AAMI Standards Monitor Online 10 December 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 completed transitioning our standards groups to the NEW AAMI Committee Central platform! Information is available here.
NEW! The second session of the new AAMI Standards Insider webinar series was held on Thursday, November 18th 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, February 17th, 2022 from 1:00-2:00 PM ET.
PUBLISHED! ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
PUBLISHED! ANSI AAMI SW96:2021, Standard for medical device security — Security risk management for device manufacturers
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 December 31, 2021
AAMI/ISO 17664-1, Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (identical national adoption of ISO 17664-1 and revision of ANSI/AAMI/ISO 17664-2017) Specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires sterilization or disinfection to ensure that the device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the medical device. Applicable for medical devices that are intended for invasive or other direct patient contact or that otherwise present the risk of transmission of infectious agents. Processing instructions are not defined in this standard. Rather, this International Standard specifies requirements to assist manufacturers of medical devices in providing detailed instructions for processing that consists of the following activities where applicable: pre-treatment at the point of use; preparation, cleaning, disinfection; drying; inspection, maintenance and testing; packaging; sterilization; storage; transportation. Contact: Amanda Benedict
AAMI/ISO 17664-2, Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (identical national adoption of ISO 17664-2 and revision of ANSI/AAMI/ISO 17664-2017) Specifies requirements for the information to be provided by the medical device manufacturer for the processing of medical devices not intended for direct patient contact. This includes information for processing prior to use or reuse of the medical device. Contact: Amanda Benedict
AAMI 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 SM-WG09 – Cloud Computing WG. 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 CR 510:2021, 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. 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. The kickoff meeting for AAMI TIR112, Guidance for closed system transfer device testing with hazardous drugs was held on September 21st and was a success. The committee is seeking user, regulatory and general interest members to participate in the development of 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.
December 2021
Steam sterilization hospital practices working group (open meeting), 10 December 2021, 13:00 h to 16:00 h ET, web meeting. Contact: Amanda Benedict
Steam sterilization hospital practices working group (open meeting), 13 December 2021, 11:00 h to 14:00 h ET, web meeting. Contact: Amanda Benedict
Sphygmomanometer committee (open meeting), 14 December 2021, 16:00 h to 17:30 h ET, web meeting. Contact: Ladan Bulookbashi
Lens removal and vitrectomy devices working group (open meeting), 16 December 2021, 14:00 h to 16:00 h ET, web meeting. Contact: Ladan Bulookbashi
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.
December 2021
ISO/TC 198/WG 16, Vaporized hydrogen peroxide sterilization (closed meeting), 14 December 2021, 06:00 h to 08:00 h MST, Zoom meeting. Contact: Amanda Benedict
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.