Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 036, 38910-38920 [2014-15989]

Download as PDF 38910 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through electronic or written comments, which can be submitted to the Division of Dockets Management (see Location). For context, please indicate if you are commenting as a patient with a heritable bleeding disorder or on behalf of a child or loved one. Topic 1: The effects of your bleeding disorder that matter most to you • Of all of the symptoms that you experience because of your condition, which one to three symptoms (bleeding or non-bleeding) have the most significant impact on your life? (Examples may include joint damage/ pain, infections, prolonged and heavy bleeding with menstruation, fatigue, etc.) • Are there specific activities that are important to you, but that you cannot do at all, or as well as you would like, because of your condition? Please describe, using specific examples. (Examples may include participating in physical activities, attending work/ school, and family/social activities, etc.) • How have your condition and its symptoms changed over time? • What worries you most about your condition? sroberts on DSK5SPTVN1PROD with NOTICES Topic 2: Perspectives on current approaches to treatment • What are you currently doing to treat your condition or its symptoms? (Examples may include blood transfusions, replacement therapies, over-the-counter products, and/or other therapies). Æ How well do these treatments work for you? Æ What are the most significant disadvantages or complications of your current treatments, and how do they affect your daily life? Æ How has your treatment changed over time and why? Æ What aspects of your condition are not improved by your current treatment regimen? Æ What treatment has had the most positive impact on your life? • If you could create your ideal treatment, what would it do for you (i.e., what specific things would you look for in an ideal treatment)? • If you had the opportunity to consider participating in a clinical trial studying experimental treatments, what things would you consider when deciding whether or not to participate? VerDate Mar<15>2010 20:08 Jul 08, 2014 Jkt 232001 B. Attendance and/or Participation in the Meeting If you wish to attend this meeting, visit https://www.eventbrite.com/e/ patient-focused-public-meeting-onheritable-bleeding-disordersregistration-11996980291. Please register by September 12, 2014. Those who are unable to attend the meeting in person can register to view a live Webcast of the meeting. You will be asked to indicate in your registration if you plan to attend in person or via the Webcast. Your registration will also contain your complete contact information, including name, title, affiliation, address, email address, and phone number. Seating will be limited, so early registration is recommended. Registration is free and will be on a firstcome, first-served basis. However, FDA may limit the number of participants from each organization based on space limitations. Registrants will receive confirmation once they have been accepted. Onsite registration on the day of the meeting will be based on space availability. If you need special accommodations because of disability, please contact Henry Allen (see Contact Person) at least 7 days before the meeting. Patients and patient stakeholders who are interested in presenting comments as part of the initial panel discussions should register by August 22, 2014. You will be asked to indicate in your registration which topic(s) you wish to address. You will be asked to send a brief summary of responses to the topic questions to PatientFocused_CBER@fda.hhs.gov. Panelists will be notified of their selection soon after August 22, 2014. FDA will try to accommodate all patients and patient advocate participants who wish to speak, either through the panel discussion or audience participation; however, the duration of comments may be limited by time constraints. Comments: Interested members of the public, including those who attend the meeting in person or via the Webcast, are invited to provide electronic or written responses to any or all of the questions pertaining to topics 1 and 2 to the Division of Dockets Management (see Location). Comments may be submitted until November 28, 2014. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Transcripts: Please be advised that as soon as a transcript is available, it will PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 be accessible at https://www.fda.gov/ BiologicsBloodVaccines/NewsEvents/ WorkshopsMeetingsConferences/ ucm401761.htm and at https:// www.regulations.gov. It may be viewed at the Division of Dockets Management (see Location). A transcript will also be available in either hardcopy or on CD– ROM, after submission of a Freedom of Information request. Written requests are to be sent to the Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. Dated: July 2, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–15990 Filed 7–8–14; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 036 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or we) 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: 036’’ (‘‘Recognition List Number: 036’’), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit either electronic or written comments concerning this document at any time. See section VII for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of the document entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 036’’ to the Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, SUMMARY: E:\FR\FM\09JYN1.SGM 09JYN1 38911 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices MD 20993–0002. Send two selfaddressed adhesive labels to assist that office in processing your request, or fax your request to 301–847–8149. Submit electronic comments on this document to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. An electronic copy of Recognition List Number: 036 is available on the Internet at https:// www.fda.gov/MedicalDevices/Device RegulationandGuidance/Standards/ ucm123792.htm. See section VI for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 036 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301–796–6287, standards@ cdrh.fda.gov. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105–115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the FD&C 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 we would implement our 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, can be accessed at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains HTML and PDF versions of the list of FDA Recognized Consensus Standards. Both versions are publicly accessible at the Agency’s Internet site. See section VI 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: 036 FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency will recognize for use in premarket submissions and other requirements for devices. We will incorporate these modifications in the list of FDA Recognized Consensus Standards in the Agency’s searchable database. We will use the term ‘‘Recognition List Number: 036’’ to identify these current modifications. In table 1, we describe the following modifications: (1) The withdrawal of standards and their replacement by others, if applicable, (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, we list modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Old recognition No. Replacement recognition No. Title of standard 1 Change A. Anesthesia 1–58 .............. 1–99 ............. 1–77 .............. 1–100 ........... 1–80 .............. 1–101 ........... ASTM G175–13 Standard test method for evaluating the ignition sensitivity and fault tolerance of oxygen pressure regulators used for medical and emergency applications. CGA V1:2013 Standard for compressed gas cylinder valve outlet and inlet connections. CGA C–9:2013 Standard color marking of compressed gas containers for medical use. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. B. Biocompatibility ...................... 2–133 ............ ...................... 2–136 ............ ...................... 2–141 ............ sroberts on DSK5SPTVN1PROD with NOTICES 2–117 ............ ...................... 2–145 ............ ...................... 2–146 ............ 2–206 ........... 2–153 ............ ...................... VerDate Mar<15>2010 20:08 Jul 08, 2014 ANSI/AAMI/ISO 10993–3:2003/(R) 2013 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. ASTM F1408–97 (Reapproved 2013) Standard practice for subcutaneous screening test for implant materials. ASTM E1262–88 (Reapproved 2013) Standard guide for performance of the Chinese hamster ovary cell/hypoxanthine guanine phosphoribosyl transferase gene mutation assay. ASTM F1984–99 (Reapproved 2013) Standard practice for testing for whole complement activation in serum by solid materials. ASTM F1439–03 (Reapproved 2013) Standard guide for performance of lifetime bioassay for the tumorigenic potential of implant materials. ASTM F2148–13 Standard practice for evaluation of delayed contact hypersensitivity using the murine local lymph node assay (LLNA). ANSI/AAMI/ISO 10993–5:2009/(R) 2014 Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity. Jkt 232001 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Reaffirmation. 09JYN1 38912 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 2–154 ............ 2–207 ........... 2–156 ............ ...................... 2–175 ............ ...................... 2–199 ............ 2–208 ........... 2–200 ............ 2–209 ........... 2–201 ............ 2–210 ........... 2–202 ............ 2–211 ........... 2–203 ............ 2–212 ........... Title of standard 1 Change ASTM F756–13 Standard practice for assessment of hemolytic properties of materials. ANSI/AAMI/ISO 10993–1:2009/(R) 2013 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process. ISO 10993–3 Second edition 2003–10–15, Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity. USP 37–NF32:2014 <87> Biological reactivity test, in vitro—direct contact test. USP 37–NF32:2014 <87> Biological reactivity test, in vitro— elution test. USP 37–NF32:2014 <88> Biological reactivity test, in vivo, procedure preparation of sample. USP 37–NF32:2014 <88> Biological reactivity test, in vitro, classification of plastics—intracutaneous test. USP 37–NF32:2014 <88> Biological reactivity test, in vivo, classification of plastics—systemic injection test. Withdrawn and replaced with newer version. Reaffirmation. Extent of recognition. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer C. Cardiovascular 3–42 .............. ...................... 3–65 .............. ...................... 3–72 .............. 3–129 ........... 3–77 .............. ...................... 3–78 .............. 3–130 ........... 3–79 .............. ...................... 3–82 .............. 3–125 ........... 3–95 .............. 3–126 ........... ANSI/AAMI EC13:2002/(R)2007 Cardiac monitors, heart rate meters, and alarm. ANSI/AAMI EC38:2007 Medical electrical equipment—Part 2–47: Particular requirements for the safety including essential performance of ambulatory electrocardiographic systems. ANSI/AAMI EC53:2013 ECG trunk cables and patient lead wires ... ANSI/AAMI PC69:2007 Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators. ANSI/AAMI/ISO 80601–2–30:2009 and A1:2013 Medical electrical equipment—Part 2–30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers [Amendment 1:2013]. F2070–09 (Reapproved 2013) Standard test method for measuring intrinsic elastic recoil of balloon-expandable stents. ISO 5841 Third edition 2013–04–15 Implants for surgery—Cardiac pacemakers—Part 3: Low-profile connectors [IS–1] for implantable pacemakers. IEC 60601–2–27 Edition 3.0 2011–03 Medical electrical equipment—Part 2–27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]. Withdrawn. See 3–101. Withdrawn. See 3–127. Withdrawn and replaced with newer version. Withdrawn. See 3–128. Withdrawn and replaced with newer version. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version including technical corrigendum. D. Dental/ENT ...................... ...................... 4–97 .............. ...................... 