Standards Monitor Online
Reaccreditation of AAMI under Revised Operating Procedures
The Association for the Advancement of Medical Instrumentation (AAMI) is pleased to announce that it was reaccredited as an ANSI Accredited Standards Developing Organization (SDO) on July 24, 2024. This is a result of the recent audit performed on AAMI’s standards operations. All ANSI accredited SDOs are required to undergo an audit and reaccreditation every five years. AAMI’s next audit will be in 2029.
Accreditation by ANSI signifies that AAMI’s voluntary consensus development standards procedures meet ANSI’s requirements for openness and due process. Accreditation by ANSI is a prerequisite for a SDO to submit documents for approval as American National Standards (ANS).
As a result of this audit, AAMI revised its Standards Program Policies and Procedures to address the identified non-compliances with ANSI Essential Requirements. The updated procedures were approved by the AAMI Standards Board on June 21, 2024, and by ANSI on June 24, 2024.
The 2024 AAMI Standards Program Policies and Procedures can be accessed publicly on AAMI’s website here.
AAMI Biological Evaluation Week meetings (open meetings; hybrid) 3 – 7 February 2025, 08:00h to 18:00h EST, Arlington, VA and web meetings. Contact: Rose Kodzwa
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.
AAMI/ISO 11135:2014 (R202x), Sterilization of health care products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process for medical devices (reaffirmation of a national adoption). This standard specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices. Contact: Tommy Kim
AAMI/ISO 11140-3: 2007/(R)2015 (R202x), Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (reaffirmation of a national adoption) This standard specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Contact: Tommy Kim
AAMI RD47-2020 (R202x), Reprocessing of hemodialyzers (reaffirmation)
This standard is addressed to the physician responsible for reprocessing hemodialyzers. It covers personnel and patient considerations, records, equipment, physical plant and environmental safety, reprocessing material, patient identification and hemodialyzer labeling, reprocessing and storage procedures, disposition of rejected dialyzers, preparation for subsequent use, patient monitoring, and quality assurance and quality control. This document does not endorse either single use or reuse of dialyzers. Contact: Jill Zajac
AAMI/ISO 11140-1:2014 (R202x), Sterilization of health care products—Chemical indicators—Part 1: General requirements (reaffirmation of a national adoption). This standard specifies performance requirements for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances. Contact: Tommy Kim
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 TIR57:202X
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/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.
October 21, 2024
AAMI HE, Human Factors Engineering Committee.
AAMI HE, Human Factors Engineering Committee. (open meeting) 21-22 October 2024, 9:00h to 4:30h EST, Hybrid meeting. AAMI/HE is meeting to discuss incoming new work items on Successful Human Factors (SHF 2.0) and Accessible At Home in Vitro Diagnostic (IVD) Tests, and reviewing current work under development. as well as updates on program of work under development. Contact: Rachel Ann Porter
October 23, 2024
AAMI EQ-WG02, Servicing vocabulary working group.
AAMI EQ-WG02, Servicing vocabulary working group. (open meeting) 23 October 2024, 14:00h to 16:00h EST, web meeting. The WG is meeting to discuss a ballot voting and comments report for the reaffirmation of AAMI EQ93: 2019, Medical equipment management—Vocabulary used in medical equipment programs. Contact: Mike Miskell
October 28, 2024
AAMI RD, Renal Disease and Detoxification Committee.
AAMI RD, Renal Disease and Detoxification Committee. (open meeting) San Diego, CA. 28 October 2024 09:00h to 16:30h PST, hybrid. The committee will discuss comments on the working draft of new work item TIR 123, User Considerations - Design of Activated Carbon Systems for Hemodialysis with Non-Continuous Flow – Empty-Bed Contact Time (EBCT) Calculation and review reaffirmation ballot results Contact: Jill Zajac
October 30, 2024
AAMI PC, Cardiac Rhythm Management Devices Committee
November 6, 2024
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group.
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 6 November 2024, 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 CR514, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda
November 21, 2024
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group (open meeting) 21 November 2024, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell
December 4, 2024
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group.
AAMI TIB-WG04, Elastomeric parts, components and packaging Working Group. (open meeting) 4 December 2024, 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
December 19, 2024
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.
December 30, 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
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.
October 21, 2024
IEC/TC 62, Medical equipment, software, and systems, and affiliated SC and (J)WG meetings
Contact: Colleen Elliott or Ladan Bulookbashi
November 18, 2024
(reaffirmation of a national adoption) This standard specifies a comprehensive test methodology for the evaluation of the electromagnetic (EM) compatibility of active implantable cardiovascular devices. The devices addressed by this standard include those that provide one or more therapies for bradycardia, tachycardia, and cardiac resynchronization. This document details test methods appropriate for the interference frequencies at issue. It specifies performance limits or requires disclosure of performance in the presence of EM emitters, where indicated. Contact: Mike Miskell