Standards Monitor Online

AAMI’s Standards Insider has been revamped. Please view our bimonthly video snippets for news and updates about AAMI’s standards program and portfolio. If there are any topics that you would like the Standards team to address, please reach out to Standards@aami.org
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STANDARDS UPDATE

The inaugural AAMI neXus: A Global Event Advancing Medical Device Standards Development, Adoption, and Application February 20-23, 2024, in Washington, DC! If you are actively involved or want to be involved in the development and adoption of medical device standards as a manufacturer, regulator, or healthcare professional, AAMI neXus will offer you unparalleled engagement opportunities and information.  At AAMI neXus you will hear directly from and interact with the industry and regulatory leaders who are driving both Development and Adoption of existing standards, as well as planning future standards works. This is your chance to get involved and help shape the future of medical device standards! 

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 TIR66/Ed.1 - Guidance for the creation of physiologic waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms  (reaffirmation of an American National Standard).  This document provides guidance to MANUFACTURERS that change existing or create new ALARM SYSTEM algorithms as to how to create evidence that demonstrates a reasonable assurance of the safety and efficacy of the algorithm. This document also provides guidance to authorities having jurisdiction for the assessment of such evidence. 
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AAMI/ISO 11737-1, Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products (reaffirmation of an American National Standard). This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package
AAMI/ISO 10993-17:202X/Ed.2, Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents (identical national adoption of ISO 10993-17:2023) This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is without appreciable harm are also specified. The toxicological risk assessment can be part of the biological evaluation of the final product, as described in ISO 10993-1. The process described in this document applies to chemical characterization information obtained in line with ISO 10993-18. When a toxicological risk assessment of either the compositional information or analytical chemistry data (e.g. extractable data or leachable data) are required to determine whether the toxicological risks related to the constituents are negligible or tolerable.
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AAMI ST58, Chemical sterilization and high-level disinfection in health care facilities (revision of an American National Standard) This standard provides guidelines for the selection and use of liquid chemical sterilants (LCSs)/high-level disinfectants (HLDs) and gaseous chemical sterilizers that have been cleared for marketing by the U.S. Food and Drug Administration (FDA) for use in hospitals and other health care facilities. These guidelines are intended to assist health care personnel in the safe and effective use of gaseous chemical sterilizing systems, LCSs/HLDs, and associated equipment.
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AAMI ST24, General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities (revision of an American National Standard). Covers minimum labeling, safety, performance, and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use in health care facilities and that have automatic controls. It also covers labeling, product composition, and container requirements for ethylene oxide sterilant sources, as well as labeling, performance, safety, and installation requirements for ethylene oxide emission control systems.
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AAMI ST77, Containment devices for reusable medical device sterilization (revision of an American National Standard). This document applies to containment devices intended for use in sterilizing reusable medical devices in health care facilities. It applies to containment devices intended for use in sterilizing reusable medical devices in health care facilities. This standard covers the design, performance, and labeling criteria for reusable rigid sterilization containers and instrument organizers intended for use in health care facilities for the purpose of containing reusable medical devices for sterilization. Definitions of terms, normative references, and informative annexes are also included, as well as the rationale and relevant test methods for the provisions of the standard. 
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AAMI/ISO TIR22456, Sterilization of health care products—Microbiological methods—Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products (reaffirmation of an American National Standard). This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. It is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.
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AAMI/ISO 11607-2, Packaging for terminally sterilized medical devices—Part 2: Validation requirements for forming, sealing and assembly processes (reaffirmation of an American National Standard). This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
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AAMI/ISO 11607-1, Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems (reaffirmation of an American National Standard). This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
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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

Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging (Addenda to ANSI/AAMI PC76:2021).

ADOPTION!

ANSI/AAMI/ISO 23500-5:202X

Preparation and quality management of fluids for haemodialysis and related therapies Part 5: Quality of dialysis fluid for haemodialysis and related therapies (identical national adoption of ISO 23500-5:2024)

ADOPTION!

ANSI/AAMI/ISO 23500-4:202X

Preparation and quality management of fluids for haemodialysis and related therapies Part 4: Concentrates for haemodialysis and related therapies (identical national adoption of ISO 23500-4:2024)

ADOPTION!

ANSI/AAMI/ISO 23500-3:202X

Preparation and quality management of fluids for haemodialysis and related therapies Part 3: Water for haemodialysis and related therapies (identical national adoption of ISO 23500-3:2024)

ADOPTION!

ANSI/AAMI/ISO 23500-2:202X

Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (identical national adoption of ISO 23500-2:2024)

ADOPTION!

