AAMI Standards Monitor Online 6 August 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! AAMI Standards will be hosting periodic webinars starting in September 2021 to provide updates on activity across our standards development programs. More information coming soon.
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 August 16, 2021
AAMI ST8, Hospital steam sterilizers (revision of an American National Standard). Applies to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (L) (2 cubic feet [ft3]). Contact: Cliff Bernier
AAMI ST55, Table-top steam sterilizers (reaffirmation of an American National Standard). Establishes minimum construction and performance requirements for small tabletop steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 56.63 liters (2 cubic feet). Contact: Cliff Bernier
AAMI/ISO 5840-1, Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (identical national adoption of ISO 5840-1:2021 and revision of ANSI/AAMI/ISO 5840-1-2015). Applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. Applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. Contact: Cliff Bernier
AAMI/ISO 5840-2, Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (identical national adoption of ISO 5840-2:2021 and revision of ANSI/AAMI/ISO 5840-2-2015). Applicable to heart valve substitutes intended for implantation in human hearts, generally requiring cardiopulmonary bypass and generally with direct visualization. Applicable to both newly developed and modified surgical heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the surgical heart valve substitute to be implanted. Contact: Cliff Bernier
ISO 5840-3, Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (identical national adoption of ISO 5840-3:2021 and revision of ANSI/AAMI/ISO 5840-3-2012). Applicable to all devices intended for implantation as a transcatheter heart valve substitute. Applicable to transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. Contact: Cliff Bernier
AAMI/ISO 25539-2, Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (identical national adoption of ISO 25539-2:2020 and revision of ANSI/AAMI/ISO 25539-2-2012). Specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included. Contact: Cliff Bernier
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 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: 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. 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.
August 2021
Luer activated valves working group (open meeting). 16 August 2021, 15:00h to 17:00h ET. Virtual meeting. Contact: Colleen Elliott
Cleaning of reusable medical devices Working Group (open meetings). 18 and 25 August 2021, 14:00h to 17:00h ET. Virtual meetings. Contact: Jody Allen
EMC Test Protocols for Pacemakers, ICDs & CRTs Working Group (open meeting). 24 August 2021, 13:00h to 15:00h ET. Virtual meetings. Contact: Ladan Bulookbashi
September 2021
AAMI September 2021 Sterilization Standards Week (open meetings - advance registration REQUIRED). 13-16 September 2021, 08:00h to 17:30h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: sterilization@aami.org
Sterilization Standards Week opening plenary (open meetings - advance registration REQUIRED). 13 September 2021, 09:00h to 11:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: sterilization@aami.org
Steam sterilization hospital practices Working Group (open meeting - advance registration REQUIRED). 13 September 2021, 13:00h to 17:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Amanda Benedict
Industrial EO sterilization Working Group (open meeting - advance registration REQUIRED). 13 September 2021, 13:00h to 17:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Amanda Benedict
Cleaning of reusable medical devices Working Group (open meeting - advance registration REQUIRED). 13 September 2021, 13:00h to 17:00h ET and 16 September 2021, 08:00h to 12:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Jody Allen
Radiation sterilization Working Group (open meeting - advance registration REQUIRED). 14 September 2021, 08:00h to 12:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Amanda Benedict
Hospital EO sterilizer Working Group (open meeting - advance registration REQUIRED). 14 September 2021, 08:00h to 12:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Cliff Bernier
Endoscope reprocessing Working Group (open meeting - advance registration REQUIRED). 14 September 2021, 08:00h to 12:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Jody Allen
Packaging Working Group (open meeting - advance registration REQUIRED). 14 September 2021, 13:00h to 17:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Amanda Benedict
Chemical sterilants hospital practices Working Group (open meeting - advance registration REQUIRED). 14 September 2021, 13:00h to 17:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Jody Allen
Microbiological methods Working Group (open meeting - advance registration REQUIRED). 14 September 2021, 13:00h to 17:00h ET and 15 September 2021, 08:00h to 12:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Amanda Benedict
Vaporized hydrogen peroxide sterilization Working Group (open meeting - advance registration REQUIRED). 15 September 2021, 09:00h to 17:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Amanda Benedict
Water quality for reprocessing of reusable medical devices Working Group (open meeting - advance registration REQUIRED). 15 September 2021, 09:00h to 17:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Jody Allen
Compatibility of materials subject to sterilization Working Group (open meeting - advance registration REQUIRED). 15 September 2021, 13:00h to 17:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Cliff Bernier
Steam sterilization dental practices Working Group (open meeting - advance registration REQUIRED). 16 September 2021, 09:00h to 12:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Amanda Benedict
Protective Barriers Committee (open meeting - advance registration REQUIRED). 16 September 2021, 08:00h to 12:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). Contact: Darren Robertson
Sterilization Standards Week closing plenary and US TAG to ISO/TC 198 meeting (open meeting - advance registration REQUIRED). 16 September 2021, 13:00h to 15:00h ET. Virtual and AAMI, Arlington, VA (limited in-person attendance). 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
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.
August 2021
ISO/TC 198/WG 8, Microbiological methods (closed meetings), 24/26/28 August 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 13, Washer-disinfectors (closed meeting), 26 August 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
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 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 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.