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AAMI BE Week, Biological Evaluation Committee and Working Groups 1-19 (hybrid meeting) May 12 – 16 from 08:00h EST to 18:00h EST. Registration coming soon. 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 EQ93:202X, Medical equipment management—Vocabulary used in medical equipment programs.
REVISION!
AAMI CI86:202X, Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting.
REVISION!
AAMI EQ89:202X, Guidance for the use of medical equipment maintenance strategies and procedures.
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 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!
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 14, 2025
AAMI RD, Renal Disease and Detoxification Committee Infusion Device Committee.
AAMI RD, Renal Disease and Detoxification Committee Infusion Device Committee.(open meeting).
14 April 2025 13:00h to 15:30h EDT, web meeting. The committee will review the ballot results for the reaffirmation of RD47 and will resolve comments for TIR123/WD2. Contact: Jill Zajac
April 15, 2025
AAMI SM-WG03, Interoperability Working Group.
AAMI SM-WG03, Interoperability Working Group. (open meeting) 1 April 2025 and 15 April 2025, 14:00h to 15:00h EST, web meeting. The WG meets the first and third Tuesday of every month to discuss the development of a new technical information report AAMI TIR115:202X, Remote Control of Medical Devices: Lung Ventilators and Intravenous (IV) Infusion Pumps. Contact: Rose Kodzwa
April 17, 2025
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 17 April 2025, 10:00h to 11:30h EDT, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell
April 24, 2025
AAMI PC/CRMD, Cardiac Rhythm Management Device Committee.
AAMI PC/CRMD, Cardiac Rhythm Management Device Committee. (open meeting) San Diego, California, USA. 24 April 2025, 07:00h to 14:00h PDT, hybrid meeting. The PC/CRMD committee will meet to discuss progress on committee work and from AAMI PC-WGs activity. Contact: Mike Miskell
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 meets the last Tuesday of every month to discuss the revision of AAMI TIR57:2016/(R)2023, Principles for medical device security—Risk Management. Its task group meets every Tuesday from 12:00h to 13:30h to develop a new technical information report AAMI TIR126:202X Security Risk Estimation for Medical Devices. 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 EDT, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell
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-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-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-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
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.
April 7, 2025
IEC/SC 62A/MT49, Health software.
IEC/SC 62A/MT49, Health software. (closed meetings) Arlington, Virginia, USA, 7-9 April 2025, 09:00h to 17:00h EDT. Contact: Colleen Elliott
April 7, 2025
ISO/TC 121/SC3/JWG10 - IEC/SC 62D/JWG5, Oximeters.
ISO/TC 121/SC3/JWG10 - IEC/SC 62D/JWG5, Oximeters. (closed meetings) Arlington, Virginia, USA, 7-11 April 2025, 09:00h to 17:00h EDT. Contact: Colleen Elliott
April 8, 2025
ISO/TC 150/SC2/WG1, Cardiac Valves.
ISO/TC 150/SC2/WG1, Cardiac Valves. (closed meetings) Newport Beach, California 8-10 April 2025, 09:00h to 17:00h PST, hybrid meeting. Contact: Jill Zajac
April 8, 2025
ISO/TC ISO/TC 150/SC2/WG1, Cardiac Valves.
ISO/TC ISO/TC 150/SC2/WG1, Cardiac Valves. (closed meetings) Irvine, California 8-10 April 2025, 09:00h to 17:00h PST, hybrid meeting. Contact: Jill Zajac
April 9, 2025
IEC/SC 62A, Common aspects of medical equipment, software, and systems, WGs 37-48 for IEC 60601-1 Ed.4.
IEC/SC 62A, Common aspects of medical equipment, software, and systems, WGs 37-48 for IEC 60601-1 Ed.4. (closed meetings). Arlington, Virginia, USA, 30 March – 4 April 2025, 09:00h to 17:00h EDT. Contact: Colleen Elliott
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