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AMERICAN NATIONAL STANDARDS INSTITUTE 25 West 43Rd Street, NY, NY 10036 PUBLISHED WEEKLY BY THE AMERICAN NATIONAL STANDARDS INSTITUTE 25 West 43rd Street, NY, NY 10036 VOL. 47, #50 December 9, 2016 Contents American National Standards Call for Comment on Standards Proposals ................................................. 2 Call for Members (ANS Consensus Bodies) ................................................ 7 Final Actions .................................................................................................. 10 Project Initiation Notification System (PINS) ............................................... 12 ANS Maintained Under Continuous Maintenance ....................................... 15 ANSI-Accredited Standards Developers Contact Information ................... 16 Announcement of Proposed Procedural Revisions ..................................... 17 International Standards ISO and IEC Draft Standards ......................................................................... 18 ISO and IEC Newly Published Standards ..................................................... 21 Proposed Foreign Government Regulations ................................................. 23 Information Concerning .................................................................................. 24 Standards Action Publishing Schedule for 2017 .......................................... 34 American National Standards Call for comment on proposals listed This section solicits public comments on proposed draft new Ordering Instructions for "Call-for-Comment" Listings American National Standards, including the national adoption of 1. Order from the organization indicated for the specific ISO and IEC standards as American National Standards, and on proposal. proposals to revise, reaffirm or withdraw approval of existing 2. Use the full identification in your order, including the American National Standards. A draft standard is listed in this BSR prefix; for example, Electric Fuses BSR/SAE J554. section under the ANSI-accredited standards developer (ASD) that sponsors it and from whom a copy may be obtained. 3. Include remittance with all orders. Comments in connection with a draft American National 4. BSR proposals will not be available after the deadline of Standard must be submitted in writing to the ASD no later than call for comment. the last day of the comment period specified herein. Such comments shall be specific to the section(s) of the standard Comments should be addressed to the organization indicated, under review and include sufficient detail so as to enable the with a copy to the Board of Standards Review, American reader to understand the commenter's position, concerns and National Standards Institute, 25 West 43rd Street, New York, suggested alternative language, if appropriate. Please note that NY 10036. Fax: 212-840-2298; e-mail: [email protected] the ANSI Executive Standards Council (ExSC) has determined that an ASD has the right to require that interested parties submit * Standard for consumer products public review comments electronically, in accordance with the developer’s procedures. © 2016 by American National Standards Institute, Inc. ISSN 0038-9633 ANSI members may reproduce for internal distribution. Journals may excerpt items in their fields Standards Action - December 9, 2016 - Page 2 of 35 pages Comment Deadline: January 8, 2017 AAMI (Association for the Advancement of Medical Instrumentation) UL (Underwriters Laboratories, Inc.) New National Adoption Revision BSR/AAMI/ISO 11138-2-201x, Sterilization of health care products - BSR/UL 13-201X, Standard for Safety for Power-Limited Circuit Cables Biological indicators - Part 2: Biological indicators for ethylene oxide (Proposal dated 12/9/16) (revision of ANSI/UL 13-2015a) sterilization processes (identical national adoption of ISO/FDIS 11138-2 and (1) Addition of stainless steel as a welded and corrugated metal sheath. (2) revision of ANSI/AAMI/ISO 11138-2-2006 (R2015)) Addition of -LP ratings. Provides specific requirements for test organisms, suspensions, inoculated Click here to view these changes in full carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene Send comments (with copy to [email protected]) to: Linda Phinney, (510) 319 oxide gas as the sterilizing agent, either as pure ethylene oxide gas or -4297, [email protected] mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29°C to 65°C. Single copy price: Free UL (Underwriters Laboratories, Inc.) Obtain an electronic copy from: https://standards.aami. org/kws/public/document?document_id=7035&wg_abbrev=PUBLIC_REV Revision Order from: Cliff Bernier, (703) 253-8263, [email protected] BSR/UL 295-201x, Standard for Safety for Commercial-Industrial