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

 

Download the Latest Issue

NOTIFICATION!

NEW! Looking for training on AAMI Standards Management Platform (StMP)? Information is available

DETAILS

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 14117:2019, Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices AAMI/ISO 14117:2019, Active implantable medical devices—Electromagnetic compatibility—EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices 

 (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

Contact
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

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

Contact
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

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

Contact
AAMI/ISO 11140-5:2007/(R)2015, Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal tests AAMI/ISO 11140-5:2007/(R)2015, Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal tests (reaffirmation of a national adoption). This standard specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles. Additionally, this part of ISO 11140 includes test methods and equipment used to meet these performance requirements. Contact: Tommy Kim
Contact
AAMI/ISO 11140-4:2007/(R)2015, Sterilization of health care products - Chemical indicators - Part 4- Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration AAMI/ISO 11140-4:2007/(R)2015, Sterilization of health care products - Chemical indicators - Part 4- Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (reaffirmation of a national adoption). This standard specifies the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads). Contact: Tommy Kim
Contact
AAMI RD47-2020 (R202x), Reprocessing of hemodialyzers

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

Contact
AAMI/ISO 11140-1:2014 (R202x), Sterilization of health care products—Chemical indicators—Part 1: General requirements

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

Contact

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

AAMI TIR57:202X, Principles for medical device security – Risk management. Contact: Rose Kodzwa

REVISION!

AAMI TIR12:202X

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers. Contact: Gigi Golriz. Email: ggolriz@aami.org

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-WG96, Compatibility of Materials Subject to Sterilization working group. The working group will be developing a new AAMI Technical Information Report (AAMI TIR122); Considerations for Material Retention of Sterilant Residuals in Ethylene Oxide Sterilization. This TIR provides: fundamental background on factors that may affect sterilant residual retention by device materials; data showing relative retention of sterilant residuals retained by various materials after processing in ethylene oxide; guidelines on how to address the impact of medical device material selection or material changes on the potential for sterilant residual retention; and provides data on the impact of cycle attributes and aeration conditions (e.g. temperature, vacuum changes, etc.) on retained EO residuals. It will clarify differences in the effects of EO retention by materials between occupational or environmental EO exposure and exposure to patients through sterilized devices. Contact: Gigi Golriz.
Contact

AAMI ST-WG61, Chemical Sterilants Hospital Practices Working Group.

The working group will be developing a new AAMI Technical Information Report (AAMI TIR121); Guidance on cleaning and disinfection of patient care equipment in patient care areas to render safe for handling and next patient use. This TIR provides guidance to health care personnel who perform cleaning and low-level and intermediate level disinfection of patient care equipment outside of the sterile processing area. Excludes devices and materiel addressed by ANSI/AAMI ST79 and ANSI/AAMI ST91 and environmental surfaces. Contact: Tommy Kim
Contact

AAMI ST-WG11, General Criteria for Sterilization Processes and Sterilizing Equipment Working Group.

The working group will be developing a series of AAMI Technical Information Reports (AAMI TIR124-X); Guidance on transferring health care products between gas or vapor sterilization modalities. These series provide guidance on alignment of various gas and vapor sterilization modalities with ISO 14937 and other relevant standards for industrial sterilization (not health care; not decontamination) where there is a gap in guidance relative to the validation, routine control, biological indicators and sterilant residuals for the modality. Examples of such modalities can be found in AAMI TIR17. Each part of this series will focus on a specific modality. Contact: Gigi Golriz
Contact

RD, Renal Disease and Detoxification Committee.

The committee is specifically looking for additional members to represent user, general, and regulatory interest categories to participate in the development of a new Technical Information Report on User Considerations - Design of Activated Carbon Systems with Non-Continuous Flow – Empty-Bed Contact Time (EBCT) Calculation, and identical adoption of the ISO 23500 parts 1-5:2024, Preparation and quality management of fluids for haemodialysis and related therapies  standards and identical adoption of ISO 8637-1 through -3, Extracorporeal systems for blood purification series standards. Contact: Jill Zajac 
Contact

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.  

Contact
For a list of definitions for the various interest categories, click here. See section 4.5 Consensus body membership and structure.

Publications

Check the next edition of the SMO for any new publications.

Published!

ANSI/AAMI/ISO 11607-2:2019/A1:2023

Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes Amendment 1: Application of risk management

Published!

ANSI/AAMI/ISO 11607-1:2019/A1:2023

Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems Amendment 1: Application of risk management

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 17, 2024

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group (open meeting) 17 October 2024, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell  

Contact

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

Contact

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

Contact

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

Contact

October 30, 2024

AAMI PC, Cardiac Rhythm Management Devices Committee

AAMI PC, Cardiac Rhythm Management Devices Committee (open meeting) 30 October 2024 (Times TBD), Arlington, VA / hybrid web meeting. The Committee will meet for activity updates and to review comments received to the first working draft of AAMI TIR107:202X, Ed.1, Cardiovascular implantable electronic devices - Battery longevity management and reporting. Contact: Mike Miskell 
Contact

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

Contact

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

Contact

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

Contact

December 19, 2024

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group.

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group (open meeting) 19 December 2024, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. Contact: Mike Miskell 
Contact

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

Contact

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

(closed meetings). London, UK, 14-18 and Edinburgh, Scotland, 21-25 October 2024, 09:00h to 17:00h daily local time. 

Contact:  Colleen Elliott or Ladan Bulookbashi

Contact

November 18, 2024

ISO/TC 121/SC2, Airway devices and related equipment and ISO/TC 121/SC6, Medical gas supply systems

(closed meetings). Vienna, Austria, November 18-22. 
Contact

Issues

Contact Us