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

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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!

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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 EQ103, Alternate equipment management (AEM) in healthcare facilities (proposed new American National Standard). This document provides a framework for the development and ongoing management of an AEM program. It assists healthcare delivery organizations (HDOs) seeking to meet the related Conditions of Participation set by the Centers for Medicare and Medicaid Services (CMS). By incorporating a quantitative, scientific, and risk-based methodology, along with input from clinical staff, this document establishes minimum requirements for AEM programs. For devices included in an AEM program, this document provides requirements for procedures that assure acceptable levels of safety and performance are maintained.
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AAMI EQ56, Standard for a medical equipment management program (proposed new American National Standard). This document specifies minimum requirements for a management program designed to minimize risks associated with medical equipment that is used during the care of patients in a healthcare delivery organization. This document addresses the structure of the program, documentation requirements, staffing, resources, relationship/client management, service continuity and availability, change management, and quality management associated with the management of medical equipment.
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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). Contact: Mike Miskell Email: mmiskell@aami.org

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) Contact: Jill Zajac Email: jzajac@aami.org

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) Contact: Jill Zajac Email: jzajac@aami.org

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) Contact: Jill Zajac Email: jzajac@aami.org

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) Contact: Jill Zajac Email: jzajac@aami.org

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). Contact: Jill Zajac Email: jzajac@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.

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
Contact

Publications

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

Published!

ANSI/AAMI/ISO 11737-1:2018/A1:2021

Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products—AMENDMENT 1. 

Published!

ANSI/AAMI/ISO 11140-6:2024

Sterilization Of Health Care Products—Chemical Indicators—Part 6: Type 2 Indicators And Process Challenge Devices For Use In Performance Testing Of Small Steam Sterilizers. 

Published!

AAMI TIR106:2024

Microbiological Methods—Understanding And Use Of Product Bioburden Data.

Published!

ANSI/AAMI/ISO 13004:2022

Sterilization of Health Care Products—Radiation—Substantiation of Selected Sterilization Dose: Method VDmaxSD.

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.

April 22, 2024

AAMI CV, Cardiac Valve Prostheses Committee

 (open meeting), 22 April 2024, 13:00h to 16:00h EST, virtual meeting. 
Contact

May 1, 2024

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

(open meeting) May 1, 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

May 16, 2024

AAMI PC, Cardiac Rhythm Management Device Committee

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

June 5, 2024

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

(open meeting) June 5, 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

June 12, 2024

AAMI EQ-WG01, HTM Program Management working group

(open meeting). Phoenix, Arizona, USA. 12-13 June, 17:00h to 20:00h and 11:00 to 20:00h EDT, respectively, hybrid meeting. The WG will meet to resolve comments for AAMI/CDV-3 EQ56.
Contact

June 13, 2024

AAMI EQ-WG05, HTM Educational Programs working group

(open meeting). Phoenix, Arizona, USA. 13 June, 11:00 to 15:00h EDT, hybrid meeting. The WG will meet to resolve comments for AAMI/CDV-1 EQ110.
Contact

June 13, 2024

AAMI EQ-WG04, Alternative Equipment Maintenance working group

(open meeting). Phoenix, Arizona, USA. 13 June, 16:00 to 20:00h EDT, hybrid meeting. The WG will meet to resolve comments for AAMI/CDV-1 EQ103.
Contact

June 14, 2024

AAMI EQ, Medical Equipment Management Committee

(open meeting). Phoenix, Arizona, USA. 14 June, 13:00h to 15:00h 20:00h EDT hybrid meeting. The Committee will meet to review working group progress and steering for future AAMI EQ and EQ WGs projects.
Contact

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

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

April 22, 2024

ISO/TC 198/WG 4, Biological indicators

Virtual, April 22, 09:00h to 12:00h EDT.
Contact

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. 
Contact

April 24, 2024

IEC/TC 62/WG4, Terminology

(closed meeting). Arlington, Virginia, USA, April 24 – 26, 09:00h to 17:00h daily local time. 
Contact

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

April 29, 2024

IEC/SC 62A Common aspects of medical equipment, software, and systems WGs 37 – 48

to work on the 4th edition of IEC 60601-1 (closed meetings). Arlington, Virginia, USA, April 29 – May 3, 09:00h to 17:00h daily local time
Contact

May 6, 2024

IEC/SC 62A/MT 49

Arlington, Virginia, USA, May 6, 13:30 - 17:00h, May 7 – 8 ,09:00 – 17:00h, May 9, 09:00 – 13:00h 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. 
Contact

June 24, 2024

ISO/TC 198, Sterilization of health care products

and affiliated WGs (closed meetings). Galway, Ireland, June 24-28, 09:00h to 17:30h daily local time.
Contact

September 9, 2024

ISO/TC 150, Implants for surgery and affiliated SC and WG meetings

(closed meetings). Berlin, DE, September 9-13 2024, 09:00h to 17:00h daily local time
Contact

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

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