4–149 ............ ...................... 4–160 ............ ...................... 4–162 ............ ...................... 4–163 ............ sroberts on DSK5SPTVN1PROD with NOTICES 4–92 .............. 4–96 .............. ...................... 4–165 ............ ...................... 4–171 ............ ...................... 4–175 ............ 4–211 ........... 4–177 ............ ...................... VerDate Mar<15>2010 20:08 Jul 08, 2014 ANSI/ADA Standard No. 88 (Reaffirmed 2012) Dental brazing alloys ANSI/ADA Specification No. 30 (Reaffirmed 2010) Dental zinc oxide—eugenol and zinc oxide—non-eugenol cements. ANSI/ADA Standard No. 57 (Reaffirmed 2012) Endodontic sealing materials. ANSI/ADA Specification No. 39 (Reaffirmed 2011) Pit and fissure sealants. ANSI S3.1 (Reaffirmed 2013) Maximum permissible ambient noise levels for audiometric test rooms. ANSI S3.4–2007 (Reaffirmed 2012) Procedure for the computation of loudness of steady sounds. ANSI S3.5–1987 (Reaffirmed 2012) American national standard methods for calculation of the speech intelligibility index. ANSI S3.13–1987 (Reaffirmed 2012) American national standard mechanical coupler for measurement of bone vibrators. ANSI S3.37–1987 (Reaffirmed 2012) American national standard preferred earhook nozzle thread for postauricular hearing aids. ANSI S3.46–2013 American national standard method of measurement of real-ear performance characteristics of hearing aids. ANSI S12.65–2006 (Reaffirmed 2011) American national standard for rating noise with respect to speech interference. Jkt 232001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Reaffirmation. 09JYN1 38913 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 4–179 ............ 4–212 ........... 4–193 ............ ...................... Title of standard 1 Change ISO 7405 Second edition 2008–12–15 Dentistry—Evaluation of biocompatibility of medical devices used in dentistry [Including: Amendment 1 (2013)]. ANSI/ADA Standard No. 15 (Reaffirmed 2013) Artificial teeth for dental prostheses. Withdrawn and replaced with newer version including amendment. Reaffirmation. E. General I (Quality Systems/Risk Management (QS/RM)) ...................... 5–23 .............. ...................... 5–50 .............. 5–87 ............. 5–53 .............. 19–1 ............. 5–54 .............. 19–2 ............. 5–66 .............. 19–3 ............. 5–77 .............. 19–4 ............. 5–78 .............. 19–5 ............. 5–81 .............. 5–88 ............. 5–82 .............. 19–6 ............. 5–83 .............. 19–7 ............. 5–85 .............. ...................... 5–73 .............. 5–90 ............. 5–75 .............. sroberts on DSK5SPTVN1PROD with NOTICES 5–22 .............. 5–91 ............. 5–57 .............. ...................... 5–67 .............. ...................... ISO 2768-l First edition 1999–11–15 General tolerances—Part 1: Tolerances for linear and angular dimensions without individual tolerance indications. ISO 2768–2 First edition 1989–11–15 General tolerances—Part 2: Geometrical tolerances for features without individual tolerance indications. IEC 62366 Edition 1.1 2014–01 Medical devices—Application of usability engineering to medical devices. IEC 60601–1–2 Edition 3:2007–03 Medical electrical equipment— Part 1–2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility— Requirements and tests. ANSI/AAMI/IEC 60601–1–2:2007/(R)2012 Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic compatibility—Requirements and tests. IEC 60601–1–10 Edition 1.0 2007–11 Medical electrical equipment—Part 1–10: General requirements for basic safety and essential performance—Collateral standard: Requirements for the development of physiologic closed-loop controllers. ANSI/AAMI ES60601–1:2005/(R)2012 and A1:2012,C1:2009/ (R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601–1:2005, mod). ANSI/AAMI ES60601–1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (consolidated text) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601–1:2005, mod). ISO 2859–1 First edition 1999–11–15 Sampling procedures for inspection by attributes—Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Corrigendum 1 (2001), Amendment 1 (2011)]. IEC 60601–1–11 Edition 1.0 2010–04 Medical electrical equipment—Part 1–11: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [including: Technical corrigendum 1 (2011)]. ANSI/AAMI HA60601–1–11:2011 Medical electrical equipment— Part 1–11: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601–1–11:2010 mod). IEC 60601–1–6 Edition 3.0 2010–01 Medical electrical equipment—Part 1–6: General requirements for basic safety and essential performance—Collateral standard: Usability. ISO 15223–1 Second edition 2012–07–01 Medical devices—Symbols to be used with medical device labels, labeling, and information to be supplied—Part 1: General requirements. AAMI/ANSI/ISO 15223–1:2012 Medical devices—Symbols to be used with medical devices labels, labeling, and information to be supplied—Part 1: General requirements. AAMI/ANSI HE75:2009 Human factors engineering—Design of medical devices. ANSI/AAMI/IEC 62366:2007/(R)2013 Medical devices—Application of usability engineering to medical devices. Withdrawn. Withdrawn. Withdrawn and replaced with newer version. Transferred to General II (ES/EMC). Transferred to General II (ES/EMC). Transferred to General II (ES/EMC). Transferred to General II (ES/EMC). Transferred to General II (ES/EMC). Withdrawn and replaced with newer version including amendment. Transferred to General II (ES/EMC). Transferred to General II (ES/EMC). Transition period added. Extent of recognition. Extent of recognition. Relevant guidance. Relevant guidance. F. General Hospital/General Plastic Surgery 6–180 ............ VerDate Mar<15>2010 ...................... 20:08 Jul 08, 2014 ASTM F2407–06 (Reapproved 2013) Standard specification for surgical gowns intended for use in healthcare facilities. Jkt 232001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM Reaffirmation. 09JYN1 38914 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 6–184 ............ 6–323 ........... 6–234 ............ 6–324 ........... 6–300 ............ 6–325 ........... 6–309 ............ Title of standard 1 Change Withdrawn and replaced with newer version. 6–326 ........... ASTM F1862/F1862M–13 Standard test method for resistance of medical face masks to penetration by synthetic blood (horizontal projection of fixed volume at a known velocity). IEC 60601–2–50 Edition 2.0 2009–03 Medical electrical equipment—Part 2–50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Technical corrigendum 1 (2010)]. IEC 60601–2–21 Edition 2.0 2009–02 Medical electrical equipment—Part 2–21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Technical corrigendum 1 (2013)]. USP 37–NF 33:2014 Sodium chloride irrigation ............................... 6–310 ............ 6–327 ........... USP 37–NF 33:2014 Sodium chloride injection ................................ 6–311 ............ 6–328 ........... USP 37–NF 33:2014 Nonabsorbable surgical suture ....................... 6–312 ............ 6–329 ........... USP 37–NF 33:2014 <881> Tensile strength ..................................... 6–313 ............ 6–330 ........... USP 37–NF 33:2014 <861> Sutures—Diameter .............................. 6–314 ............ 6–331 ........... USP 37–NF 33:2014 <871> Sutures—Needle attachment .............. 6–315 ............ 6–332 ........... USP 37–NF 33:2014 Sterile water for irrigation ............................... 6–316 ............ 6–333 ........... USP 37–NF 33:2014 Heparin lock flush solution ............................. 6–317 ............ 6–334 ........... USP 37–NF 33:2014 Absorbable surgical suture ............................. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer G. In Vitro Diagnostics ...................... 7–112 ............ ...................... 7–133 ............ 7–246 ........... 7–142 ............ ...................... 7–162 ............ ...................... 7–175 ............ ...................... 7–201 ............ ...................... 7–203 ............ ...................... 7–213 ............ ...................... 7–221 ............ ...................... 7–241 ............ sroberts on DSK5SPTVN1PROD with NOTICES 7–48 .............. 7–247 ........... CLSI C60–A (Formerly T/DM06–A) Blood alcohol testing in the clinical laboratory; Approved guideline. CLSI POCT14–A (Formerly H49–A) Point-of-care monitoring of anticoagulation therapy; Approved guideline. CLSI POCT12–A3 Point-of-care blood glucose testing in acute and chronic care facilities; Approved guideline—Third edition. CLSI GP43–A4 (Replaces H11–A4) Procedures for the collection of arterial blood specimens; Approved standard—Fourth edition. CLSI POCT14–A (Formerly H49–A) Point-of-care monitoring of anticoagulation therapy; Approved guideline. CLSI C59–A (Formerly I/LA15–A) Apolipoprotein immunoassays: Development and recommended performance characteristics; Approved guideline. CLSI GP41–A6 (Replaces H03–A6) Procedures for the collection of diagnostic blood specimens by venipuncture; Approved standard—Sixth edition. CLSI GP42–A6 (Replaces H04–A6) Procedures and devices for the collection of diagnostic capillary blood specimens; Approved standard—Sixth edition. CLSI GP44–A4 (Replaces H18–A4) Procedures for the handling and processing of blood specimens for common laboratory tests; Approved guideline—Fourth edition. CLSI GP39–A6 (Replaces H01–A6) Tubes and additives for venous and capillary blood specimen collection; Approved standard— Sixth edition. CLSI M100–S24 Performance standards for antimicrobial susceptibility testing; Twenty-fourth informational supplement. Designation number. Designation number. Withdrawn and replaced with newer version. Designation number. Designation number. Designation number. Designation number. Designation number. Designation number. Designation number. Withdrawn and replaced with newer version. H. Materials 8–173 ............ 8–371 ........... 8–183 ............ 8–372 ........... 8–193 ............ ...................... VerDate Mar<15>2010 20:08 Jul 08, 2014 ASTM F601–13 Standard practice for fluorescent penetrant inspection of metallic surgical implants. ASTM F560–13 Standard specification for unalloyed tantalum for surgical implant applications (UNS R05200, UNS R05400). ASTM F2754/F2754M–09 (Reapproved 2013) Standard test method for measurement of camber, cast, helix, and direction of helix of coiled wire. Jkt 232001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Reaffirmation. 09JYN1 38915 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 8–198 ............ 8–373 ........... 8–199 ............ 8–374 ........... 8–221 ............ 8–375 ........... 8–224 ............ 8–376 ........... 8–341 ............ 8–377 ........... 8–364 ............ 8–378 ........... 8–366 ............ 8–379 ........... Title of standard 1 Change ASTM F2102–13 Standard guide for evaluating the extent of oxidation in polyethylene fabricated forms intended for surgical implants. ASTM F2633–13 Standard specification for wrought seamless nickel-titanium shape memory alloy tube for medical devices and surgical implants. ASTM F2066–13 Standard specification for wrought titanium-15 molybdenum alloy for surgical implant applications (UNS R58150). ASTM F2102–13 Standard guide for evaluating the extent of oxidation in polyethylene fabricated forms intended for surgical implants. ASTM F136–13 Standard specification for wrought titanium6aluminum-4vanadium ELI (extra low interstitial) alloy for surgical implant applications (UNS R56401). ASTM D792–13 Standard test methods for density and specific gravity (relative density) of plastics by displacement. ISO 11542–2 First edition 1998–11–15 Plastics—Ultra-high-molecular-weight polyethylene (PE–UHMW) moulding and extrusion materials—Part 2: Preparation of test specimens and determination of properties [Including: Technical corrigendum 1 (2007)]. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version including technical corrigendum. I. Nanotechnology 18–2 .............. ...................... ASTM E2535–07 (Reapproved 2013) Standard guide for handling unbound engineered nanoscale particles in occupational settings. Reaffirmation. J. Neurology 17–10 ............ ...................... ANSI/AAMI/ISO 14708–3:2008/(R)2011 Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators. Reaffirmation. K. OB–GYN/Gastroenterology/Urology 9–44 .............. ...................... 9–87 .............. 9–93 ............. 9–21 .............. 9–94 ............. ASTM F623–99 (Reapproved 2013) Standard performance specification for Foley catheter. ISO 25841 Second edition 2014–01–15 Female condoms—Requirements and test methods. ISO 8600–4 Second edition 2014–03–15 Optics and optical instruments—Medical endoscopes and certain accessories—Part 4: Determination of maximum width of insertion portion. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. L. Orthopedic 11–211 .......... 11–276 ......... 11–237 .......... 11–277 ......... 11–255 .......... 11–278 ......... ASTM F1798–13 Standard test method for evaluating the static and fatigue properties of interconnection mechanisms and subassemblies used in spinal arthrodesis implants. ISO 7206–6 Second edition 2013–11–15 Implants for surgery— Partial and total hip joint prostheses—Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components. ASTM F1717–14 Standard test methods for spinal implant constructs in a vertebrectomy model. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. M. Radiology ...................... 12–24 ............ sroberts on DSK5SPTVN1PROD with NOTICES 12–23 ............ ...................... 12–25 ............ ...................... 12–26 ............ ...................... 12–27 ............ ...................... VerDate Mar<15>2010 20:08 Jul 08, 2014 NEMA XR 10–1986 (R1992, R1998, R2003) Measurement of the maximum symmetrical radiation field from a rotating anode x-ray tube used for medical diagnosis. NEMA XR 11–1993 (R1999) Test standard for determination of the limiting spatial resolution of x-ray image intensifier systems. NEMA XR 15–1991 (R1996, R2001) Test standard for the determination of the visible entrance field size of an x-ray image intensifier system. NEMA XR 16–1991 (R1996, R2001) Test standard for the determination of the system contrast ratio and the system veiling glare index of an x-ray image intensifier system. NEMA XR 17–1993 (R1999) Test standard for the measurement of the image signal uniformity of an x-ray image intensifier system. Jkt 232001 PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM Withdrawn. Withdrawn. Withdrawn. Withdrawn. Withdrawn. 09JYN1 38916 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 12–28 ............ ...................... 12–29 ............ ...................... 12–66 ............ 12–271 ......... 12–79 ............ ...................... 12–80 ............ ...................... 12–81 ............ ...................... 12–82 ............ ...................... 12–100 .......... ...................... 12–146 .......... 12–272 ......... 12–168 .......... 12–273 ......... 12–193 .......... ...................... 12–194 .......... ...................... 12–201 .......... 12–274 ......... 12–220 .......... ...................... 12–239 .......... ...................... 12–240 .......... ...................... Title of standard 1 Change NEMA XR 18–1993 (R1999) Test standard for the determination of the radial image distortion of an x-ray image intensifier system. NEMA XR 19–1993 (R1999) Electrical, thermal, and loading characteristics of x-ray tubes used for medical diagnosis. AIUM MUS Medical ultrasound safety, third edition ......................... NEMA XR7–1995 (R2000) High-voltage x-ray cable assemblies and receptacles. NEMA XR 9–1984 (R1994, R2000) Power supply guidelines for xray machines. NEMA XR 13–1990 (R1995, R2000) Mechanical safety standard for power driven motions of electromedical equipment. NEMA XR 14–1990 (R1995, R2000) Recommended practices for load bearing mechanical assemblies used in diagnostic imaging. NEMA UD 3–2004 (R2009) Standard for real time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment. IEC 60601–2–17 Edition 3.0 2013–11 Medical electrical equipment—Part 2–17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment. IEC 60825–1 Edition 2.0 2007–03 Safety of laser products—Part 1: Equipment classification and requirements [Including: Technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]. AIUM AOL 2008 Acoustic output labeling standard for diagnostic ultrasound equipment revision 1—A standard for how manufacturers should specify acoustic output data. ANSI/HPS N43.6–2007 (R2013) Sealed radioactive sources—Classification. IEC 60601–2–54 Edition 1.0 2009–06 Medical electrical equipment—Part 2–54: Particular requirements for the basic safety and essential performance of x-ray equipment for radiography and radioscopy [Including: Technical corrigendum 1 (2010), technical corrigendum 2 (2011)]. IEC 60825–1 (Second edition-2007) Safety of laser products—Part 1: Equipment classification and requirements corrigendum 1. IEC 60825–1 (Second edition-2007) I–SH 01 Safety of laser products—Part 1: Equipment classification and requirements, interpretation sheet 1. IEC 60825–1 (2007) Second edition, I–SH 02 Safety of laser products—Part 1: Equipment classification and requirements, interpretation sheet 2. Withdrawn. Withdrawn. Withdrawn and replaced with newer version. Withdrawn. Withdrawn. Withdrawn. Withdrawn. Withdrawn Withdrawn and replaced with newer version. Withdrawn and replaced with newer version including technical corrigendum and interpretation sheets. Withdrawn. Reaffirmation. Withdrawn and replaced with newer version including technical corrigendum. Withdrawn. See 12–273. Withdrawn. See 12–273. Withdrawn. See 12–273. N. Software/Informatics 13–65 ........... 13–15 ............ ...................... 13–46 ............ ...................... 13–58 ............ sroberts on DSK5SPTVN1PROD with NOTICES 13–4 .............. 13–66 ........... ANSI/UL 1998 Third edition 2013 Standard for software in programmable components. CLSI AUTO13–A2 Laboratory instruments and data management systems: Design of software user interfaces and end-user software systems validation, operation, and monitoring; Approved guideline—second edition. ASTM F2761–09 (2013) Medical devices and medical systems—Essential safety requirements for equipment comprising the patientcentric integrated clinical environment (ICE)—Part 1: General requirements and conceptual model. ISO/IEEE 11073–10417 First edition 2014–03–01 Health informatics—Personal health device communication—Part 10417: Device specialization: Glucose meter. Withdrawn and replaced with newer version. New designation number. Reaffirmation. Withdrawn and replaced with newer version. O. Sterility 14–181 .......... 14–432 ......... 14–228 .......... ...................... VerDate Mar<15>2010 20:08 Jul 08, 2014 ANSI/AAMI ST58:2013 Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI/ISO 11135–1:2007 Sterilization of healthcare products—Ethylene oxide—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. Jkt 232001 PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM Withdrawn and replaced with newer version. Withdrawn. See 14–452. 09JYN1 38917 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. 14–232 .......... 14–433 ......... 14–233 .......... 14–434 ......... 14–256 .......... ...................... 14–257 .......... ...................... 14–259 .......... 14–435 ......... 14–261 .......... ...................... 14–282 .......... ...................... 14–286 .......... ...................... 14–288 .......... ...................... 14–290 .......... ...................... 14–291 .......... ...................... 14–331 .......... 14–452 ......... 14–342 .......... ...................... 13–343 .......... ...................... 14–348 .......... ...................... 14–364 .......... 14–438 ......... 14–394 .......... 14–439 ......... 14–414 .......... 14–440 ......... 14–415 .......... Change Withdrawn and replaced with newer version. 14–441 ......... ASTM F2227–13 Standard test method for non-destructive detection of leaks in non-sealed and empty packaging trays by CO2 tracer gas method. ASTM F2228–13 Standard test method for non-destructive detection of leaks in packaging which incorporates porous barrier material by CO2 tracer gas method. ASTM F2095–07 (Reapproved 2013) Standard test methods for pressure decay leak test for flexible packages with and without restraining plates. ASTM D3078–02 (Reapproved 2013) Standard test method for determination of leaks in flexible packaging by bubble emission. ASTM F2251–13 Standard test method for thickness measurement of flexible packaging material. ANSI/AAMI/ISO 17665–1:2006/(R)2013 Sterilization of health care products—Moist heat—Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. ASTM F2338–09 (Reapproved 2013) Standard test method for nondestructive detection of leaks in packages by vacuum decay method. ANSI/AAMI ST65:2008/(R)2013 Processing of reusable surgical textiles for use in health care facilities. ASTM F1886/F1886M–09 (Reapproved 2013) Standard test method for determining integrity of seals for flexible packaging by visual inspection. ANSI/AAMI ST24:1999/(R)2013 Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities. ANSI/AAMI/ISO 14937:2009/(R)2013 Sterilization of healthcare products—General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices. ISO 11135 Second edition 2014 Sterilization of healthcare products—Ethylene oxide—Requirements for the development, validation, and routine control of a sterilization process for medical devices. ASTM E2628–09 (E2009) Standard practice for dosimetry in radiation. ASTM E2701–09 Standard guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing. ANSI/AAMI/ISO 13408–2:2003/(R)2013 Aseptic processing of healthcare products—Part 2: Filtration. ANSI/AAMI/ISO 11137–2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose. ANSI/AAMI ST79:2010, A1:2010, A2:2011, A3:2012, and A4:2013 (consolidated text) Comprehensive guide to steam sterilization and sterility assurance in health care facilities. USP 37NF32:2014 Microbiological examination of nonsterile products: Microbial enumeration tests. USP 37NF32:2014 Sterility tests ....................................................... 14–416 .......... 14–442 ......... USP 37NF32:2014 Bacterial endotoxins test .................................... 14–417 .......... 14–443 ......... USP 37NF32:2014 Pyrogen test (USP rabbit test) ........................... 14–418 .......... 14–444 ......... 14–419 .......... sroberts on DSK5SPTVN1PROD with NOTICES Title of standard 1 14–445 ......... 14–420 .......... 14–446 ......... 14–421 .......... 14–447 ......... 14–422 .......... 14–448 ......... 14–423 .......... 14–449 ......... USP 37NF32:2014 Transfusion and infusion assemblies and similar medical devices. USP 37NF32:2014 Biological indicator for steam sterilization—Selfcontained. USP 37NF32:2014 Biological indicator for dry-heat sterilization, paper carrier. USP 37NF32:2014 Biological indicator for ethylene oxide sterilization, paper carrier. USP 37NF32:2014 Biological indicator for steam sterilization, paper carrier. USP 37NF32:2014 Microbiological examination of nonsterile products: Tests for specified microorganisms. VerDate Mar<15>2010 20:08 Jul 08, 2014 Jkt 232001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn. See 14–436. Withdrawn. See 14–437. Reaffirmation. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. Withdrawn version. 09JYN1 and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer and replaced with newer 38918 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued Old recognition No. Replacement recognition No. Title of standard 1 14–425 .......... ...................... ANSI/AAMI/ISO 13408–6:2005/(R)2013 and A1:2013 Aseptic processing of healthcare products—Part 6: Isolator systems. Change Reaffirmation. P. Tissue Engineering 15–21 ............ 15–39 ........... 15–26 ............ 15–40 ........... 15–33 ............ 15–41 ........... 1 All ASTM F2150–13 Standard guide for characterization and testing of biomaterial scaffolds used in tissue-engineered medical products(TEMPs). ASTM F2211–13 Standard classification for tissue-engineered medical products (TEMPs). ASTM F2602–13 Standard test method for determining the molar mass of chitosan and chitosan salts by size exclusion chromatography with multi-angle light scattering detection (SEC–MALS). Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. standard titles in this table conform to the style requirements of the respective organizations. III. Listing of New Entries In table 2, we provide the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 036. TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Title of standard 1 Recognition No. Reference No. and date A. Cardiovascular 3–127 ..................................... 3–128 ..................................... Medical electrical equipment—Part 2–47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems. Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices. ANSI/AAMI/IEC 60601–2–47:2012. ANSI/AAMI/ISO 14117:2012. B. General I (Quality System/Risk Management (QS/RM)) 5–89 ....................................... 5–92 ....................................... Medical electrical equipment—Part 1–6: General requirements for basic safety and essential performance—Collateral standard: Usability. Medical Electrical Equipment—Part 1–8: General requirements for basic safety and essential performance—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. IEC 60601–1–6 Edition 3.1 2013– 10. ANSI/AAMI/IEC 60601–1–8:2006 & A1:2012. C. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC)) 19–1 ....................................... 19–2 ....................................... 19–3 ....................................... 19–4 ....................................... Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral standard: electromagnetic compatibility—requirements and tests. Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral standard: electromagnetic compatibility—requirements and tests. Medical electrical equipment—Part 1–10: General requirements for basic safety and essential performance—Collateral standard: requirements for the development of physiologic closed-loop controllers. Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601–1:2005, mod). sroberts on DSK5SPTVN1PROD with NOTICES 19–5 ....................................... Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601–1:2005, mod). 19–6 ....................................... Medical electrical equipment—Part 1–11: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment [Including: Technical corrigendum 1 (2011)]. Medical electrical equipment—Part 1–11: General requirements for basic safety and essential performance—Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601–1–11:2010 mod). 19–7 ....................................... VerDate Mar<15>2010 20:08 Jul 08, 2014 Jkt 232001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\09JYN1.SGM IEC 60601–1–2 Edition 3:2007–03. ANSI/AAMI/IEC (R)2012. 60601–1–2:2007/ IEC 60601–1–10 Edition 1.0:2007– 11. ANSI/AAMI ES60601–1:2005/ (R)2012 and A1:2012,C1:2009/ (R)2012 and A2:2010/(R)2012. ANSI/AAMI ES60601–1:2005/ (R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012 (Consolidated text). IEC 60601–1–11 Edition 1.0:2010– 04. ANSI/AAMI HA60601–1–11:2011. 09JYN1 38919 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued Recognition No. Title of standard 1 Reference No. and date 19–8 ....................................... Medical electrical equipment—Part 1–2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests. Medical electrical equipment—Part 1–10: General requirements for basic safety and essential performance—Collateral standard: Requirements for the development of physiologic closed-loop controllers. Lithium batteries ............................................................................................ Household and commercial batteries ............................................................ IEC 60601–1–2 Edition 4.0:2014– 02. 19–9 ....................................... 19–10 ..................................... 19–11 ..................................... IEC 60601–1–10 Edition 1.1:2013– 11. UL 1642 5th Edition 2013. UL 2054 2nd Edition 2011. D. Orthopedics 11–279 ................................... 11–280 ................................... Standard practice for finite element analysis (FEA) of non-modular metallic orthopaedic hip femoral stems. Standard test method for static, dynamic, and wear assessment of extradiscal single level spinal constructs. ASTM F2996–13. ASTM F2624–12. E. Radiology 12–275 ................................... 12–276 ................................... 12–277 ................................... 12–278 ................................... 12–279 ................................... 12–280 ................................... 12–281 ................................... 12–282 ................................... 12–283 ................................... Ultrasonics—Power measurement—Radiation force balances and performance requirements. Ultrasonics—Output test—Guide for the maintenance of ultrasound physiotherapy systems. Ultrasonics—Hydrophones—Part 1: Measurement and characterization of medical ultrasonic fields up to 40 megahertz (MHz). Ultrasonics—Hydrophones—Part 2: Calibration for ultrasonic fields up to 40 MHz (including corrigendum 1:2008 and amendment 1:2013). Ultrasonics—Hydrophones—Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz. Ultrasonics—Power measurement—High intensity therapeutic ultrasound (HITU) transducers and systems. Medical electrical equipment—Part 2–62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment. Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications—Part 1: Specification for products. Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications—Part 2: Guidance for use. IEC 61161 Edition 3.0:2013–01. IEC TS 62462 First edition 2007– 05. IEC 62127–1 Edition 1.1:2013–02. IEC 62127–2 Edition 1.0:2007–08. IEC 62127–3 Edition 1.1:2013–05. IEC 62555 Edition 1.0:2013–11. IEC 60601–2–62 Edition 1.0:2013– 07. ISO 12609–1 First edition 2013– 07–15. ISO 12609–2 First edition 2013– 07–15. F. Software/Informatics 13–67 ..................................... 13–68 ..................................... 13–69 ..................................... Health informatics—Personal health device communication—Part 10418: Device specialization—International normalized ratio (INR) monitor. Health informatics—Point-of-care medical device communication—Part 90101: Analytical instruments—Point-of-care test. Health Informatics—Personal health device communication—Part 10472: Device specialization—Medication monitor. ISO/IEEE 11073–10418 First edition 2014–03–01. ISO 11073–90101 First edition 2008–01–15. ISO/IEEE 11073–10472 First edition 2012–11–01. G. Sterility 14–436 ................................... Practice for dosimetry in radiation processing .............................................. 14–437 ................................... Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing. Biological indicators—Resistance performance tests ................................... Biological indicators for sterilization .............................................................. 14–450 ................................... 14–451 ................................... sroberts on DSK5SPTVN1PROD with NOTICES 1 All ISO/ASTM 52628 2013–11–15. ISO/ASTM 52701 2013–11–15. USP 37–NF32:2014 USP 37–NF32:2014 First edition First edition <55>. <1035>. standard titles in this table conform to the style requirements of the respective organizations. 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 our Internet site at https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfStandards/ search.cfm. We will incorporate the modifications and revisions described in this notice into the database and, VerDate Mar<15>2010 20:08 Jul 08, 2014 Jkt 232001 upon publication in the Federal Register, this recognition of consensus standards will be effective. We will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary. Beginning with Recognition List 033, we will no longer announce minor revisions to the list of PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 recognized consensus standards such as technical contact person, devices affected, processes affected, Code of Federal Regulations citations, and product codes. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for E:\FR\FM\09JYN1.SGM 09JYN1 38920 Federal Register / Vol. 79, No. 131 / Wednesday, July 9, 2014 / Notices recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to www.standards@ cdrh.fda.gov. 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. sroberts on DSK5SPTVN1PROD with NOTICES VI. Electronic Access You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. The Center for Devices and Radiological Health (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: 036’’ will be available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ Standards/ucm123792.htm. You may access the CDRH home page at https:// www.fda.gov/MedicalDevices. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database for ‘‘FDA Recognized Consensus Standards’’ at https://www.fda.gov/ MedicalDevices/DeviceRegulationand Guidance/Standards. VII. Submission of Comments and Effective Date Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. FDA will consider any comments received in determining VerDate Mar<15>2010 20:08 Jul 08, 2014 Jkt 232001 whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 036. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. Dated: July 2, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–15989 Filed 7–8–14; 8:45 am] BILLING CODE 4164–01–P logging into the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/ scripts/FACTRSPortal/FACTRS/ index.cfm Gail Dapolito, Center for Biologics Evaluation and Research, 10903 New Hampshire Ave., Bldg. 71, Rm. 6124, Silver Spring, MD 20993–0002, 240– 402–8046; gail.dapolito@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: The Agency intends to add a nonvoting industry representative to the following advisory committee: SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration I. Cellular, Tissue, and Gene Therapies Advisory Committee [Docket No. FDA–2014–N–0899] Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative and Request for Nominations for Nonvoting Industry Representatives on the Cellular, Tissue, and Gene Therapies Advisory Committee AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current or upcoming vacancies effective with this notice. DATES: Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests must send a letter stating that interest to FDA by August 8, 2014, for the vacancy listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA by August 8, 2014. ADDRESSES: All letters of interest from industry organizations should be submitted in writing to Gail Dapolito (see FOR FURTHER INFORMATION CONTACT). All nominations should be submitted by SUMMARY: PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 The Committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions. The Committee also considers the quality and relevance of FDA’s research program which provides support for the regulation of these products, and makes appropriate recommendations to the Commissioner of Food and Drugs (the Commissioner). II. Selection Procedure Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interests should send a letter stating that interest to the FDA contact (see FOR FURTHER INFORMATION CONTACT) within 30 days of publication of this document (see DATES). Within the subsequent 30 days, FDA will send a letter to each organization that has expressed an interest, attaching a complete list of all such organizations, and a list of all nominees along with their current resumes. The letter will also state that it is the responsibility of the interested organizations to confer with one another and to select a candidate, within 60 days after the receipt of the FDA letter, to serve as the nonvoting member to represent industry interests for the committee. The interested organizations are not bound by the list of nominees in selecting a candidate. However, if no individual is selected within 60 days, the Commissioner will select the nonvoting member to represent industry interests. E:\FR\FM\09JYN1.SGM 09JYN1

