2 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition Withdrawn and replaced with newer version 130 E. Materials 3 ASTM 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 version 145 30 ASTM 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 version 152 41 ASTM F2066-07 Standard Specification for Wrought Titanium-15 Molybdenum Alloy for Surgical Implant Applications (UNS R58150) Withdrawn and replaced with newer version 146 42 ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants Withdrawn and replaced with newer version 153 45 ASTM F562-07 Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) Withdrawn and replaced with newer version 147 48 ASTM F899-07 Standard Specification for Stainless Steel for Surgical Instruments Withdrawn and replaced with newer version 148 56 ISO 5832-1:2007 Implants for Surgery -- Metallic Materials -- Part 1: Wrought Stainless Steel Withdrawn and replaced with newer version 149 62 ISO 5832-9:2007 Implants for Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel Withdrawn and replaced with newer version 150 64 ISO 5832-12:2007 Implants for surgery -- Metallic materials -- Part 12: Wrought cobalt-chromium-molybdenum alloy Withdrawn and replaced with newer version 151 F. OB-GYN/Gastroenterology 5 IEC 60601-2-18 (1996) Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment Withdrawn duplicate 42 G. Ophthalmic 35 ISO 10939:2007 Ophthalmic Instruments -- Slit-lamp Microscopes Contact person 37 ISO 10942:2006 Ophthalmic Instruments -- Direct ophthalmoscopes Contact person 38 ISO 10943:2006 Ophthalmic Instruments -- Indirect ophthalmoscopes Contact person 39 ISO 12865:2006 Ophthalmic Instruments -- Retinoscopes Contact person 51 ISO 15004-2:2007 Ophthalmic Instruments—Fundamental Requirements and Test Methods Part 2: Light Hazard Protection Contact person H. Radiology 7 IEC / ISO 10918-1:1994 Information Technology--Digital Compression and Coding of Continuous-tone Still Images - Part 1: Requirements and Guidelines Withdrawn duplicate 150 76 NU 2-2007 Performance Measurements of Positron Emission Tomographs Withdrawn and replaced with newer version 167 84 IEC 60825-1 Ed. 2.0 (2007) Safety of Laser Products - Part 1: Equipment Classification and Requirements Withdrawn and replaced with newer version 168 85 IEC 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 Equipment Withdrawn and replaced with newer version 169 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 Withdrawn duplicate 152 102 ANSI / IESNA RP-27.2-2000 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - Measurement Techniques Contact person 103 ANSI / IESNA RP-27.3-1996 Recommended Practice for Photobiological Safety for Lamps - Risk Group Classification and Labeling Contact person 112 ISO 11670:2003 Lasers and Laser-related Equipment - Test Methods for Laser Beam Parameters - Beam Positional Stability Withdrawn duplicate 156 114 ISO 13694:2000 Optics and Optical Instruments - Lasers and Laser-related Equipment - Test Methods for Laser Beam Power (energy) Density Distribution Withdrawn duplicate 157 119 NEMA PS 3.1 - 3.18 (2007) Digital Imaging and Communications in Medicine (DICOM) Set Withdrawn and replaced with newer version 170 153 ANSI / IESNA RP-27.1-2005 Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements Contact person I. Software/Informatics 4 ANSI/UL 1998 Software in Programmable Components Relevant guidance 5 IEC 60601-3-1:1996-08 Medical electrical equipment - Part 3-1: Essential performance requirement for transcutaneous oxygen and carbon dioxide partial pressure monitoring equipment Relevant guidance 8 IEC 62304 Ed. 1.0 Medical device software - Software life cycle processes Relevant guidance J. Sterility 25 ANSI/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 Devices Withdrawn and replaced with newer version 228 63 ASTM F1886: 1998 (2004) Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection Relevant guidance 64 ASTM F1929:1998 (2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration Relevant guidance 86 ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices Withdrawn and replaced with newer version 229 120 ASTM D3078:2002 Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission Relevant guidance 136 AAMI/ANSI ST67:2003 Sterilization of Health Care Products - Requirements for Products Labeled 'Sterile' 1st edition Relevant guidance 144 ASTM F2203-02(2007) Standard Test Method for Linear Measurement Using Precision Steel Rule Withdrawn and replaced with newer version 230 145 ASTM F2217-02(2007) Standard Practice for Coating/Adhesive Weight Determination Withdrawn and replaced with newer version 231 146 ASTM F2227-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Medical Packaging