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Standards Updates

AAMI BE Week, Biological Evaluation Committee and Working Groups 1-19 (hybrid meeting) May 12 – 16 from 08:30h EST to 17:00h EST. Registeration is now close. Contact: Rose Kodzwa

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.

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.

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!

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.

Published!

REAFFIRMED! ANSI/AAMI/ISO 14117:2019/(R)2025

ANSI/AAMI/ISO 14117:2019/(R)2025, Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.

Published!

REAFFIRMED! ANSI/AAMI EQ93:2019/(R)2025

ANSI/AAMI EQ93:2019/(R)2025, Medical equipment management—Vocabulary used in medical equipment programs.

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.

May 12, 2025

Biological Evaluation Week Spring 2025

AAMI BE Week, Biological Evaluation Committee and Working Groups 1-19. (hybrid meeting) May 12 – 16 from 08:30h EST to 17:00h EST at the AAMI office in Arlington VA. Registration is now open. Contact: Rose Kodzwa

Contact

May 12, 2025

AAMI BE Week, Biological Evaluation Committee and Working Groups 1-19.

AAMI BE Week, Biological Evaluation Committee and Working Groups 1-19. (hybrid meeting) May 12 – 16 from 08:30h EST to 17:00h EST at the AAMI office in Arlington VA. Registration is now open. Contact: Rose Kodzwa

Contact

May 15, 2025

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

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 15 May 2025, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell

Contact

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-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-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-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 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 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

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.

May 12, 2025

ISO/TC 121, Anaesthetic and respiratory equipment, and affiliated SC and (J)WG meetings.

ISO/TC 121, Anaesthetic and respiratory equipment, and affiliated SC and (J)WG meetings. (closed meetings). Paris France. 12 – 16 May, 09:00h to 17:00h daily local time. Contact: Colleen Elliott

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

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

Issues

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