Agencies

[Federal Register Volume 79, Number 131 (Wednesday, July 9, 2014)]
[Notices]
[Pages 38910-38920]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15989]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 036

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) 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: 036'' (``Recognition List Number: 036''), will assist
manufacturers who elect to declare conformity with consensus standards
to meet certain requirements for medical devices.

DATES: Submit either electronic or written comments concerning this
document at any time. See section VII for the effective date of the
recognition of standards announced in this document.

ADDRESSES: Submit written requests for single copies of the document
entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 036'' to the Division of Industry and Consumer
Education, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring,

[[Page 38911]]

MD 20993-0002. Send two self-addressed adhesive labels to assist that
office in processing your request, or fax your request to 301-847-8149.
Submit electronic comments on this document to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document. An electronic copy
of Recognition List Number: 036 is available on the Internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI for electronic access to the searchable
database for the current list of FDA recognized consensus standards,
including Recognition List Number: 036 modifications and other
standards related information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3632, Silver Spring, MD 20993, 301-796-
6287, standards@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Section 204 of the Food and Drug Administration Modernization Act
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food,
Drug, and Cosmetic Act (the FD&C 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 we would implement our 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, can be accessed at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains HTML and PDF
versions of the list of FDA Recognized Consensus Standards. Both
versions are publicly accessible at the Agency's Internet site. See
section VI 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: 036

FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions and other requirements for devices. We
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database. We will use
the term ``Recognition List Number: 036'' to identify these current
modifications.
In table 1, we describe the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable,
(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, we list modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.

Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement recognition
Old recognition No. No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-58...................... 1-99...................... ASTM G175-13 Standard test Withdrawn and replaced
method for evaluating the with newer version.
ignition sensitivity and
fault tolerance of oxygen
pressure regulators used for
medical and emergency
applications.
1-77...................... 1-100..................... CGA V1:2013 Standard for Withdrawn and replaced
compressed gas cylinder valve with newer version.
outlet and inlet connections.
1-80...................... 1-101..................... CGA C-9:2013 Standard color Withdrawn and replaced
marking of compressed gas with newer version.
containers for medical use.
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-117..................... .......................... ANSI/AAMI/ISO 10993-3:2003/(R) Reaffirmation.
2013 Biological evaluation of
medical devices--Part 3:
Tests for genotoxicity,
carcinogenicity, and
reproductive toxicity.
2-133..................... .......................... ASTM F1408-97 (Reapproved Reaffirmation.
2013) Standard practice for
subcutaneous screening test
for implant materials.
2-136..................... .......................... ASTM E1262-88 (Reapproved Reaffirmation.
2013) Standard guide for
performance of the Chinese
hamster ovary cell/
hypoxanthine guanine
phosphoribosyl transferase
gene mutation assay.
2-141..................... .......................... ASTM F1984-99 (Reapproved Reaffirmation.
2013) Standard practice for
testing for whole complement
activation in serum by solid
materials.
2-145..................... .......................... ASTM F1439-03 (Reapproved Reaffirmation.
2013) Standard guide for
performance of lifetime
bioassay for the tumorigenic
potential of implant
materials.
2-146..................... 2-206..................... ASTM F2148-13 Standard Withdrawn and replaced
practice for evaluation of with newer version.
delayed contact
hypersensitivity using the
murine local lymph node assay
(LLNA).
2-153..................... .......................... ANSI/AAMI/ISO 10993-5:2009/(R) Reaffirmation.
2014 Biological evaluation of
medical devices--Part 5:
Tests for in vitro
cytotoxicity.

[[Page 38912]]

2-154..................... 2-207..................... ASTM F756-13 Standard practice Withdrawn and replaced
for assessment of hemolytic with newer version.
properties of materials.
2-156..................... .......................... ANSI/AAMI/ISO 10993-1:2009/(R) Reaffirmation.
2013 Biological evaluation of
medical devices--Part 1:
Evaluation and testing within
a risk management process.
2-175..................... .......................... ISO 10993-3 Second edition Extent of recognition.
2003-10-15, Biological
evaluation of medical
devices--Part 3: Tests for
genotoxicity,
carcinogenicity, and
reproductive toxicity.
2-199..................... 2-208..................... USP 37-NF32:2014 <87> Withdrawn and replaced
Biological reactivity test, with newer version.
in vitro--direct contact test.
2-200..................... 2-209..................... USP 37-NF32:2014 <87> Withdrawn and replaced
Biological reactivity test, with newer version.
in vitro--elution test.
2-201..................... 2-210..................... USP 37-NF32:2014 <88> Withdrawn and replaced
Biological reactivity test, with newer version.
in vivo, procedure
preparation of sample.
2-202..................... 2-211..................... USP 37-NF32:2014 <88> Withdrawn and replaced
Biological reactivity test, with newer version.
in vitro, classification of
plastics--intracutaneous test.
2-203..................... 2-212..................... USP 37-NF32:2014 <88> Withdrawn and replaced
Biological reactivity test, with newer version.
in vivo, classification of
plastics--systemic injection
test.
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-42...................... .......................... ANSI/AAMI EC13:2002/(R)2007 Withdrawn. See 3-101.
Cardiac monitors, heart rate
meters, and alarm.
3-65...................... .......................... ANSI/AAMI EC38:2007 Medical Withdrawn. See 3-127.
electrical equipment--Part 2-
47: Particular requirements
for the safety including
essential performance of
ambulatory
electrocardiographic systems.
3-72...................... 3-129..................... ANSI/AAMI EC53:2013 ECG trunk Withdrawn and replaced
cables and patient lead wires. with newer version.
3-77...................... .......................... ANSI/AAMI PC69:2007 Active Withdrawn. See 3-128.
implantable medical devices--
Electromagnetic
compatibility--EMC test
protocols for implantable
cardiac pacemakers and
implantable cardioverter
defibrillators.
3-78...................... 3-130..................... ANSI/AAMI/ISO 80601-2-30:2009 Withdrawn and replaced
and A1:2013 Medical with newer version.
electrical equipment--Part 2-
30: Particular requirements
for the basic safety and
essential performance of
automated non-invasive
sphygmomanometers [Amendment
1:2013].
3-79...................... .......................... F2070-09 (Reapproved 2013) Reaffirmation.
Standard test method for
measuring intrinsic elastic
recoil of balloon-expandable
stents.
3-82...................... 3-125..................... ISO 5841 Third edition 2013-04- Withdrawn and replaced
15 Implants for surgery-- with newer version.
Cardiac pacemakers--Part 3:
Low-profile connectors [IS-1]
for implantable pacemakers.
3-95...................... 3-126..................... IEC 60601-2-27 Edition 3.0 Withdrawn and replaced
2011-03 Medical electrical with newer version
equipment--Part 2-27: including technical
Particular requirements for corrigendum.
the basic safety and
essential performance of
electrocardiographic
monitoring equipment
[Including: Corrigendum 1
(2012)].
----------------------------------------------------------------------------------------------------------------
D. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-92...................... .......................... ANSI/ADA Standard No. 88 Reaffirmation.
(Reaffirmed 2012) Dental
brazing alloys.
4-96...................... .......................... ANSI/ADA Specification No. 30 Reaffirmation.
(Reaffirmed 2010) Dental zinc
oxide--eugenol and zinc
oxide--non-eugenol cements.
4-97...................... .......................... ANSI/ADA Standard No. 57 Reaffirmation.
(Reaffirmed 2012) Endodontic
sealing materials.
4-149..................... .......................... ANSI/ADA Specification No. 39 Reaffirmation.
(Reaffirmed 2011) Pit and
fissure sealants.
4-160..................... .......................... ANSI S3.1 (Reaffirmed 2013) Reaffirmation.
Maximum permissible ambient
noise levels for audiometric
test rooms.
4-162..................... .......................... ANSI S3.4-2007 (Reaffirmed Reaffirmation.
2012) Procedure for the
computation of loudness of
steady sounds.
4-163..................... .......................... ANSI S3.5-1987 (Reaffirmed Reaffirmation.
2012) American national
standard methods for
calculation of the speech
intelligibility index.
4-165..................... .......................... ANSI S3.13-1987 (Reaffirmed Reaffirmation.
2012) American national
standard mechanical coupler
for measurement of bone
vibrators.
4-171..................... .......................... ANSI S3.37-1987 (Reaffirmed Reaffirmation.
2012) American national
standard preferred earhook
nozzle thread for
postauricular hearing aids.
4-175..................... 4-211..................... ANSI S3.46-2013 American Withdrawn and replaced
national standard method of with newer version.
measurement of real-ear
performance characteristics
of hearing aids.
4-177..................... .......................... ANSI S12.65-2006 (Reaffirmed Reaffirmation.
2011) American national
standard for rating noise
with respect to speech
interference.

[[Page 38913]]

