Welcome to the Standards Monitor Online (SMO)
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Our “New Work” section has three new documents.
AAMI Standards Insider
AAMI’s Standards Insider has been revamped. Please view our quarterly video snippets for news and updates about AAMI’s standards program and portfolio here. If there are any topics that you would like the Standards team to address, please reach out to Standards@aami.org.
NOTIFICATION!
NEW! Looking for training on AAMI Standards Management Platform (StMP)? Information is available
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
The following projects have been initiated by AAMI. Directly and materially interested parties wishing to receive more information or to submit comments are to contact the individual indicated by email.
ADOPTION!
AAMI/ISO 5840-3:2021/AMD1
ADOPTION!
AAMI/ISO 5840-2:2021/AMD1
ADOPTION!
AAMI/ISO 5840-1:2021/AMD1
REVISION!
AAMI CI86:202X, Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting.
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
Published!
AAMI TIR109:2025
Published!
AAMI TIR43:2021/(R)2025
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.
July 17, 2025
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 17 July 2025, 10:00h to 11:30h EDT, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell
July 22, 2025
AAMI CI, Cochlear Implants Committee.
AAMI CI, Cochlear Implants Committee. (open meeting) 22 July 2025, 15:00h to 17:00h EDT, web meeting. The WG will meet to review progress made on action items for the revision of AAMI CI86. Contact: Mike Miskell
July 24, 2025
AAMI PC/CRMD, Cardiac Rhythm Management Device Committee.
AAMI PC/CRMD, Cardiac Rhythm Management Device Committee. (open meeting) 24 July 2025, 10:00h to 13:00 EDT, web meeting. The committee will meet to discuss three ballot results and comments received on a new work item proposal. Contact: Mike Miskell
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
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 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 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