Trays by CO 2 Tracer Gas Method Withdrawn and replaced with newer version 232 147 ASTM F2228-02(2007) Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by CO 2 Tracer Gas Method Withdrawn and replaced with newer version 233 167 ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products Withdrawn and replaced with newer version 234 168 ASTM F2338-05 Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method Relevant guidance 169 ASTM F2391-05 Standard Test Method for Measuring Package and Seal Integrity Using Helium as Tracer Gas Relevant guidance 170 ASTM F2475-05 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials Relevant guidance 193 AAMI/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 194 AAMI/ANSI/ISO 11607-2:2006 Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes, 1ed. Relevant guidance 196 ASTM F1140-07 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages Withdrawn and replaced with newer version 235 197 ASTM F1608:00(2004) Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) Relevant guidance 198 ASTM F2054-07 Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates Withdrawn and replaced with newer version 236 199 ASTM D4169-05 Standard Practice for Performance Testing of Shipping Containers and Systems Relevant guidance 200 ASTM F88-07 Standard Test Method for Seal Strength of Flexible Barrier Materials Withdrawn and replaced with newer version 237 K. Tissue Engineering 2 ASTM 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 Applications Withdrawn and replaced with newer version 12 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 Standard Reference No. & Date A. Anesthesia 76 Anaesthetic and Respiratory Equipment—User-applied Labels for Syringes Containing Drugs Used During Anaesthesia—Colours, Design and Performance ISO 26825:2007 B. Dental/ ENT 145 Dentistry—Membrane Materials for Guided Tissue Regeneration in Oral and Maxillofacial Surgery—Contents of a Technical File ISO 22803:2004 146 Dentistry—Metallic Materials for Fixed and Removable Restorations and Appliances ISO 22674: 2006 C. General Hospital/ General Plastic Surgery 202 Lasers and Laser-related Equipment -- Test Method and Classification for the Laser-resistance of Surgical Drapes and/or Patient-protective Covers -- Part 2: Secondary Ignition ISO 11810-2:2007 D. Ophthalmic 53 Ophthalmic optics—Contact Lenses -- Part 1: Vocabulary, Classification System and Recommendations for Labeling Specifications ISO 18369-1:2006 54 Ophthalmic Optics- Contact Lenses- Part 4: Physicochemical Properties of Contact Lens Materials ISO 18369-4:2006 55 Ophthalmic implants -- Intraocular Lenses -- Part 6: Shelf-life and Transport Stability ISO 11979-6:2007 E. Radiology 171 Optics and Photonics -- Microlens Arrays -- Part 2: Test Methods for Wavefront Aberrations ISO 14880-2:2006 172 Optics and Photonics -- Microlens Arrays -- Part 3: Test Methods for Optical Properties Other than Wavefront Aberrations ISO 14880-3:2006 173 Optics and Photonics -- Microlens Arrays -- Part 4: Test Methods for Geometrical Properties ISO 14880-4:2006 174 Optics and Photonics -- Lasers and Laser-related Equipment -- Test Methods for Specular Reflectance and Regular Transmittance of Optical Laser Components ISO 13697:2006 175 Optics and Photonics -- Lasers and Laser-related Equipment -- Measurement of Phase Retardation of Optical Components for Polarized Laser Radiation ISO 24013:2006 176 Evaluation and Routine Testing in Medical Imaging Departments - Part 3-2: Acceptance Tests - Imaging Performance of Mammographic X-ray Equipment IEC 61223-3-2 Ed. 2.0 (2007) F. Sterility 238 Sterilization of Health Care Products - Chemical Indicators - Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal Tests ANSI/AAMI/ISO11140-5:2007 239 Aseptic Processing of Health Care Products—Part 3: Lyophilization ISO 13408-3:2006 240 Aseptic Processing of Health Care Products—Part 5: Sterilization-in-place ISO 13408-5:2006 241 Aseptic Processing of Health Care Products—Part 6: Isolator Systems ISO 13408-6:2005 242 Cleanrooms and Associated Controlled Environments—Part 3: Test Methods ISO 14644-3:2005 243 Cleanrooms and Associated Controlled Environments—Part 6: Vocabulary ISO 14644-6:2007 244 Cleanrooms and Associated Controlled Environments - Part 8: Classification of Airborne Molecular Contamination ISO 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 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 “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 . Dated: December 13, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-24580 Filed 12-18-07; 8:45 am] BILLING CODE 4160-01-S --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3AE7-24580. Public record. Not legal advice.