ANSI/AAMI/ISO 23500-1:202X

Preparation and quality management of fluids for haemodialysis and related therapies Part 1: General requirements. (identical national adoption of ISO 23500-1:2024)

New Work

SM-WG05, Medical Device Security Working Group.

The working group is developing a new consensus report (CR) with the title Security Risk Estimation for Medical Devices. This consensus report will provide guidance for security risk estimation within the context defined by ANSI/AAMI SW96: 2023 Standard for medical device security—Security risk management for device manufacturers. Contact: Amir Aboutaleb or Matt Williams
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Publications

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

Published!

AAMI/ISO TIR10993-19:2020

Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials.

Published!

AAMI TIR16:2023

Microbiological Aspects of Ethylene Oxide Sterilization.

Reaffirmed!

AAMI/ISO TIR10993-20:2006/(R)2021

Biological Evaluation Of Medical Devices — Part 20: Principles And Methods For Immunotoxicology Testing Of Medical Devices.

Reaffirmed!

AAMI TIR17:2017/(R)2023

Compatibility of materials subject to sterilization.

Reaffirmed!

ANSI/AAMI/ISO 10993-16:2020/(R)2022

Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables.

Reaffirmed!

ANSI/AAMI/ISO 10993-14:2001/(R)2019

Biological evaluation of medical devices—Part 14: Identification and quantification of degradation products from ceramics.

Reaffirmed!

ANSI/AAMI/ISO 10993-13:2010/(R)2019

Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric devices.

Reaffirmed!

ANSI/AAMI/ISO 10993-5:2009/(R)2022

Biological evaluation of medical devices—Part 5: Tests for in vitro cytotoxicity.

Reaffirmed!

ANSI/AAMI/ISO 10993-3:2014/(R)2023

Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.

Reaffirmed!

AAMI/ISO TIR11137-4:2022/(R)2023

Sterilization of health care products—Radiation—Part 4: Guidance on process control.

Reaffirmed!

AAMI TIR12:2020/(R)2023

Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers.

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.

February 26, 2024

AAMI EQ-WG01, HTM Program Management Working Group

(open meeting) 26 February 2024, 14:00h to 16:00h EST, web meeting. The WG will resolve comments on the revision of AAMI EQ56:2013, Recommended practice for a medical equipment management program.
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March 4, 2024

AAMI EQ-WG01, HTM Program Management Working Group

(open meeting)4 March 2024, 14:00h to 16:00h EST, web meeting. The WG will resolve comments on the revision of AAMI EQ56:2013, Recommended practice for a medical equipment management program
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March 6, 2024

AAMI TIB-WG04, Elastomeric parts, components and packaging working group

(open meeting) 6 March 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)
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March 11, 2024

AAMI EQ, Medical Equipment Management Committee

(open meeting) 11 March 2024, 14:00h to 16:00h EST, web meeting. The committee will review AAMI EQ Working Groups’ recent activity and discussed plans for upcoming document revisions.
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March 21, 2024

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group

(open meeting) 21 March 2024, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021. 
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April 18, 2024

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group

(open meeting) 18 April 2024, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021.
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May 16, 2024

AAMI PC, Cardiac Rhythm Management Device Committee

(open meeting; hybrid) 16 May 2024, 9:00h to 15:00h EST, Boston, MA. 
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International Standards

International Committee and Working Group Meetings

Information on draft international standards under ballot can be found in ANSI Standards Action.

March 6, 2024

ISO/TC 210/JWG 1, Application of risk management to medical devices

(closed meetings). TENTATIVE: Arlington, Virginia, USA, 6-8 March 2024, 09:00h to 17:00h daily local time. 
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April 22, 2024

IEC/SC 62D/MT 23, Infusion pumps

(closed meeting). Arlington, Virginia, USA, April 22-26, 09:00h to 17:00h daily local time. 
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April 23, 2024

ISO/TC 150/SC 6/WG 1, Fundamental standards

(closed meeting). Arlington, Virginia, USA, April 23 and 24, 09:00h to 17:00h daily local time. 
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April 24, 2024

IEC/SC 62A, Common aspects of medical equipment, software, and systems

and affiliated WGs (closed meetings). Arlington, Virginia, USA, April 24 – May 3, 09:00h to 17:00h daily local time. 
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April 25, 2024

ISO/TC 150/SC 6/JWG 1, Cardiac pacemakers and implantable defibrillators

(closed meeting). Arlington, Virginia, USA, April 25 and 26, 09:00h to 17:00h daily local time. 
Contact

May 13, 2024

ISO/TC 121, Anaesthetic and respiratory equipment

and affiliated SCs and (J)WGs (closed meetings). Luebeck, Germany, May 13 – 17, 09:00h to 17:00h daily local time. 
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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. 
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Issues