AAMI Standards Monitor Online 28 March 2022
Standards Monitor Online (SMO) is a free subscription service that is delivered to your email every three weeks. This AAMI resource keeps you up to date with standards-related activities:
NEW! We have completed transitioning our standards groups to the NEW AAMI Committee Central platform! Information is available here.
PUBLISHED! ANSI/AAMI ES60601-1: 2005/A2:2021, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, Amendment 2 is available here.
PUBLISHED! ANSI/AAMI/IEC 60601-1-2:2014/A1:2021, Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, Amendment 1 is available here.
PUBLISHED! ANSI/AAMI/IEC 60601-1-8:2006/A2:2021, 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, Amendment 2 is available here.
PUBLISHED! ANSI/AAMI HA60601-1-11:2015/A1:2021, 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, Amendment 1 is available here.
PUBLISHED! ANSI/AAMI/IEC 60601-1-12:2016/A1:2021, Medical electrical equipment – Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment, Amendment 1 is available here.
The AAMI Standards Insider webinar series was last held on Thursday, February 24th from 1:00-2:00 PM ET. This one-hour FREE webinar provided news and updates about AAMI’s standards program and portfolio. The next webinar will be held on Thursday, May 19th 2022, from 1:00-2:00 PM ET. Register here.
If you would like to comment on one of the draft documents listed below, contact the individual indicated by e-mail to receive a PDF copy of the draft. These copies are free.
Published documents proposed for reaffirmation can be purchased from the AAMI Store.
AAMI CDV-1 ST108, Water for the processing of medical devices (proposed new American National Standard). Covers the selection and maintenance of effective water quality suitable for processing 26 medical devices. It provides guidelines for selecting the water quality necessary for the processing 27 of categories of medical devices and addresses water treatment equipment, water distribution and 28 storage, quality control procedures for monitoring water quality, strategies for bacterial control, 29 and environmental and personnel considerations. Contact: Jody Allen
AAMI/ISO CDV-1 11138-8, Sterilization of health care products – Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (identical national adoption of ISO 11138-8:2021). Specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. Contact: Jody Allen
AAMI/ISO CDV-1 15223-1, Medical devices– Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (identical national adoption of ISO 15223-1:2021, to supersede ANSI/AAMI/ISO 15223-1:2016). Specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards. Contact: Amanda Benedict
AAMI CN, Small-bore connectors Committee. This committee is working on the development of AAMI/ISO 80369-6/Ed.2, Small-bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications. This part of 80369 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes. Contact: Colleen Elliott
AAMI EQ, Medical Equipment Management Committee. The committee is working on the development of AAMI EQ110/Ed.1, Guidance for health care technology management education programs. This standard seeks to provide a recommended framework for new or established education programs in health care technology management (HTM). Contact: Jody Allen
AAMI SM-WG10, Cloud Computing. The AAMI Standards Board has approved the formation of a new working group under AAMI SM, Software and Information Technology, and authorized the group to begin work on a Technical Information Report based on the approved AAMI CR510:2021, Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices. This new WG is seeking members from the General interest, Industry, Regulatory and User categories to join.
Contact: Ovidiu Munteanu
AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use Committee. The committee has recently approved development of a new AAMI Technical Information Report (TIR) on Guidance for Closed System Transfer Device Testing with Hazardous Drugs. This TIR seeks to provide guidelines for physical and chemical compatibility of the drug with the Closed System Transfer Device (CSTD), which may include but not limited to holdup volume, coring/fragmentation of the vial rubber stopper, microbial ingress, stability/shelf-life, and usability. TIB-WG04 is in the process of appointing cochairs and is seeking user, regulatory and general interest members to participate in the development of AAMI TIR112. Contact: Sam Alameda
The committees listed below are seeking new members in the indicated stakeholder interest category to participate in the development of their documents. Definitions of the various stakeholder groups are:
An individual or organizational representative, who purchases, utilizes or receives the materials, products, systems, or services covered in the scope of technical documents developed by AAMI in the delivery of healthcare; individuals in this interest category include clinicians, employees or representatives of Healthcare Delivery Organizations, clinical consultants, patients, etc
An individual or organizational representative involved in the commercial production, promotion, sale, use or distribution of materials, products, systems, or services covered in the scope of technical documents developed by AAMI; this interest category includes manufacturers, those involved in supply chains, employees of test labs or commercial labs, industry consultants, etc.
An individual or organizational representative involved in the regulation of the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI; this interest category includes those representing federal, state, local, foreign, or other government entities
An individual or organizational representative with a general material interest in the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI and who does not fit into any of the preceding categories; this interest category can include noncommercial academicians, noncommercial researchers, patient or consumer advocates, representatives of accrediting organizations, representatives of other organizations, etc.
