AAMI Standards Monitor Online 17 September 2021
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 begun transitioning to the NEW AAMI Committee Central platform! Information is available here.
NEW! Please join the AAMI Standards team on Thursday, September 23 from 1:00-2:00 PM ET for the inaugural session of the new AAMI Standards Insider webinar series. This one-hour FREE webinar is intended to provide news and updates about AAMI’s standards program and portfolio. Please join us for introductions to the AAMI Standards staff, information about the migration of AAMI committees to the NEW AAMI Committee Central platform, and highlights and news from across AAMI’s standardization activities. Registration for the event is 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.
Comments due September 20, 2021
AAMI/ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices (reaffirmation of an American National Standard). Specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. Applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. Intended to be applied by process developers, manufacturers of sterilization equipment, manufacturers of products to be sterilized and organizations responsible for sterilizing medical devices. Purchase from: AAMI Store
AAMI PB70, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (revision of an American National Standard). Establishes minimum barrier performance requirements, a classification system, and associated labeling requirements for protective apparel, surgical drapes, and drape accessories intended for use in health care facilities. Contact: Darren RobertsonAAMI CN, Small bore connectors Committee. The committee is seeking user, regulatory and general interest members to participate in the development of AAMI/ISO 80369-1/Ed.3, Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements. Contact: Colleen Elliott
AAMI EQ, Medical bore connectors Committee. The committee is seeking user, regulatory and general interest members to participate in the development of AAMI/ISO 80369-1/Ed.3, Small-bore connectors for liquids and gases in healthcare applications framework for new or established education programs in health care technology management (HTM). Contact: Ovidiu Munteanu
AAMI QM-WG01, Application of Quality Systems to Medical Devices Working Group. The working group is working on the development of AAMI CR510, Consensus Report on Compliant Use of Cloud Computing for Quality Systems and Medical Devices. This Consensus Report will provide guidance to multiple stakeholders regarding the appropriate and compliant use of cloud computing both as a component of medical devices and in support of quality systems. Contact: Joe Lewelling
AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. The committee has recently approved development of an AAMI Technical Information Report (TIR), 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 Close 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. TBN131_Agenda for the 21 September 2021 web meeting of AAMI TIB - kickoff meeting for AAMI TIR112, Guidance for closed system transfer device testing with hazardous drugs was posted to AAMI committee central. The kickoff meeting will be held on September 21st, 1:00 to 3:00 pm ET, via Microsoft Teams. 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.
September 2021
AAMI TIB Committee/U.S. TAG to ISO/TC 76 (open meeting). 21 September 2021, 13:00h to 15:00h ET. Virtual. Contact: Sam Alameda
Chemical indicators Working Group (open meeting). 22 September 2021, 09:00h to 12:00h ET. Virtual. Contact: Amanda Benedict
Assurance of sterility Working Group (open meeting). 23 September 2021, 15:00h to 16:00h ET. Virtual. Contact: Amanda Benedict
Industrial EO sterilization Working Group (open meeting). 27 September 2021, 13:00h to 17:00h ET. Virtual. Contact: Amanda Benedict
Anaesthetic and respiratory equipment committee and affiliated working groups (open meeting). 29 September, 16:00h to 17:00h ET. Virtual. Contact: Colleen Elliott
October 2021
Multiparameter Patient Monitoring Equipment Committee (open meeting). 08 October 2021, 13:00h to 15:00h ET. Virtual. Contact: Ladan Bulookbashi
Radiation Sterilization Working Group (open meeting). 12 October 2021, 13:00h to 14:00h ET. Virtual. Contact: Amanda Benedict
November 2021
AAMI Renal Disease and Detoxification Committee (open meeting). 9 November 2021. Virtual. Contact: Cliff Bernier
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.
September 2021
ISO/TC 150/SC 2/WG 1, Cardiac valves (closed meeting). 20 September to 23 September 2021. Zoom meeting. Contact: Cliff Bernier
ISO/TC 150/SC 2/WG 5, Renal replacement, detoxification, and apheresis (closed meeting). 20 September to 24 September 2021. Zoom meeting. Contact: Cliff Bernier
ISO/TC 150/SC 2/WG 6, Vascular device-drug combination products (closed meeting). 21 September to 24 September 2021. Zoom meeting. Contact: Cliff Bernier
ISO/TC 198/WG 13, Washer-disinfectors (closed meeting), 28 September 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
October 2021
ISO/TC 198/WG 2, Radiation sterilization (closed meeting), 4 October 2021, 11:00 h to 12:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 19 October 2021, 13:00 h to 16:00 h IST, Zoom meeting. Contact: Amanda Benedict
November 2021
ISO/TC 198/WG 7, Packaging (closed meeting), 8/9 November 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198, Sterilization of health care products (closed meeting), 10 November 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 16 November 2021, 13:00 h to 16:00 h GMT, Zoom meeting. Contact: Amanda Benedict
December 2021
ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 14 December 2021, 13:00 h to 16:00 h GMT, Zoom meeting. Contact: Amanda Benedict
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.