Gas Burners (revision of ANSI/UL 295-2014) Send comments (with copy to [email protected]) to: Same The following topic is being recirculated: (1) Addition of requirements for gas assist (pre-mix) burners. Click here to view these changes in full AAMI (Association for the Advancement of Medical Send comments (with copy to [email protected]) to: Marcia Kawate, (510) 319 Instrumentation) -4259, [email protected] New National Adoption BSR/AAMI/ISO 11138-3-201x, Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization UL (Underwriters Laboratories, Inc.) processes (identical national adoption of ISO/FDIS 11138-3 and revision of ANSI/AAMI/ISO 11138-3-2006 (R2015)) Revision Provides specific requirements for test organisms, suspensions, inoculated BSR/UL 296-201x, Standard for Safety for Oil Burners (revision of ANSI/UL carriers, biological indicators, and test methods intended for use in 296-2011 (R2015)) assessing the performance of sterilization processes employing moist heat The following topic is being recirculated: (1) Revise requirements for as the sterilizing agent. programming and timings for burners. Single copy price: Free Click here to view these changes in full Obtain an electronic copy from: https://standards.aami. Send comments (with copy to [email protected]) to: Marcia Kawate, (510) 319 org/kws/public/document?document_id=7036&wg_abbrev=PUBLIC_REV -4259, [email protected] Order from: Cliff Bernier, (703) 253-8263, [email protected] Send comments (with copy to [email protected]) to: Same Comment Deadline: January 23, 2017 AAMI (Association for the Advancement of Medical Instrumentation) AAMI (Association for the Advancement of Medical New National Adoption Instrumentation) BSR/AAMI/ISO 11138-4-201x, Sterilization of health care products - New National Adoption Biological indicators - Part 4: Biological indicators for dry heat sterilization BSR/AAMI/ISO 11138-1-201x, Sterilization of health care products - processes (identical national adoption of ISO/FDIS 11138-4 and revision of Biological indicators - Part 1: General requirements (identical national ANSI/AAMI/ISO 11138-4-2006 (R2015)) adoption of ISO/FDIS 11138-1 and revision of ANSI/AAMI/ISO 11138-1 Provides specific requirements for test organisms, suspensions, inoculated -2006 (R2015)) carriers, biological indicators, and test methods intended for use in Provides general requirements for production, labeling, test methods and assessing the performance of sterilization processes employing dry heat as performance characteristics of biological indicators, including inoculated the sterilizing agent at sterilizing temperatures within the range of 120°C to carriers and suspensions, and their components, to be used in the validation 180°C. and routine monitoring of sterilization processes. Single copy price: Free Single copy price: Free Obtain an electronic copy from: http://my.aami.org/store/SearchResults. Obtain an electronic copy from: https://standards.aami. aspx?searchterm=11138-4&searchoption=ALL org/kws/public/document?document_id=7034&wg_abbrev=PUBLIC_REV Order from: Cliff Bernier, (703) 253-8263, [email protected] Order from: Cliff Bernier, (703) 253-8263, [email protected] Send comments (with copy to [email protected]) to: Same Send comments (with copy to [email protected]) to: Same Standards Action - December 9, 2016 - Page 3 of 35 pages AAMI (Association for the Advancement of Medical ASABE (American Society of Agricultural and Biological Instrumentation) Engineers) New National Adoption Reaffirmation BSR/AAMI/ISO 11138-5-201x, Sterilization of health care products - BSR/ASABE AD4254-11-2012 (R201x), Agricultural machinery - Safety - Biological indicators - Part 5: Biological indicators for low-temperature steam Part 11: Pick-up balers (reaffirmation of ANSI/ASABE AD4254-11-2012) and formaldehyde sterilization processes (identical national adoption of Specifies the safety requirements and their verification for the design and ISO/FDIS 11138-5 and revision of ANSI/AAMI/ISO 11138-5-2006 (R2015)) construction of self-propelled and trailed pick-up balers, including the Provides specific requirements for test organisms, suspensions, inoculated combination of pick-up balers with wrappers, independent of the shape or carriers, biological indicators and test methods intended for use in assessing size of the bales formed. It describes methods for the elimination or the performance of sterilization processes employing low-temperature steam reduction of hazards arising from the intended use and reasonably and formaldehyde as the sterilizing agent. foreseeable misuse of these machines by one person (the operator) in the Single copy price: Free course of normal operation and service. In addition,
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