Please contact the staff person indicated for more information on how to join.
AAMI Committees and U.S. TAGs
Open meetings of AAMI committees and U.S. Technical Advisory Groups (TAGs) are listed here and at the AAMI website (www.aami.org). Note: If you plan to attend a meeting, please send a brief note to the
AAMI Standards Department (standards@aami.org) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
March 2022
AAMI Spring 2022 Sterilization Standards Week (open meetings – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28-31 March 2022, 08:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG84, Endoscope reprocessing (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG96, Compatibility of materials subject to sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG08, Microbiological methods (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28 March 2022, 13:00h to 17:00h ET and 29 March 2022, 08:00h to 12:00h ET, Arlington, VA and web meetings.
Contact: sterilization@aami.org
AAMI ST-WG40, Steam sterilization hospital practices (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 29 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG95, Water quality for reprocessing medical devices (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 29 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG02, Radiation sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 29 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG43, Hospital steam sterilizers (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 08:00h to 12:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG01, Industrial EO sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG61, Chemical sterilants hospital practices (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI Protective Barriers Committee (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG62, Hospital EO sterilizers (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 31 March 2022, 08:00h to 12:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG03, Industrial moist heat sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 31 March 2022, 10:00h to 12:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
US TAG to ISO/TC 198 (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 31 March 2022, 13:00h to 15:00h ET, Arlington, VA and web meeting. Contact: sterilization@aami.org
April 2022
AAMI ST-WG44, Steam sterilization dental practices (open meeting). 1 April 2022, 09:00h to 13:00h ET, web meeting. Contact: Amanda Benedict
AAMI Sphygmomanometer Committee (open meeting). 4 April 2022, 11:00h to 12:00h ET, web meeting. Contact: Ladan Bulookbashi
US TAGs to ISO/TC 121 and ISO/TC 121 SCs (AAMI AR and AR-WGs, Anaesthetic and respiratory equipment), (open meeting), 27 April, 16:00h to 17:00h EDT, web meeting. Contact: Colleen Elliott
May 2022
AAMI RD, Renal Disease and Detoxification Committee (open meeting – advance registration REQUIRED). 3 May 2022, 09:00h to 17:00h ET, Arlington, VA and web meeting. Contact: Jill Zajac
Information on draft international standards under ballot can be found in ANSI Standards Action.
International Committee and Working Group MeetingsCall or email the indicated staff person at AAMI for more information about upcoming international standards meetings.
March 2022
ISO/TC 210/WG 7, Good engineering maintenance management (closed meeting), 7 March 2022, 20:00h to 22:30h MYT, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 13, Washer-disinfectors (closed meeting), 10 March 2022, 08:00h to 11:00h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 29 March 2022, 13:00h to 16:00h GMT, Zoom meeting. Contact: Amanda Benedict
April 2022
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care (closed meeting), 14 April 2022, 17:00h to 19:00h EDT. Contact: Colleen Elliott
May 2022
ISO/TC 121/WG3, Cybersecurity for anaesthetic and respiratory equipment (closed meeting), 4 May, 10:00h – 12:00h EDT, virtual meeting. Contact: Colleen Elliott
July 2022
ISO/TC 121, Anaesthetic and respiratory equipment and affiliated groups (closed meetings), 11 to 15 July 2022, St. John’s, Newfoundland, Canada. Contact: Colleen Elliott
AAMI, in collaboration with the British Standards Institution, is launching an effort to develop standards for artificial intelligence (AI) and machine learning (ML) in medical technologies. In May of this year, AAMI published a whitepaper discussing the need for new standards and regulator initiatives to promote the safety, effectiveness, and availability of AI and ML in healthcare. (https://www.aami.org/detail-pages/press-release/aami-bsi-position-paper-sets-machine-learning-agenda)
There were seven recommendations made in the whitepaper. One of the most urgent was for guidance on applying ISO 14971, Medical Devices—Application of Risk Management to Medical Devices, when evaluating medical technology utilizing AI and, in particular, ML. AAMI and BSI have established a partnership to jointly develop a document which provides this guidance, as well as other needed AI standards identified in the whitepaper.
As a result of this initial work, AAMI is creating a new consensus body, tentatively call the AAMI Artificial Intelligence Committee (AAMI AI) to develop this work. Interested parties, including representatives of clinical practices, academia, regulatory authorities, and industry should contact standards@aami.org for more information about the project or participation on the committee.