4-179..................... 4-212..................... ISO 7405 Second edition 2008- Withdrawn and replaced
12-15 Dentistry--Evaluation with newer version
of biocompatibility of including amendment.
medical devices used in
dentistry [Including:
Amendment 1 (2013)].
4-193..................... .......................... ANSI/ADA Standard No. 15 Reaffirmation.
(Reaffirmed 2013) Artificial
teeth for dental prostheses.
----------------------------------------------------------------------------------------------------------------
E. General I (Quality Systems/Risk Management (QS/RM))
----------------------------------------------------------------------------------------------------------------
5-22...................... .......................... ISO 2768-l First edition 1999- Withdrawn.
11-15 General tolerances--
Part 1: Tolerances for linear
and angular dimensions
without individual tolerance
indications.
5-23...................... .......................... ISO 2768-2 First edition 1989- Withdrawn.
11-15 General tolerances--
Part 2: Geometrical
tolerances for features
without individual tolerance
indications.
5-50...................... 5-87...................... IEC 62366 Edition 1.1 2014-01 Withdrawn and replaced
Medical devices--Application with newer version.
of usability engineering to
medical devices.
5-53...................... 19-1...................... IEC 60601-1-2 Edition 3:2007- Transferred to General
03 Medical electrical II (ES/EMC).
equipment--Part 1-2: General
requirements for basic safety
and essential performance--
Collateral standard:
Electromagnetic
compatibility--Requirements
and tests.
5-54...................... 19-2...................... ANSI/AAMI/IEC 60601-1-2:2007/ Transferred to General
(R)2012 Medical electrical II (ES/EMC).
equipment--Part 1-2: General
requirements for basic safety
and essential performance--
Collateral standard:
Electromagnetic
compatibility--Requirements
and tests.
5-66...................... 19-3...................... IEC 60601-1-10 Edition 1.0 Transferred to General
2007-11 Medical electrical II (ES/EMC).
equipment--Part 1-10: General
requirements for basic safety
and essential performance--
Collateral standard:
Requirements for the
development of physiologic
closed-loop controllers.
5-77...................... 19-4...................... ANSI/AAMI ES60601-1:2005/ Transferred to General
(R)2012 and A1:2012,C1:2009/ II (ES/EMC).
(R)2012 and A2:2010/(R)2012
(consolidated text) Medical
electrical equipment--Part 1:
General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, mod).
5-78...................... 19-5...................... ANSI/AAMI ES60601-1:2005/ Transferred to General
(R)2012 and C1:2009/(R)2012 II (ES/EMC).
and A2:2010/(R)2012
(consolidated text) Medical
electrical equipment--Part 1:
General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, mod).
5-81...................... 5-88...................... ISO 2859-1 First edition 1999- Withdrawn and replaced
11-15 Sampling procedures for with newer version
inspection by attributes-- including amendment.
Part 1: Sampling schemes
indexed by acceptance quality
limit (AQL) for lot-by-lot
inspection [Including:
Corrigendum 1 (2001),
Amendment 1 (2011)].
5-82...................... 19-6...................... IEC 60601-1-11 Edition 1.0 Transferred to General
2010-04 Medical electrical II (ES/EMC).
equipment--Part 1-11: General
requirements for basic safety
and essential performance--
Collateral standard:
Requirements for medical
electrical equipment and
medical electrical systems
used in the home healthcare
environment [including:
Technical corrigendum 1
(2011)].
5-83...................... 19-7...................... ANSI/AAMI HA60601-1-11:2011 Transferred to General
Medical electrical equipment-- II (ES/EMC).
Part 1-11: General
requirements for basic safety
and essential performance--
Collateral standard:
Requirements for medical
electrical equipment and
medical electrical systems
used in the home healthcare
environment (IEC 60601-1-
11:2010 mod).
5-85...................... .......................... IEC 60601-1-6 Edition 3.0 2010- Transition period added.
01 Medical electrical
equipment--Part 1-6: General
requirements for basic safety
and essential performance--
Collateral standard:
Usability.
5-73...................... 5-90...................... ISO 15223-1 Second edition Extent of recognition.
2012-07-01 Medical devices--
Symbols to be used with
medical device labels,
labeling, and information to
be supplied--Part 1: General
requirements.
5-75...................... 5-91...................... AAMI/ANSI/ISO 15223-1:2012 Extent of recognition.
Medical devices--Symbols to
be used with medical devices
labels, labeling, and
information to be supplied--
Part 1: General requirements.
5-57...................... .......................... AAMI/ANSI HE75:2009 Human Relevant guidance.
factors engineering--Design
of medical devices.
5-67...................... .......................... ANSI/AAMI/IEC 62366:2007/ Relevant guidance.
(R)2013 Medical devices--
Application of usability
engineering to medical
devices.
----------------------------------------------------------------------------------------------------------------
F. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-180..................... .......................... ASTM F2407-06 (Reapproved Reaffirmation.
2013) Standard specification
for surgical gowns intended
for use in healthcare
facilities.

[[Page 38914]]

6-184..................... 6-323..................... ASTM F1862/F1862M-13 Standard Withdrawn and replaced
test method for resistance of with newer version.
medical face masks to
penetration by synthetic
blood (horizontal projection
of fixed volume at a known
velocity).
6-234..................... 6-324..................... IEC 60601-2-50 Edition 2.0 Withdrawn and replaced
2009-03 Medical electrical with newer version
equipment--Part 2-50: including technical
Particular requirements for corrigendum.
the basic safety and
essential performance of
infant phototherapy equipment
[Including: Technical
corrigendum 1 (2010)].
6-300..................... 6-325..................... IEC 60601-2-21 Edition 2.0 Withdrawn and replaced
2009-02 Medical electrical with newer version
equipment--Part 2-21: including technical
Particular requirements for corrigendum.
the basic safety and
essential performance of
infant radiant warmers
[Including: Technical
corrigendum 1 (2013)].
6-309..................... 6-326..................... USP 37-NF 33:2014 Sodium Withdrawn and replaced
chloride irrigation. with newer version.
6-310..................... 6-327..................... USP 37-NF 33:2014 Sodium Withdrawn and replaced
chloride injection. with newer version.
6-311..................... 6-328..................... USP 37-NF 33:2014 Withdrawn and replaced
Nonabsorbable surgical suture. with newer version.
6-312..................... 6-329..................... USP 37-NF 33:2014 <881> Withdrawn and replaced
Tensile strength. with newer version.
6-313..................... 6-330..................... USP 37-NF 33:2014 <861> Withdrawn and replaced
Sutures--Diameter. with newer version.
6-314..................... 6-331..................... USP 37-NF 33:2014 <871> Withdrawn and replaced
Sutures--Needle attachment. with newer version.
6-315..................... 6-332..................... USP 37-NF 33:2014 Sterile Withdrawn and replaced
water for irrigation. with newer version.
6-316..................... 6-333..................... USP 37-NF 33:2014 Heparin lock Withdrawn and replaced
flush solution. with newer version.
6-317..................... 6-334..................... USP 37-NF 33:2014 Absorbable Withdrawn and replaced
surgical suture. with newer version.
----------------------------------------------------------------------------------------------------------------
G. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-48...................... .......................... CLSI C60-A (Formerly T/DM06-A) Designation number.
Blood alcohol testing in the
clinical laboratory; Approved
guideline.
7-112..................... .......................... CLSI POCT14-A (Formerly H49-A) Designation number.
Point-of-care monitoring of
anticoagulation therapy;
Approved guideline.
7-133..................... 7-246..................... CLSI POCT12-A3 Point-of-care Withdrawn and replaced
blood glucose testing in with newer version.
acute and chronic care
facilities; Approved
guideline--Third edition.
7-142..................... .......................... CLSI GP43-A4 (Replaces H11-A4) Designation number.
Procedures for the collection
of arterial blood specimens;
Approved standard--Fourth
edition.
7-162..................... .......................... CLSI POCT14-A (Formerly H49-A) Designation number.
Point-of-care monitoring of
anticoagulation therapy;
Approved guideline.
7-175..................... .......................... CLSI C59-A (Formerly I/LA15-A) Designation number.
Apolipoprotein immunoassays:
Development and recommended
performance characteristics;
Approved guideline.
7-201..................... .......................... CLSI GP41-A6 (Replaces H03-A6) Designation number.
Procedures for the collection
of diagnostic blood specimens
by venipuncture; Approved
standard--Sixth edition.
7-203..................... .......................... CLSI GP42-A6 (Replaces H04-A6) Designation number.
Procedures and devices for
the collection of diagnostic
capillary blood specimens;
Approved standard--Sixth
edition.
7-213..................... .......................... CLSI GP44-A4 (Replaces H18-A4) Designation number.
Procedures for the handling
and processing of blood
specimens for common
laboratory tests; Approved
guideline--Fourth edition.
7-221..................... .......................... CLSI GP39-A6 (Replaces H01-A6) Designation number.
Tubes and additives for
venous and capillary blood
specimen collection; Approved
standard--Sixth edition.
7-241..................... 7-247..................... CLSI M100-S24 Performance Withdrawn and replaced
standards for antimicrobial with newer version.
susceptibility testing;
Twenty-fourth informational
supplement.
----------------------------------------------------------------------------------------------------------------
H. Materials
----------------------------------------------------------------------------------------------------------------
8-173..................... 8-371..................... ASTM F601-13 Standard practice Withdrawn and replaced
for fluorescent penetrant with newer version.
inspection of metallic
surgical implants.
8-183..................... 8-372..................... ASTM F560-13 Standard Withdrawn and replaced
specification for unalloyed with newer version.
tantalum for surgical implant
applications (UNS R05200, UNS
R05400).
8-193..................... .......................... ASTM F2754/F2754M-09 Reaffirmation.
(Reapproved 2013) Standard
test method for measurement
of camber, cast, helix, and
direction of helix of coiled
wire.

[[Page 38915]]

8-198..................... 8-373..................... ASTM F2102-13 Standard guide Withdrawn and replaced
for evaluating the extent of with newer version.
oxidation in polyethylene
fabricated forms intended for
surgical implants.
8-199..................... 8-374..................... ASTM F2633-13 Standard Withdrawn and replaced
specification for wrought with newer version.
seamless nickel-titanium
shape memory alloy tube for
medical devices and surgical
implants.
8-221..................... 8-375..................... ASTM F2066-13 Standard Withdrawn and replaced
specification for wrought with newer version.
titanium-15 molybdenum alloy
for surgical implant
applications (UNS R58150).
8-224..................... 8-376..................... ASTM F2102-13 Standard guide Withdrawn and replaced
for evaluating the extent of with newer version.
oxidation in polyethylene
fabricated forms intended for
surgical implants.
8-341..................... 8-377..................... ASTM F136-13 Standard Withdrawn and replaced
specification for wrought with newer version.
titanium-6aluminum-4vanadium
ELI (extra low interstitial)
alloy for surgical implant
applications (UNS R56401).
8-364..................... 8-378..................... ASTM D792-13 Standard test Withdrawn and replaced
methods for density and with newer version.
specific gravity (relative
density) of plastics by
displacement.
8-366..................... 8-379..................... ISO 11542-2 First edition 1998- Withdrawn and replaced
11-15 Plastics--Ultra-high- with newer version
molecular-weight polyethylene including technical
(PE-UHMW) moulding and corrigendum.
extrusion materials--Part 2:
Preparation of test specimens
and determination of
properties [Including:
Technical corrigendum 1
(2007)].
----------------------------------------------------------------------------------------------------------------
I. Nanotechnology
----------------------------------------------------------------------------------------------------------------
18-2...................... .......................... ASTM E2535-07 (Reapproved Reaffirmation.
2013) Standard guide for
handling unbound engineered
nanoscale particles in
occupational settings.
----------------------------------------------------------------------------------------------------------------
J. Neurology
----------------------------------------------------------------------------------------------------------------
17-10..................... .......................... ANSI/AAMI/ISO 14708-3:2008/ Reaffirmation.
(R)2011 Implants for surgery--
Active implantable medical
devices--Part 3: Implantable
neurostimulators.
----------------------------------------------------------------------------------------------------------------
K. OB-GYN/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-44...................... .......................... ASTM F623-99 (Reapproved 2013) Reaffirmation.
Standard performance
specification for Foley
catheter.
9-87...................... 9-93...................... ISO 25841 Second edition 2014- Withdrawn and replaced
01-15 Female condoms-- with newer version.
Requirements and test methods.
9-21...................... 9-94...................... ISO 8600-4 Second edition 2014- Withdrawn and replaced
03-15 Optics and optical with newer version.
instruments--Medical
endoscopes and certain
accessories--Part 4:
Determination of maximum
width of insertion portion.
----------------------------------------------------------------------------------------------------------------
L. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-211.................... 11-276.................... ASTM F1798-13 Standard test Withdrawn and replaced
method for evaluating the with newer version.
static and fatigue properties
of interconnection mechanisms
and subassemblies used in
spinal arthrodesis implants.
11-237.................... 11-277.................... ISO 7206-6 Second edition 2013- Withdrawn and replaced
11-15 Implants for surgery-- with newer version.
Partial and total hip joint
prostheses--Part 6: Endurance
properties testing and
performance requirements of
neck region of stemmed
femoral components.
11-255.................... 11-278.................... ASTM F1717-14 Standard test Withdrawn and replaced
methods for spinal implant with newer version.
constructs in a vertebrectomy
model.
----------------------------------------------------------------------------------------------------------------
M. Radiology
----------------------------------------------------------------------------------------------------------------
12-23..................... .......................... NEMA XR 10-1986 (R1992, R1998, Withdrawn.
R2003) Measurement of the
maximum symmetrical radiation
field from a rotating anode x-
ray tube used for medical
diagnosis.
12-24..................... .......................... NEMA XR 11-1993 (R1999) Test Withdrawn.
standard for determination of
the limiting spatial
resolution of x-ray image
intensifier systems.
12-25..................... .......................... NEMA XR 15-1991 (R1996, R2001) Withdrawn.
Test standard for the
determination of the visible
entrance field size of an x-
ray image intensifier system.
12-26..................... .......................... NEMA XR 16-1991 (R1996, R2001) Withdrawn.
Test standard for the
determination of the system
contrast ratio and the system
veiling glare index of an x-
ray image intensifier system.
12-27..................... .......................... NEMA XR 17-1993 (R1999) Test Withdrawn.
standard for the measurement
of the image signal
uniformity of an x-ray image
intensifier system.

