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Standards Updates

Check out our New Work section for our three new works.

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

 

 

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NOTIFICATION!

NEW! Looking for training on AAMI Standards Management Platform (StMP)? Information is available

DETAILS

AAMI Call for Comments

None currently. 

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.

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.

AMENDMENT!

AAMI EQ110:2024/AMD1

AMENDMENT! AAMI EQ110:2024/AMD1 Healthcare technology management (HTM) educational programs Amendment 1. Contact: mmiskell@aami.org - Mike Miskell

ADOPTION!

AAMI/ISO 5840-3:2021/AMD1

AAMI/ISO 5840-3:2021/AMD1 Cardiovascular implants Cardiac valve prostheses Part 3; Heart valve substitutes implanted by transcatheter techniques Amendment 1 (identical national adoption of ISO 5840-3:2021/Amd 1:2025.) Contact: JZajac@aami.org - Jill Zajac

ADOPTION!

AAMI/ISO 5840-2:2021/AMD1

AAMI/ISO 5840-2:2021/AMD1 Cardiovascular implants Cardiac valve prostheses Part 2: Surgically implanted heart valve substitutes Amendment 1 (identical national adoption of ISO 5840-2:2021/Amd 1:2025.) Contact: JZajac@aami.org - Jill Zajac

ADOPTION!

AAMI/ISO 5840-1:2021/AMD1

AAMI/ISO 5840-1:2021/AMD1 Cardiovascular implants Cardiac valve prostheses Part 1: General requirements Amendment 1 (identical national adoption of ISO 5840-1:2021/Amd 1:2025.) Contact:: JZajac@aami.org - Jill Zajac

REVISION!

AAMI CI86:202X, Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting.

Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting. Contact: mmiskell@aami.org - Mike Miskell

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 Improving Accessibility and Usability of At-Home In Vitro Diagnostic_IVD_Test  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

Check the next edition of the SMO for any new publications.

Published!

REAFFIRMED! AAMI TIR77:2018/(R)2025

REAFFIRMED! AAMI TIR77:2018/(R)2025; Sorbent-based regenerative hemodialysis systems.

Published!

REAFFIRMED! AAMI TIR72:2017/(R)2025

REAFFIRMED! AAMI TIR72:2017/(R)2025; Dialysis fluid chemical composition.

Published!

REAFFIRMED! AAMI TIR62:2014/(R)2025

REAFFIRMED! AAMI TIR62:2014/(R)2025; Generating reports for the purpose of submitting defibrillation waveform data for evaluation.

Published!

REAFFIRMED! AAMI TIR61:2014/(R)2025

REAFFIRMED! AAMI TIR61:2014/(R)2025; Generating reports for human factors design validation results for external cardiac defibrillators.

Published!

REAFFIRMED! AAMI CI86: 2017/(R)2025

AAMI CI86: 2017/(R)2025; Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting.

Published!

AAMI TIR109:2025

AAMI TIR109:2025; External transport of reusable medical devices for processing

Published!

REAFFIRMED! AAMI TIR58:2021/(R)2025

AAMI TIR58:2021/(R)2025 Water testing methodologies.

Published!

REAFFIRMED! AAMI TIR43:2021/(R)2025

AAMI TIR43:2021/(R)2025 Ultrapure dialysis fluid for hemodialysis and related therapies.

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.

June 3, 2025

AAMI CI, Cochlear implants committee.

AAMI CI, Cochlear implants committee. (open meeting). 3 June 2025, 15:00h to 17:00h EDT, web meeting. The committee will meet for the revision of AAMI CI86. Contact: Mike Miskell
Contact

June 4, 2025

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

AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 4 June 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

Contact

June 11, 2025

AAMI ST-WG08, Microbiological Methods Working Group.

AAMI ST-WG08, Microbiological Methods Working Group. (open meetings). 11, 18 and 25 June 2025 from 11:00h EST to 14:00h EST. The purpose of these meetings is to resolve comments for AAMI TIR52, Environmental monitoring for terminally sterilized healthcare products. Contact: Gigi Golriz

Contact

June 18, 2025

AAMI EQ-WG01, HTM Program Management Working Group.

AAMI EQ-WG01, HTM Program Management Working Group. (open meeting). New Orleans, Louisiana, USA. 18 June 2025, 08:00h to 17:00h CDT, hybrid meeting. The WG will meet to resolve comments for AAMI/WD-1 EQ89 and continue preparation of AAMI/WD-1 TIR128. Contact: Mike Miskell

Contact

June 19, 2025

AAMI EQ-WG03, Technology Acquisition Working Group.

AAMI EQ-WG03, Technology Acquisition Working Group. (open meeting). New Orleans, Louisiana, USA. 18-19 June 2025, 14:00h to 17:00h and 08:00h to 14:30h CDT, respectively, hybrid meeting. The WG will meet to continue preparation of AAMI/WD-1 EQ94. Contact: Mike Miskell

Contact

June 19, 2025

AAMI EQ-WG02, Servicing Vocabulary Working Group.

AAMI EQ-WG02, Servicing Vocabulary Working Group. (open meeting). New Orleans, Louisiana, USA. 19 June 2025, 08:00h to 14:00h CDT, hybrid meeting. The WG will meet to continue preparation of AAMI/WD-1 EQ93. Contact: Mike Miskell

Contact

June 19, 2025

AAMI EQ-WG04, Alternate Equipment Management Working Group.

AAMI EQ-WG04, Alternate Equipment Management Working Group. (open meeting). New Orleans, Louisiana, USA. 18-19 June 2025, 14:00h to 17:00h and 09:00h to 14:30h CDT, respectively, hybrid meeting. The WG will meet tocontinue preparation of AAMI/WD-1 TIR129. Contact: Mike Miskell

Contact

June 19, 2025

AAMI EQ, Medical Equipment Management Committee.

AAMI EQ, Medical Equipment Management Committee. (open meeting). New Orleans, Louisiana, USA. 19 June 2025, 15:00h to 17:30h CDT, hybrid meeting. The Committee will meet to review working group progress and steering for future AAMI EQ and EQ WGs projects. Contact: Mike Miskell

Contact

July 2, 2025

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

AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 2 July 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

Contact

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

Contact

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

Contact

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

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

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

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

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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