Standards Monitor Online
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.
This standard applies to dry heat (heated air) sterilizers that are intended for use in dental and medical offices, laboratories, ambulatory-care clinics, hospitals, and other health care facilities. Contact: Mike Miskell
(proposed identical national adoption of ISO 11607-1:2019/Amd 1:2023) This amendment narrows the scope to AAMI/ISO 11607-1:2019 and revises some terms and definitions, general requirements, design and development for packaging systems, and annexes relating to risk management. Contact: Mike Miskell
AAMI/ISO 13408-1:202X, Aseptic processing of health care products — Part 1: General requirements. (proposed identical national adoption of ISO 13408-1:2023) This document specifies the general requirements for, and offers guidance on, processes, programs and procedures for development, validation and routine control of aseptic processing of health care products. This document includes requirements and guidance relative to the overall topic of aseptic processing. Contact: Mike Miskell
(proposed identical national adoption of ISO 11137-2:2013/Amd 1: 2022) This amendment adds new normative references, adds a subclause to clause 6 Methods of dose establishment, updates clause 9 title, updates subclause 9.1 title and text. Contact: Mike Miskell
New Work
AAMI AI, Artificial Intelligence Committee
The committee will work on the development of AAMI CR515/Ed.1, Taxonomy of Medical Device Machine Learning Cybersecurity Threats and Protection Techniques. This new consensus report will identify the unique cybersecurity threats and vulnerabilities along with potential controls for Machine Learning (ML) based medical devices. This would include a discussion about different types of attacks on ML systems, for e.g., privacy attacks, poisoning attacks, and availability attacks, as well as a discussion about the vulnerabilities that enable such attacks. An analysis of the vulnerabilities that can manifest throughout the data lifecycle will also be presented. Potential controls to mitigate these threats and vulnerabilities will also be explored. Contact: Rachel Porter
AAMI AI, Artificial Intelligence Committee
Publications
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 10993-13:2010/(R)2019
Reaffirmed!
ANSI/AAMI/ISO 10993-5:2009/(R)2022
Reaffirmed!
ANSI/AAMI/ISO 10993-5:2009/(R)2022
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.
December 5, 2023
AAMI SP, Sphygmomanometer Committee
December 7, 2023
AAMI EQ-WG04, Alternative equipment maintenance working group
December 7, 2023
AAMI EQ-WG05, HTM Education programs working group
December 13, 2023
AAMI TIB-WG04, Elastomeric parts, components and packaging working group (open meeting)
International Standards
International Committee and Working Group Meetings
Information on draft international standards under ballot can be found in ANSI Standards Action.
December 5, 2023
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care and JWG12
December 5, 2023
ISO/TC 210, Quality management and corresponding general aspects for products with a health purpose including medical devices
December 11, 2023
ISO/TC 210, Quality management and corresponding general aspects for products with a health purpose including medical devices and affiliated (J)WG meetings (closed meetings)
ISO/TC 210, Quality management and corresponding general aspects for products with a health purpose including medical devices and affiliated (J)WG meetings (closed meetings). Paris, France, 5-8 and 11-15 December 2023, 09:00h to 17:00h daily local time. Contact: Amanda Benedict
February 5, 2024
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care and JWG12 (closed meetings)
Sydney, Australia, 5 - 9 February 2024. Contact: Colleen Elliott
AAMI ST40, Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities. (reaffirmation of an American National Standard) This recommended practice provides guidelines for decontamination and dry heat sterilization procedures used in dentists’ and physicians’ offices, laboratories, ambulatory care clinics, and other health care facilities. These guidelines are intended to promote the assurance of sterility by identifying the special considerations that apply to this method of sterilization and by providing recommendations on the proper use of table-top dry heat sterilization processing equipment. This recommended practice also covers facility design considerations, personnel considerations, work practices, and other variables that affect sterility assurance. Contact: Mike Miskell