[[Page 38916]]

12-28..................... .......................... NEMA XR 18-1993 (R1999) Test Withdrawn.
standard for the
determination of the radial
image distortion of an x-ray
image intensifier system.
12-29..................... .......................... NEMA XR 19-1993 (R1999) Withdrawn.
Electrical, thermal, and
loading characteristics of x-
ray tubes used for medical
diagnosis.
12-66..................... 12-271.................... AIUM MUS Medical ultrasound Withdrawn and replaced
safety, third edition. with newer version.
12-79..................... .......................... NEMA XR7-1995 (R2000) High- Withdrawn.
voltage x-ray cable
assemblies and receptacles.
12-80..................... .......................... NEMA XR 9-1984 (R1994, R2000) Withdrawn.
Power supply guidelines for x-
ray machines.
12-81..................... .......................... NEMA XR 13-1990 (R1995, R2000) Withdrawn.
Mechanical safety standard
for power driven motions of
electromedical equipment.
12-82..................... .......................... NEMA XR 14-1990 (R1995, R2000) Withdrawn.
Recommended practices for
load bearing mechanical
assemblies used in diagnostic
imaging.
12-100.................... .......................... NEMA UD 3-2004 (R2009) Withdrawn
Standard for real time
display of thermal and
mechanical acoustic output
indices on diagnostic
ultrasound equipment.
12-146.................... 12-272.................... IEC 60601-2-17 Edition 3.0 Withdrawn and replaced
2013-11 Medical electrical with newer version.
equipment--Part 2-17:
Particular requirements for
the basic safety and
essential performance of
automatically-controlled
brachytherapy afterloading
equipment.
12-168.................... 12-273.................... IEC 60825-1 Edition 2.0 2007- Withdrawn and replaced
03 Safety of laser products-- with newer version
Part 1: Equipment including technical
classification and corrigendum and
requirements [Including: interpretation sheets.
Technical corrigendum 1
(2008), interpretation sheet
1 (2007), interpretation
sheet 2 (2007)].
12-193.................... .......................... AIUM AOL 2008 Acoustic output Withdrawn.
labeling standard for
diagnostic ultrasound
equipment revision 1--A
standard for how
manufacturers should specify
acoustic output data.
12-194.................... .......................... ANSI/HPS N43.6-2007 (R2013) Reaffirmation.
Sealed radioactive sources--
Classification.
12-201.................... 12-274.................... IEC 60601-2-54 Edition 1.0 Withdrawn and replaced
2009-06 Medical electrical with newer version
equipment--Part 2-54: including technical
Particular requirements for corrigendum.
the basic safety and
essential performance of x-
ray equipment for radiography
and radioscopy [Including:
Technical corrigendum 1
(2010), technical corrigendum
2 (2011)].
12-220.................... .......................... IEC 60825-1 (Second edition- Withdrawn. See 12-273.
2007) Safety of laser
products--Part 1: Equipment
classification and
requirements corrigendum 1.
12-239.................... .......................... IEC 60825-1 (Second edition- Withdrawn. See 12-273.
2007) I-SH 01 Safety of laser
products--Part 1: Equipment
classification and
requirements, interpretation
sheet 1.
12-240.................... .......................... IEC 60825-1 (2007) Second Withdrawn. See 12-273.
edition, I-SH 02 Safety of
laser products--Part 1:
Equipment classification and
requirements, interpretation
sheet 2.
----------------------------------------------------------------------------------------------------------------
N. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-4...................... 13-65..................... ANSI/UL 1998 Third edition Withdrawn and replaced
2013 Standard for software in with newer version.
programmable components.
13-15..................... .......................... CLSI AUTO13-A2 Laboratory New designation number.
instruments and data
management systems: Design of
software user interfaces and
end-user software systems
validation, operation, and
monitoring; Approved
guideline--second edition.
13-46..................... .......................... ASTM F2761-09 (2013) Medical Reaffirmation.
devices and medical systems--
Essential safety requirements
for equipment comprising the
patient-centric integrated
clinical environment (ICE)--
Part 1: General requirements
and conceptual model.
13-58..................... 13-66..................... ISO/IEEE 11073-10417 First Withdrawn and replaced
edition 2014-03-01 Health with newer version.
informatics--Personal health
device communication--Part
10417: Device specialization:
Glucose meter.
----------------------------------------------------------------------------------------------------------------
O. Sterility
----------------------------------------------------------------------------------------------------------------
14-181.................... 14-432.................... ANSI/AAMI ST58:2013 Chemical Withdrawn and replaced
sterilization and high-level with newer version.
disinfection in health care
facilities.
14-228.................... .......................... ANSI/AAMI/ISO 11135-1:2007 Withdrawn. See 14-452.
Sterilization of healthcare
products--Ethylene oxide--
Part 1: Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.

[[Page 38917]]

14-232.................... 14-433.................... ASTM F2227-13 Standard test Withdrawn and replaced
method for non-destructive with newer version.
detection of leaks in non-
sealed and empty packaging
trays by CO2 tracer gas
method.
14-233.................... 14-434.................... ASTM F2228-13 Standard test Withdrawn and replaced
method for non-destructive with newer version.
detection of leaks in
packaging which incorporates
porous barrier material by
CO2 tracer gas method.
14-256.................... .......................... ASTM F2095-07 (Reapproved Reaffirmation.
2013) Standard test methods
for pressure decay leak test
for flexible packages with
and without restraining
plates.
14-257.................... .......................... ASTM D3078-02 (Reapproved Reaffirmation.
2013) Standard test method
for determination of leaks in
flexible packaging by bubble
emission.
14-259.................... 14-435.................... ASTM F2251-13 Standard test Withdrawn and replaced
method for thickness with newer version.
measurement of flexible
packaging material.
14-261.................... .......................... ANSI/AAMI/ISO 17665-1:2006/ Reaffirmation.
(R)2013 Sterilization of
health care products--Moist
heat--Part 1: Requirements
for the development,
validation, and routine
control of a sterilization
process for medical devices.
14-282.................... .......................... ASTM F2338-09 (Reapproved Reaffirmation.
2013) Standard test method
for nondestructive detection
of leaks in packages by
vacuum decay method.
14-286.................... .......................... ANSI/AAMI ST65:2008/(R)2013 Reaffirmation.
Processing of reusable
surgical textiles for use in
health care facilities.
14-288.................... .......................... ASTM F1886/F1886M-09 Reaffirmation.
(Reapproved 2013) Standard
test method for determining
integrity of seals for
flexible packaging by visual
inspection.
14-290.................... .......................... ANSI/AAMI ST24:1999/(R)2013 Reaffirmation.
Automatic, general purpose
ethylene oxide sterilizers
and ethylene oxide sterilant
sources intended for use in
health care facilities.
14-291.................... .......................... ANSI/AAMI/ISO 14937:2009/ Reaffirmation.
(R)2013 Sterilization of
healthcare products--General
requirements for
characterization of a
sterilizing agent and the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-331.................... 14-452.................... ISO 11135 Second edition 2014 Withdrawn and replaced
Sterilization of healthcare with newer version.
products--Ethylene oxide--
Requirements for the
development, validation, and
routine control of a
sterilization process for
medical devices.
14-342.................... .......................... ASTM E2628-09 (E2009) Standard Withdrawn. See 14-436.
practice for dosimetry in
radiation.
13-343.................... .......................... ASTM E2701-09 Standard guide Withdrawn. See 14-437.
for performance
characterization of
dosimeters and dosimetry
systems for use in radiation
processing.
14-348.................... .......................... ANSI/AAMI/ISO 13408-2:2003/ Reaffirmation.
(R)2013 Aseptic processing of
healthcare products--Part 2:
Filtration.
14-364.................... 14-438.................... ANSI/AAMI/ISO 11137-2:2013 Withdrawn and replaced
Sterilization of health care with newer version.
products--Radiation--Part 2:
Establishing the
sterilization dose.
14-394.................... 14-439.................... ANSI/AAMI ST79:2010, A1:2010, Withdrawn and replaced
A2:2011, A3:2012, and A4:2013 with newer version.
(consolidated text)
Comprehensive guide to steam
sterilization and sterility
assurance in health care
facilities.
14-414.................... 14-440.................... USP 37NF32:2014 Withdrawn and replaced
Microbiological examination with newer version.
of nonsterile products:
Microbial enumeration tests.
14-415.................... 14-441.................... USP 37NF32:2014 Sterility Withdrawn and replaced
tests. with newer version.
14-416.................... 14-442.................... USP 37NF32:2014 Bacterial Withdrawn and replaced
endotoxins test. with newer version.
14-417.................... 14-443.................... USP 37NF32:2014 Pyrogen test Withdrawn and replaced
(USP rabbit test). with newer version.
14-418.................... 14-444.................... USP 37NF32:2014 Transfusion Withdrawn and replaced
and infusion assemblies and with newer version.
similar medical devices.
14-419.................... 14-445.................... USP 37NF32:2014 Biological Withdrawn and replaced
indicator for steam with newer version.
sterilization--Self-contained.
14-420.................... 14-446.................... USP 37NF32:2014 Biological Withdrawn and replaced
indicator for dry-heat with newer version.
sterilization, paper carrier.
14-421.................... 14-447.................... USP 37NF32:2014 Biological Withdrawn and replaced
indicator for ethylene oxide with newer version.
sterilization, paper carrier.
14-422.................... 14-448.................... USP 37NF32:2014 Biological Withdrawn and replaced
indicator for steam with newer version.
sterilization, paper carrier.
14-423.................... 14-449.................... USP 37NF32:2014 Withdrawn and replaced
Microbiological examination with newer version.
of nonsterile products: Tests
for specified microorganisms.

