Welcome to the Standards Monitor Online (SMO)
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AAMI Standards Insider
Visit the AAMI’s Standards Insider here to watch our quarterly video updates featuring news, highlights, and developments from AAMI’s standards program and portfolio.
Have a topic you'd like us to cover in a future video? We welcome your suggestions—reach out to us at Standards@aami.org.
NOTIFICATION!
Looking for training on AAMI Standards Management Platform (StMP)? Information is available here.
We’re excited to announce that a "Guide to Voting and Commenting on AAMI Draft Documents" is now available in the “Help” section of StMP.
This guide offers clear, step-by-step instructions to support your engagement in the standards development process—whether you are casting a vote or providing comments on draft documents. Committee members are encouraged to review this guidance document, and contact us at standards@aami.org with any questions or comments you may have.
AAMI Call for Comments
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.
Comments Due July 28, 2025
- AAMI ST65:2008/(R)20xx, Processing of reusable surgical textiles for use in health care facilities (reaffirmation of American National Standard). This document provides guidelines for the proper handling, processing, and preparation of reusable surgical textiles either on-site or off-site for use in health care facilities. Contact: Tommy Kim
- AAMI/ISO 11737-3, Sterilization of health care products – Microbiological methods – Part 3: Bacterial endotoxin testing (identical national adoption of ISO 11737-3:2023 Ed.1). This document specifies general criteria to be applied in the determination of bacterial endotoxins test (BET) methods, using amebocyte lysate reagents. Contact Gigi Golriz.
Project Initiation Notice
Check the next edition of SMO for any new project initiations.
New Work
Initiation of the following New Work Items have been approved and added to AAMI’s standards work program. Directly and materially interested parties wishing to receive more information or to submit comments are to contact the individual indicated by email.
AAMI HE, Human Factors Engineering.
AAMI STW-G08, Microbiological Methods Working Group.
The working group is working on the development of AAMI CR517: a new Consensus Report for Comparison of ANSI AAMI ST72_2019 and ISO 11737-3_2023. This document provides a summary of the differences between the two listed documents, which would help to facilitate the evaluation and implementation of ISO 11737-3:2023. Contact: Gigi Golriz.
AAMI ST-WG02, Radiation sterilization working group.
The working group is working on the development of AAMI TIR131: a new Technical Information Report for Guidance for Use of Parametric Release in the Radiation Sterilization of Healthcare Products. This document would establish guidelines for implementing and maintaining parametric release in healthcare product sterilization for all radiation modalities. Contact: Gigi Golriz.
Publications
ADOPTION!
ANSI/AAMI/IEC 80601-2-58:2024
Upcoming National Events
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 reach out to the committee staff liaison listed below or contact the AAMI Standards Department at (standards@aami.org) indicating the name and date of the meeting.
August 6, 2025
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group.
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 6 August 2025, 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 and draft CR514, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda
August 21, 2025
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 21 August 2025, 10:00h to 11:30h EDT, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell
September 3, 2025
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group.
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 3 Sept 2025, 10:00h to 12:00h EST, web meeting. (Tentative user panel discussion follow-up meeting), to discuss CR514, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda
November 3, 2025
AAMI RD, Renal Disease and Detoxification Committee.
AAMI RD, Renal Disease and Detoxification Committee. (open meeting) Houston, TX. 3 November 2025, 9:00h to 17:00h CST, hybrid meeting. Contact: Jill Zajac
November 6, 2025
AAMI CP, Combination Products Committee.
AAMI CP, Combination Products Committee. (open meeting) AAMI offices Arlington, VA 6 November 2025, 9:00h to 17:00h EST, hybrid meeting. Contact: Jill Zajac
December 10, 2025
AAMI AR, Anaesthetic and Respiratory equipment committee and AR/WGs
AAMI AR, Anaesthetic and Respiratory equipment committee and AR/WGs (open meeting), virtual. 10 December 2025, 15:00h to 16:00h. Contact: Colleen Elliott
International Standards
Information on draft international standards under ballot can be found in ANSI Standards Action.
International Committee and Working Group Meetings
Call or email the indicated staff person at AAMI for more information about upcoming international standards meetings.
September 18, 2025
ISO/TC 198/WG 12, Information for reprocessing of resterilizable devices.
ISO/TC 198/WG 12, Information for reprocessing of resterilizable devices. (closed meeting) Arlington, Virginia, USA and by Zoom (18-19 September 2025), 09:00 to 17:00 daily local time. Contact: Amanda Benedict
September 22, 2025
ISO/TC ISO/TC 150/SC2,Cardiovascular implants and extracorporeal systems, and affiliated WG meeting.
ISO/TC ISO/TC 150/SC2,Cardiovascular implants and extracorporeal systems, and affiliated WG meeting. (closed meetings). , Caparica Portugal 22 – 26 September, approx. 09:00h to 17:00h daily WET time. Contact: Jill Zajac
October 20, 2025
ISO/TC 198, Sterilization of health care products, and affiliated WGs.
October 27, 2025
ISO/TC 210 WG-01 - Application of quality systems to medical devices.
ISO/TC 210 WG-01 - Application of quality systems to medical devices. (closed meeting). Arlington, Virginia, USA, 27-31 October 2025, 8:00h to 17:00h EDT. Contact: Rachel Ann Porter
November 3, 2025
IEC/TC 62, Medical equipment, software, and systems, and affiliated SC and (J)WG meetings.
IEC/TC 62, Medical equipment, software, and systems, and affiliated SC and (J)WG meetings. (closed meetings). Milan, Italy, (Tentatively 3 – 14 November), 09:00h to 17:00h daily local time. Contact: Colleen Elliott or Ladan Bulookbashi
November 17, 2025