Welcome to the Standards Monitor Online (SMO)
Subscribe NowStandards Updates
AAMI 2025 Spring Sterilization Standards Week. Registration for the upcoming AAMI 2025 Spring Sterilization Standards Week, 17-20 March 2025 (hybrid meeting) is open through March 10. For more information and to register, please visit the AAMI Training & Events webpage.
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
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 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.
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
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.
March 17, 2025
AAMI March 2025 Spring Sterilization Standards Week.
AAMI March 2025 Spring Sterilization Standards Week. (open meeting, registration required) 17 March 2025 to 20 March 2025, hybrid meeting. The AAMI Sterilization Standards Committee and select AAMI Sterilization Working Groups will be convening to conduct business meetings to complete work on relevant sterilization projects. For more information and to register, please visitAAMI Training & Events webpage. Contact: sterilization@aami.org
March 20, 2025
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
March 25, 2025
AAMI SMWG05, Device Security Working Group.
AAMI SMWG05, Device Security Working Group. (open meeting) 25 March 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 at 12:00h to 13:00h to develop a new technical information report AAMI TIR126:202X Security Risk Estimation for Medical Devices. Contact: Rose Kodzwa
April 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 April 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
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. More details to follow. Contact: Jill Zajac
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
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 08:00h EST to 18:00h EST. 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.
March 17, 2025
ISO/TC 150/SC2/WG-5, Renal replacement, detoxification and apheresis.
ISO/TC 150/SC2/WG-5, Renal replacement, detoxification and apheresis. (closed meetings). Web meeting March. 17 – 18 March 2025, 08:00h to 11:00h EST Contact: Jill Zajac
March 24, 2025
ISO/TC 210/JWG 3 – IEC/SC 62A/JWG4, Usability.
ISO/TC 210/JWG 3 – IEC/SC 62A/JWG4, Usability. (closed meetings). Arlington, Virginia, USA, 24-28 March 2025, 09:00h to 17:00h EDT. Contact: Colleen Elliott
March 25, 2025
ISO/TC 150/SC 6/JWG 1. Joint ISO/TC 150/SC 6 - IEC/SC 62D WG: Cardiac pacemakers and implantable defibrillators.
ISO/TC 150/SC 6/JWG 1. Joint ISO/TC 150/SC 6 - IEC/SC 62D WG: Cardiac pacemakers and implantable defibrillators. (closed meetings). Arlington, Virginia, USA, 25-26 March 2025, 09:00h to 17:00h EDT. Contact: Mike Miskell
March 30, 2025
IEC/SC 62A, Common aspects of medical equipment, software, and systems, WGs 37-48.
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
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
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
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