[[Page 38918]]

14-425.................... .......................... ANSI/AAMI/ISO 13408-6:2005/ Reaffirmation.
(R)2013 and A1:2013 Aseptic
processing of healthcare
products--Part 6: Isolator
systems.
----------------------------------------------------------------------------------------------------------------
P. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-21..................... 15-39..................... ASTM F2150-13 Standard guide Withdrawn and replaced
for characterization and with newer version.
testing of biomaterial
scaffolds used in tissue-
engineered medical
products(TEMPs).
15-26..................... 15-40..................... ASTM F2211-13 Standard Withdrawn and replaced
classification for tissue- with newer version.
engineered medical products
(TEMPs).
15-33..................... 15-41..................... ASTM F2602-13 Standard test Withdrawn and replaced
method for determining the with newer version.
molar mass of chitosan and
chitosan salts by size
exclusion chromatography with
multi-angle light scattering
detection (SEC-MALS).
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

In table 2, we provide the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 036.

Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
Reference No.
Recognition No. Title of standard \1\ and date
------------------------------------------------------------------------
A. Cardiovascular
------------------------------------------------------------------------
3-127....................... Medical electrical ANSI/AAMI/IEC
equipment--Part 2-47: 60601-2-47:201
Particular requirements 2.
for the basic safety and
essential performance of
ambulatory
electrocardiographic
systems.
3-128....................... Active implantable ANSI/AAMI/ISO
medical devices-- 14117:2012.
Electromagnetic
compatibility--EMC test
protocols for
implantable cardiac
pacemakers, implantable
cardioverter
defibrillators, and
cardiac
resynchronization
devices.
------------------------------------------------------------------------
B. General I (Quality System/Risk Management (QS/RM))
------------------------------------------------------------------------
5-89........................ Medical electrical IEC 60601-1-6
equipment--Part 1-6: Edition 3.1
General requirements for 2013-10.
basic safety and
essential performance--
Collateral standard:
Usability.
5-92........................ Medical Electrical ANSI/AAMI/IEC
Equipment--Part 1-8: 60601-1-8:2006
General requirements for & A1:2012.
basic safety and
essential performance--
Collateral standard:
General requirements,
tests and guidance for
alarm systems in medical
electrical equipment and
medical electrical
systems.
------------------------------------------------------------------------
C. General II (Electrical Safety/Electromagnetic Compatibility (ES/EMC))
------------------------------------------------------------------------
19-1........................ Medical electrical IEC 60601-1-2
equipment--Part 1-2: Edition 3:2007-
General requirements for 03.
basic safety and
essential performance--
Collateral standard:
electromagnetic
compatibility--requireme
nts and tests.
19-2........................ Medical electrical ANSI/AAMI/IEC
equipment--Part 1-2: 60601-1-2:2007/
General requirements for (R)2012.
basic safety and
essential performance--
Collateral standard:
electromagnetic
compatibility--requireme
nts and tests.
19-3........................ Medical electrical IEC 60601-1-10
equipment--Part 1-10: Edition
General requirements for 1.0:2007-11.
basic safety and
essential performance--
Collateral standard:
requirements for the
development of
physiologic closed-loop
controllers.
19-4........................ Medical electrical ANSI/AAMI
equipment--Part 1: ES60601-1:2005/
General requirements for (R)2012 and
basic safety and A1:2012,C1:200
essential performance 9/(R)2012 and
(IEC 60601-1:2005, mod). A2:2010/
(R)2012.
19-5........................ Medical electrical ANSI/AAMI
equipment--Part 1: ES60601-1:2005/
General requirements for (R)2012 and
basic safety and C1:2009/
essential performance (R)2012 and,
(IEC 60601-1:2005, mod). A2:2010/
(R)2012
(Consolidated
text).
19-6........................ Medical electrical IEC 60601-1-11
equipment--Part 1-11: Edition
General requirements for 1.0:2010-04.
basic safety and
essential performance--
Collateral standard:
Requirements for medical
electrical equipment and
medical electrical
systems used in the home
healthcare environment
[Including: Technical
corrigendum 1 (2011)].
19-7........................ Medical electrical ANSI/AAMI
equipment--Part 1-11: HA60601-1-11:2
General requirements for 011.
basic safety and
essential performance--
Collateral standard:
Requirements for medical
electrical equipment and
medical electrical
systems used in the home
healthcare environment
(IEC 60601-1-11:2010
mod).

[[Page 38919]]

19-8........................ Medical electrical IEC 60601-1-2
equipment--Part 1-2: Edition
General requirements for 4.0:2014-02.
basic safety and
essential performance--
Collateral standard:
Electromagnetic
disturbances--Requiremen
ts and tests.
19-9........................ Medical electrical IEC 60601-1-10
equipment--Part 1-10: Edition
General requirements for 1.1:2013-11.
basic safety and
essential performance--
Collateral standard:
Requirements for the
development of
physiologic closed-loop
controllers.
19-10....................... Lithium batteries........ UL 1642 5th
Edition 2013.
19-11....................... Household and commercial UL 2054 2nd
batteries. Edition 2011.
------------------------------------------------------------------------
D. Orthopedics
------------------------------------------------------------------------
11-279...................... Standard practice for ASTM F2996-13.
finite element analysis
(FEA) of non-modular
metallic orthopaedic hip
femoral stems.
11-280...................... Standard test method for ASTM F2624-12.
static, dynamic, and
wear assessment of extra-
discal single level
spinal constructs.
------------------------------------------------------------------------
E. Radiology
------------------------------------------------------------------------
12-275...................... Ultrasonics--Power IEC 61161
measurement--Radiation Edition
force balances and 3.0:2013-01.
performance requirements.
12-276...................... Ultrasonics--Output test-- IEC TS 62462
Guide for the First edition
maintenance of 2007-05.
ultrasound physiotherapy
systems.
12-277...................... Ultrasonics--Hydrophones- IEC 62127-1
-Part 1: Measurement and Edition
characterization of 1.1:2013-02.
medical ultrasonic
fields up to 40
megahertz (MHz).
12-278...................... Ultrasonics--Hydrophones- IEC 62127-2
-Part 2: Calibration for Edition
ultrasonic fields up to 1.0:2007-08.
40 MHz (including
corrigendum 1:2008 and
amendment 1:2013).
12-279...................... Ultrasonics--Hydrophones- IEC 62127-3
-Part 3: Properties of Edition
hydrophones for 1.1:2013-05.
ultrasonic fields up to
40 MHz.
12-280...................... Ultrasonics--Power IEC 62555
measurement--High Edition
intensity therapeutic 1.0:2013-11.
ultrasound (HITU)
transducers and systems.
12-281...................... Medical electrical IEC 60601-2-62
equipment--Part 2-62: Edition
Particular requirements 1.0:2013-07.
for the basic safety and
essential performance of
high intensity
therapeutic ultrasound
(HITU) equipment.
12-282...................... Eyewear for protection ISO 12609-1
against intense light First edition
sources used on humans 2013-07-15.
and animals for cosmetic
and medical
applications--Part 1:
Specification for
products.
12-283...................... Eyewear for protection ISO 12609-2
against intense light First edition
sources used on humans 2013-07-15.
and animals for cosmetic
and medical
applications--Part 2:
Guidance for use.
------------------------------------------------------------------------
F. Software/Informatics
------------------------------------------------------------------------
13-67....................... Health informatics-- ISO/IEEE 11073-
Personal health device 10418 First
communication--Part edition 2014-
10418: Device 03-01.
specialization--Internat
ional normalized ratio
(INR) monitor.
13-68....................... Health informatics--Point- ISO 11073-90101
of-care medical device First edition
communication--Part 2008-01-15.
90101: Analytical
instruments--Point-of-
care test.
13-69....................... Health Informatics-- ISO/IEEE 11073-
Personal health device 10472 First
communication--Part edition 2012-
10472: Device 11-01.
specialization--Medicati
on monitor.
------------------------------------------------------------------------
G. Sterility
------------------------------------------------------------------------
14-436...................... Practice for dosimetry in ISO/ASTM 52628
radiation processing. First edition
2013-11-15.
14-437...................... Guide for performance ISO/ASTM 52701
characterization of First edition
dosimeters and dosimetry 2013-11-15.
systems for use in
radiation processing.
14-450...................... Biological indicators-- USP 37-
Resistance performance NF32:2014
tests. <55>.
14-451...................... Biological indicators for USP 37-
sterilization. NF32:2014
<1035>.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
of the respective organizations.

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 our
Internet site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. We will incorporate the modifications and
revisions described in this notice into the database and, upon
publication in the Federal Register, this recognition of consensus
standards will be effective. We will announce additional modifications
and revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with Recognition List 033, we will no longer announce minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

Any person may recommend consensus standards as candidates for

[[Page 38920]]

recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
www.standards@cdrh.fda.gov. 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. The Center for Devices and
Radiological Health (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: 036'' will be available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You
may access the CDRH home page at https://www.fda.gov/MedicalDevices.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

VII. Submission of Comments and Effective Date

Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. 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: 036. These
modifications to the list of recognized standards are effective upon
publication of this notice in the Federal Register.

Dated: July 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15989 Filed 7-8-14; 8:45 am]
BILLING CODE 4164-01-P

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