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Standards Updates

AAMI Sterilization Standards Week. (open meeting; registration required). 15 September 2025 to 18 September 2025, hybrid meeting. Select AAMI sterilization working groups will be meeting to conduct work on various AAMI, ANSI, and ISO projects. If you are interested in registering to attend, please contact sterilization@aami.org

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.

 

 

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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.

DETAILS

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.

No Calls for Comment at this time.

 

     



    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.

    The committee is working on the development of AAMI TIR130: a new Technical Information Report for Best Practices for Designing Accessible At-Home Diagnostic Test Kits  The document will provide guidance to manufacturers in the design of at-home IVD test kits – covering all aspects of the testing process, from test kit acquisition to product disposal – that are more accessible for users that have no vision or low vision or have a reduced range of manual dexterity or fine motor skills. Test kits that incorporate these improvements would also offer better usability for all users. Contact: Rachel Ann Porter
    Contact

    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.

    Contact

    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.

     

     

    Contact
    For a list of definitions for the various interest categories, click here. See section 4.5 Consensus body membership and structure.

    Publications

    The following documents have been published by AAMI. Directly and materially interested parties wishing to receive more information should contact standards@aami.org.

    ADOPTION!

    ANSI/AAMI/IEC 80601-2-58:2024

    ANSI/AAMI/IEC 80601-2-58:2024; Medical electrical equipment Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery.

    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 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

    Contact

    August 21, 2025

    AAMI TAG to TC150/SC2, Cardiovascular Implants and Extracorporeal Systems Committee.

    AAMI TAG to TC150/SC2, Cardiovascular Implants and Extracorporeal Systems Committee. (open meeting) 21 August 2025, 15:00h to 16:30h EDT, web meeting. The group will review the US positions and delegates for the upcoming ISO TC150/SC2 plenary meeting Contact: Jill Zajac 
    Contact

    August 27, 2025

    AAMI PC/CRMD, Cardiac Rhythm Management Device Committee.

    AAMI PC/CRMD, Cardiac Rhythm Management Device Committee. (open meeting) 27 August 2025, 14:00h to 16:30 EDT, web meeting. The committee will meet to discuss three ballot results and comments received on a new work item proposal. Contact: Mike Miskell  
    Contact

    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 September 2025, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1st Wednesday of every month to discuss and draft CR514, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda 

    Contact

    September 15, 2025

    AAMI ST - WG 03 - Industrial Moist Heat Sterilization.

    AAMI ST - WG 03 - Industrial Moist Heat Sterilization. (open meeting, registration required) 15 September, 13:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 15, 2025

    AAMI ST - WG 06 - Chemical Indicators.

    AAMI ST - WG 06 - Chemical Indicators. (open meeting, registration required) 15 September, 13:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 15, 2025

    AAMI ST - WG 02 - Radiation Sterilization.

    AAMI ST - WG 02 - Radiation Sterilization. (open meeting, registration required) 15 September, 13:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org
    Contact

    September 16, 2025

    AAMI ST - WG 95 - Water Quality for Reprocessing Medical Devices.

    AAMI ST - WG 95 - Water Quality for Reprocessing Medical Devices. (open meeting, registration required) 16 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org. 
    Contact

    September 16, 2025

    AAMI ST - WG 45 - Processing Tattoo Machines and Accessories in Healthcare Settings.

    AAMI ST - WG 45 - Processing Tattoo Machines and Accessories in Healthcare Settings. (open meeting, registration required) 16 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 16, 2025

    AAMI ST - WG 08 - Microbiological Methods.

    AAMI ST - WG 08 - Microbiological Methods. (open meeting, registration required) 16 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 16, 2025

    AAMI ST - WG 07 - Packaging.

    AAMI ST - WG 07 - Packaging. (open meeting, registration required) 16 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 16, 2025

    AAMI RD, Renal Disease and Detoxification Committee.

    AAMI RD, Renal Disease and Detoxification Committee (open meeting) 16 September 2025, 13:00h to 14:30h EDT, web meeting. The group will review the US positions on ISO/DIS 8637 Parts 1-3 Contact: Jill Zajac 
    Contact

    September 17, 2025

    AAMI ST - WG 11 - General Criteria for Sterilization Processes and Sterilizing Equipment.

    AAMI ST - WG 11 - General Criteria for Sterilization Processes and Sterilizing Equipment. (open meeting, registration required) 17 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 17, 2025

    AAMI ST - WG 12 - Instructions for Reusable Device Reprocessing.

    AAMI ST - WG 12 - Instructions for Reusable Device Reprocessing. (open meeting, registration required) 17 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 17, 2025

    AAMI ST - WG 61 - Chemical Sterilants Hospital Practices.

    AAMI ST - WG 61 - Chemical Sterilants Hospital Practices. (open meeting, registration required) 17 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 17, 2025

    AAMI ST - WG 86 - Quality Systems for Device Reprocessing.

    AAMI ST - WG 86 - Quality Systems for Device Reprocessing. (open meeting, registration required) 17 September, 09:00h to 17:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 18, 2025

    AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.

    AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 18 September 2025, 10:00h to 11:30h EDT, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell  
    Contact

    September 18, 2025

    Closing Plenary/US TAG to ISO/TC 198 meeting.

    Closing Plenary/US TAG to ISO/TC 198 meeting. (open meeting, registration required) 18 September, 10:00h to 12:00h EST, hybrid.  Contact: sterilization@aami.org.   
    Contact

    September 30, 2025

    AAMI CI, Cochlear implants committee.

    AAMI CI, Cochlear implants committee. (open meeting). 30 September 2025, 15:00h to 17:00h EDT, web meeting. The committee will meet for the revision of AAMI CI86. Contact: Mike Miskell  
    Contact

    October 1, 2025

    AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group.

    AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 1 October 2025, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1st Wednesday of every month to discuss and draft CR514, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda 
    Contact

    October 16, 2025

    AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.

    AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 16 October 2025, 10:00h to 11:30h EDT, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell  
    Contact

    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

    Contact

    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

    Contact

    November 20, 2025

    AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.

    AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 20 November 2025, 10:00h to 11:30h EDT, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell  
    Contact

    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
    Contact

    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

    Contact

    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

    Contact

    October 20, 2025

    ISO/TC 198, Sterilization of health care products, and affiliated WGs.

    ISO/TC 198, Sterilization of health care products, and affiliated WGs. (closed meetings) Hangzhou, China and by Zoom (20-24 October 2025), 09:00 to 17:30 daily local time. Contact: Amanda Benedict
    Contact

    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

    Contact

    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

    Contact

    November 17, 2025

    ISO/TC 121/SC2, Airway devices and related equipment and ISO/TC 121/SC6, Medical gas supply systems and affiliated WGs.

    ISO/TC 121/SC2, Airway devices and related equipment and ISO/TC 121/SC6, Medical gas supply systems and affiliated WGs. (closed meetings). Arlington, Virginia, USA, 17-21 November 2025, 09:00h to 17:00h EDT. Contact: Colleen Elliott 
    Contact

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