Standards Monitor Online
STANDARDS UPDATE
Thank you!
The inaugural AAMI neXus: A Global Event Advancing Medical Device Standards Development, Adoption, and Application, February 20-22, 2024, in Washington, DC was a huge success! We want to express our sincere appreciation to all the attendees and speakers as well as our co-sponsor, the U.S. FDA – your insight and engagement throughout the conference helped make AAMI neXus 2024 a truly memorable event. We look forward to an even bigger and better AAMI neXus 2025!
Join us
AAMI eXchange 2024
June 14-17, 2024 | Phoenix, AZ
The Phoenix Convention Center, North Building
Join us for four days where the entire field of healthcare technology management comes together to learn, connect with peers, and showcase the
latest innovations, upgrades, and advances in health technology—which is where you come in!
NOTIFICATION!
NEW! We have completed transitioning our standards groups to the NEW AAMI StMP (Standards Management Platform) platform! 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.
AMENDMENT!
AAMI PC76:2021/A1:202X
ADOPTION!
ANSI/AAMI/ISO 23500-5:202X
ADOPTION!
ANSI/AAMI/ISO 23500-4:202X
ADOPTION!
ANSI/AAMI/ISO 23500-3:202X
ADOPTION!
ANSI/AAMI/ISO 23500-2:202X
ADOPTION!
ANSI/AAMI/ISO 23500-1:202X
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.
SM-WG05, Medical Device Security Working Group.
Publications
Published!
ANSI/AAMI/ISO 13004:2022
Published!
AAMI/ISO TIR10993-19:2020
Reaffirmed!
AAMI/ISO TIR10993-20:2006/(R)2021
Reaffirmed!
ANSI/AAMI/ISO 10993-16:2020/(R)2022
Reaffirmed!
ANSI/AAMI/ISO 10993-14:2001/(R)2019
Reaffirmed!
ANSI/AAMI/ISO 10993-13:2010/(R)2019
Reaffirmed!
ANSI/AAMI/ISO 10993-5:2009/(R)2022
Reaffirmed!
ANSI/AAMI/ISO 10993-3:2014/(R)2023
Reaffirmed!
AAMI/ISO TIR11137-4:2022/(R)2023
Reaffirmed!
AAMI TIR12:2020/(R)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 send a brief note to the AAMI Standards Department (standards@aami.org) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
March 21, 2024
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group
March 25, 2024
Spring 2024 Sterilization Standards Week
(open meeting) 25 – 28 March 2024, 9:00h to 17:00h EST, in-person and virtual meeting. Arlington, VA. The AAMI Sterilization Standards Committee and select AAMI Sterilization Working Groups will be convening to conduct business meetings to progress various sterilization projects. Advance registration is required to attend.
April 3, 2024
AAMI TIB-WG04, Elastomeric parts, components and packaging working group
April 18, 2024
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group
May 1, 2024
AAMI TIB-WG04, Elastomeric parts, components and packaging working group
May 16, 2024
AAMI PC, Cardiac Rhythm Management Device Committee
June 5, 2024
AAMI TIB-WG04, Elastomeric parts, components and packaging working group
June 12, 2024
AAMI EQ-WG01, HTM Program Management working group
June 13, 2024
AAMI EQ-WG05, HTM Educational Programs working group
June 13, 2024
AAMI EQ-WG04, Alternative Equipment Maintenance working group
June 14, 2024
AAMI EQ, Medical Equipment Management Committee
International Standards
International Committee and Working Group Meetings
Information on draft international standards under ballot can be found in ANSI Standards Action.
April 22, 2024
IEC/SC 62D/MT 23, Infusion pumps
April 23, 2024
ISO/TC 150/SC 6/WG 1, Fundamental standards
April 24, 2024
IEC/SC 62A, Common aspects of medical equipment, software, and systems
April 25, 2024
ISO/TC 150/SC 6/JWG 1, Cardiac pacemakers and implantable defibrillators
May 13, 2024
ISO/TC 121, Anaesthetic and respiratory equipment
October 21, 2024
IEC/TC 62, Medical equipment, software, and systems, and affiliated SC and (J)WG meetings
(closed
meetings). London, UK, 14-18 and Edinburgh, Scotland, 21-25 October 2024, 09:00h to 17:00h daily local time.