Standards Monitor Online
Standards Updates
Nominations are open for the 2025 AAMI and AAMI Foundation Awards, including the AAMI Standards Awards. The deadline for submitting nominations is January 16, 2025.
For details on the selection criteria and required documents for nominations, please refer to the following links:
- AAMI Standards Developer Award: Presented to up to five individuals who have made significant contributions to the development or revision of an AAMI standard or international standard (ISO or IEC).
- AAMI Technical Committee Award: Recognizes exceptional efforts of an AAMI technical committee. Up to two AAMI technical committees are honored annually for their outstanding contributions to standards development.
- AAMI Sterilization Science Award: Presented to one recipient for significant and sustained contributions to advancing healthcare sterilization, sterility assurance, and contamination control.
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 TIR12:202X
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-WG96, Compatibility of Materials Subject to Sterilization Working Group.
AAMI ST-WG61, Chemical Sterilants Hospital Practices Working Group.
AAMI ST-WG11, General Criteria for Sterilization Processes and Sterilizing Equipment Working Group.
RD, Renal Disease and Detoxification Committee.
AAMI PC-WG01, Transvenous Cardiac Leads Working Group.
The working group is developing the following two new AAMI Standards (Contact: Mike Miskell):
AAMI PC85; Requirements for Fatigue Performance of Cardiac Rhythm Management Leads. This standard outlines requirements for characterizing the fatigue performance of cardiac leads based on benchtop fatigue testing and bending stiffness measurements, focusing on conductor integrity. It excludes polymer and elastomeric components, bonds, biodegradation, and corrosion. Methods are provided for measuring lead bending stiffness and fatigue strength in different regions, for preconditioning leads, and for accepting fatigue performance through comparison with proven designs or using a Bayesian model to predict survival rates based on lead stiffness.
AAMI PC125; Implantable leads—Perforation propensity—Requirements and test methods. This standard establishes a method to assess the perforation propensity of permanently implantable cardiac pacing and defibrillation leads for transvenous use in the right atrium or ventricle, excluding preformed “J”-shaped and left bundle branch area pacing leads. It focuses on the acute phase post-implantation, prior to fibrotic encapsulation, and does not address all aspects of perforation propensity, such as implant technique or patient-specific factors. The methods and criteria are based on conventional leads and may not apply to novel designs or unique clinical applications.
Publications
Published!
ANSI/AAMI ST58:2024
Published!
ANSI/AAMI/ISO 11607-2:2019/A1:2023
Published!
ANSI/AAMI/ISO 11607-1:2019/A1:2023
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.
January 8, 2025
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group.
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 8 January 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
January 14, 2025
AAMI EQ-WG02, Servicing Vocabulary Working Group.
AAMI EQ-WG02, Servicing Vocabulary Working Group. (open meeting) 14 January 2025, 13:30h to 15:30h EST, web meeting. The WG will meet to review progress for development of the first working draft for the revision of AAMI EQ93. Contact: Mike Miskell
January 16, 2025
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group. (open meeting) 16 January 2025, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell
February 17, 2025
AAMI EQ-WG02, Servicing Vocabulary Working Group.
AAMI EQ-WG02, Servicing Vocabulary Working Group. (TENTATIVE) (open meeting) 17 February 2025, 11:00h to 12:30h EST, web meeting. The WG will meet to review progress for development of the first working draft for the revision of AAMI EQ93. 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.
January 20, 2025
ISO/TC 121/SC3, Respiratory devices and related equipment for patient care.
February 4, 2025
ISO/TC 121/SC2, Airway devices and related equipment.
ISO/TC 121/SC2, Airway devices and related equipment. (closed meeting). London, UK, 4-5 February, 09:00h to 17:00h daily local time. 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
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