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AAMI BE Week, Biological Evaluation Committee and Working Groups 1-19 (hybrid meeting) May 12 – 16 from 08:30h EST to 17:00h EST. Register online. 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.
NOTIFICATION!
NEW! Looking for training on AAMI Standards Management Platform (StMP)? Information is available
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.
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 SM-WG10, Cloud Computing.
AAMI ST-WG17, Cleaning and Disinfection (CD) Working Group.
AAMI EQ-WG04, Alternate Equipment Management (AEM) Working Group.
AAMI EQ-WG04, Alternate Equipment Management Working Group. The working group is developing a new AAMI Technical Information Report (TIR129); Guidance on implementation and use of AAMI EQ103. This TIR provides explanatory material for healthcare delivery organizations interested in establishing, implementing and sustaining an industry accepted AEM program compliant with AAMI EQ103:2024/Ed. 1, Alternate Equipment Management (AEM) Program in Healthcare Delivery Organizations (HDOs). It includes checks and balances that help ensure safety and quality are not compromised in the process. Additional information included in this guidance document offers examples of potential methods for building an AEM program. This document includes discussions on metrics, data analysis, and risks associated with data quality. The TIR will not endorse any specific AEM strategies. Contact: Mike Miskell
AAMI EQ-WG03, Technology acquisition (TA) working group.
AAMI EQ-WG01, HTM Program Management Working Group.
Publications
Published!
AAMI TIR109:2025
Published!
REAFFIRMED! AAMI TIR43:2021/(R)2025
Published!
REAFFIRMED! ANSI/AAMI/ISO 14117:2019/(R)2025
Published!
REAFFIRMED! ANSI/AAMI EQ93:2019/(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.
April 29, 2025
AAMI SM-WG05, Device Security Working Group.
AAMI SM-WG05, Device Security Working Group. (open meeting) 29 April 2025, 13:00h to 14:00h EST, web meeting. The WG will meet virtually the last Tuesday of every month, from 13:00h to 14:00h EST, to discuss and draft TIR57, Principles for medical device security-Risk management. Contact: Rose Kodzwa
May 5, 2025
AAMI EQ-WG05, HTM Education Programs Working Group.
AAMI EQ-WG05, HTM Education Programs Working Group. (open meeting) 5 May 2025, 10:00h to 13:00h EDT, web meeting. The WG will meet to discuss potential updates to ANSI/AAMI EQ110:2024. Contact: Mike Miskell
May 7, 2025
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group.
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 7 May2025, 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
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
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
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
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
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 AAMI/WD-1 TIR128. Contact: Mike Miskell
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 resolve comments for AAMI/WD-1 EQ93. Contact: Mike Miskell
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 resolve comments for AAMI/WD-1 EQ94. Contact: Mike Miskell
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 to resolve comments for AAMI/WD-1 TIR129. Contact: Mike Miskell
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
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
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
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
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