AAMI Standards Monitor Online 19 May 2023
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:
PUBLISHED! AAMI TIR45:2023 Guidance on the use of AGILE practices in the development of medical device software. Click here for more information.
REAFFIRMED! AAMI TIR57:2016/(R)2023 Principles for medical device security—Risk management. Click here for more information.
REAFFIRMED! AAMI TIR97:2019/(R)2023 Principles for medical device security—Postmarket risk management for device manufacturers. Click here for more information.
The next AAMI Standards Insider webinar will be on Thursday, June 1st from 1:00-2:00 PM ET. The one-hour FREE webinar provides quarterly news and updates about AAMI’s standards program and portfolio. Registration for the upcoming webinar and recordings of past webinars in the series – including the recent March 2nd session - are available on the webpage. Check back soon for the June 1st webinar topics!
If you would like to comment on one of the draft documents listed below, contact the individual indicated by email 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 EQ56, Standard for a medical equipment management program (revision of an American National Standard). Specifies characteristics of a management program designed to support the safe and effective use of medical equipment used in an HDO. The document addresses the structure of such a program, the documentation that must be produced by the program, program staffing, and resources that should be allocated to those responsible for maintaining medical equipment. Definitions of terms and normative references are also included, as are notes and rationale that expand the provisions of the document. Contact: Michael Miskell
AAMI ST-WG02, Radiation sterilization. The working group is working on the developments of AAMI CR513/Ed.1, Guidance on radiation validation and routine maintenance for single-use systems. This document will provide guidance on simplified approaches for validation and routine maintenance of single-use systems sterilized by radiation. Contact: Mike Miskell.
AAMI ST-WG03, Moist heat sterilization. The working group is working on the development of AAMI TIR116/Ed.1, Guidance on designation of a medical product to a device product family and acceptance of a product into a product family by equivalence using moist heat sterilization. This document will provide guidance to medical device manufacturers about how to analyze the attributes of a medical device when assigning the medical device to a product family. This includes information on how to accept a new or modified medical device into a product family by equivalence. Discussion on product families for cleaning, disinfection, sterilization and human factors testing will be included. Contact: Mike Miskell.
AAMI ST-WG45, Processing of tattoo machines and accessories in healthcare settings. The working group is working on the developments of AAMI TIR117/Ed.1, Guidance for processing tattoo machines and accessories in the healthcare setting. This document will provide healthcare personnel with guidance on point-of-use treatment, transportation, testing (where applicable), cleaning, disinfection, sterilization, packaging, and storage of tattoo machines and accessories used in healthcare settings. Contact: Tommy Kim.
AAMI ST-WG61, Chemical Sterilants Hospital Practices. The working group is working on the developments of AAMI TIR118/Ed.1, Guidance on ultraviolet (UV) disinfection for medical devices in health care facilities. This document will provide guidance for healthcare facilities for the processing of medical devices using ultraviolet (UV) disinfection. The guidance is intended to provide comprehensive information and direction for healthcare personnel in the processing of reusable devices and accessories to render them safe for patient use. Contact: Tommy Kim.
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.
May 2023
AAMI ST-WG02, Radiation Sterilization Working Group (open meeting) 24 May 2023, 13:00h to 17:00h EST, web meeting. The WG will meet to discuss proposed US comments for ISO/DIS 11137‐1. Contact: Mike Miskell
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group (open meeting) 25 May 2023, 10:00h to 11:30h EST, web meeting. The WG will meet to discuss revisions to ANSI/AAMI PC76:2021. Contact: Ladan Bulookbashi
AAMI ST-WG01, Industrial Ethylene Oxide Sterilization working group (open meeting) 30 May 2023, 13:00h to 16:00h EST and 31 May 2023, 13:00h to 16:00h EST, web meeting. The WG will meet to discuss comments for ISO/DIS 11135. Contact: Tommy Kim
AAMI ID, Infusion Device Committee (open meeting) 31 May 2023, 1:30h to 3:30h EST, web meeting. The committee will meet to continue resolving comments on Working Draft-3 of AAMI/TIR 111 ED1, Infusion system performance related to occlusions and unintended boluses. Contact: Ladan Bulookbashi
