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Standards Updates
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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.
December 9, 2024
AAMI CP, Combination Products Committee.
December 16, 2024
AAMI CI, Cochlear Implants Committee.
December 18, 2024
AAMI EQ-WG01, HTM Program Management Working Group.
AAMI EQ-WG01, HTM Program Management Working Group. (open meeting) Dates and times TBD, web meeting. The WG will meet for project development and timeline planning. Contact: Mike Miskell
December 19, 2024
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
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.