June 2023
AAMI ST-WG01, Industrial Ethylene Oxide Sterilization working group (open meeting) 1 June 2023, 10:00h to 13:00h EST, web meeting. The WG will meet to discuss comments for ISO/DIS 11135. Contact: Tommy Kim
AAMI CP, Combination Products (open meeting) 6 June 2023 10:00h to 12:00h Eastern, web meeting. The committee will resolve comments for TIR 48 CDV2 Contact: Jill Zajac
AAMI SP, Sphygmomanometer Committee (open meeting) 7 June 2023, 1:00h to 3:00h EST, web meeting. The committee will meet to discuss National Adoption of ISO 81060-3:2022. Contact: Ladan Bulookbashi
AAMI TIB-WG04, Elastomeric parts, components and packaging working group (open meeting) 7 June 2023, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1st Wednesday of every month, from 10:00h to 11:00h EST, to discuss TIR 112, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group (open meeting) 15 June 2023, 10:00h to 11:30h EST, web meeting. The WG will meet virtually the 3rd Thursday of every month to discuss revisions to ANSI/AAMI PC76:2021. Contact: Ladan Bulookbashi
AAMI EQ, Medical Equipment Management Committee (open meeting) 19 June 2023, 16:00h to 17:00h EST, hybrid meeting. The Committee will meet to discuss the reaffirmation ballot of ANSI/AAMI EQ89:2015/(R)2023 and other AAMI EQ Committee/Working Group updates. Contact: Mike Miskell
AAMI EQ-WG01, HTM Program Management Working Group (open meeting) 19 and 20 June 2023, 17:00h to 20:00h and 11:00h to 15:00h EST respectively, hybrid meeting. The WG will meet to resolve comments for AAMI/CDV-2 EQ56. Contact: Mike Miskell
AAMI EQ-WG05, HTM Education Programs Working Group (open meeting) 20 June 2023, 11:00h to 15:00h EST, hybrid meeting. The WG will meet to resolve comments for AAMI/WD-1 EQ110. Contact: Mike Miskell
AAMI EQ-WG04, Alternative Equipment Maintenance Working Group (open meeting) 20 June 2023, 16:00h to 20:00h Eastern, hybrid meeting. The WG will meet to resolve comments for AAMI/WD-1 EQ103. Contact: Mike Miskell
AAMI COVID-19 response team (open meeting) 21 June 2023, 15:00h to 16:00h Eastern, web meeting. Discuss impacts of the end of the US public health emergency and other committee business. Contact: Colleen Elliott
AAMI AR, Anaesthetic and respiratory Committee and WGs (open meeting) 21 June 2023, 16:00h to 17:00h Eastern, web meeting. Discuss outcome of ISO/TC 121 plenary and affiliated meetings and other committee business. Contact: Colleen Elliott
AAMI RD, Renal Disease and Detoxification Committee (open meeting) 29 June 2023 8:00 to 16:00 Eastern, hybrid meeting. The committee will resolve comments for ISO 8637-1 and 8637-3 Contact: Jill Zajac
July 2023
AAMI TIB-WG04, Elastomeric parts, components and packaging working group (open meeting) 5 July 2023, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1st Wednesday of every month, from 10:00h to 11:00h EST, to discuss TIR 112, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda
AAMI BE and associated WGs - Biological Evaluation Standards week, (open meetings; hybrid – advanced registration REQUIRED) 18 –21 July 2023, 09:00h to 17:00h EST, Arlington, VA and web meetings. Contact: Chenai Maguwah
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group (open meeting) 20 July 2023, 10:00h to 11:30h EST, web meeting. The WG will meet virtually the 3rd Thursday of every month to discuss revisions to ANSI/AAMI PC76:2021. Contact: Ladan Bulookbashi
September 2023
AAMI Fall 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in July 2023). 11-14 September 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards
International Committee and Working Group Meetings
Information on draft international standards under ballot can be found in ANSI Standards Action.
May 2023
ISO/TC 198/WG6, Chemical Indicators (closed meetings). Virtual, 18 May and 22-23 May 2023, 08:00h to 16:00h daily EST. Contact: Mike Miskell
September 2023
IEC/TC 62, Medical equipment, software, and systems, and affiliated SC and (J)WG meetings (closed meetings). Seoul, Korea, 11-22 September 2023, 09:00h to 17:00h daily local time. Contact: Hae Choe
ISO/TC150/SC2/WG5, Renal replacement, detoxification and apheresis (closed meetings). Zoom, 18-29 September 2023, 8:00h to 12:00h EST. Contact: Jill Zajac
October 2023
ISO/TC 194, Biological and clinical evaluation of medical devices and affiliated WG meetings (closed meetings). Arlington, US, 23-27 October 2023, 09:00h to 17:00h daily local time. Contact: Chenai Maguwah
November 2023
ISO/TC 121/SC2, Airways and related equipment and ISO/TC 121/SC6, Medical gas supply systems (closed meetings). Dublin, Ireland (tent.) 13-17 November 2023, 09:00h to 17:00h daily local time. 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.