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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

 

 

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NOTIFICATION!

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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 ST8-202X, Hospital steam sterilizers (revision of ANSI/AAMI ST8-2013 (R2018) AAMI ST8-202X, Hospital steam sterilizers (revision of ANSI/AAMI ST8-2013 (R2018) (Revision)       This standard applies to steam sterilizers that are intended for use in hospitals and other health care facilities and that have a volume greater than 56.63 liters (L) (2 cubic feet [ft3]). Contact Gigi Golriz 
Contact
AAMI ST65:2008/(R)2018, Processing of reusable surgical textiles for use in health care facilities AAMI ST65:2008/(R)2018, Processing of reusable surgical textiles for use in health care facilities (reaffirmation of standard). This standard provides guidelines for the proper handling, processing, and preparation of reusable surgical textiles either on-site or off-site for use in health care facilities. This recommended practice specifically addresses design criteria for functional work areas; staff qualifications, education, training, dress codes, and other personnel considerations; receiving and handling of soiled surgical textiles; laundry processing considerations; transport of both soiled and clean surgical textiles; installation, care, and maintenance of laundry equipment; quality control; and regulatory considerations. Definitions of terms and a bibliography are also provided. Contact: Tommy Kim
Contact
AAMI/ISO 15882:2008/(R)2013, Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results AAMI/ISO 15882:2008/(R)2013, Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results (reaffirmation of national adoption). This document provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. AAMI/ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. Contact: Tommy Kim
Contact
AAMI HE75-202X, Human Factors Engineering – Design of Medical Devices (revision of HE75:2009) AAMI HE75-202X, Human Factors Engineering – Design of Medical Devices (revision of HE75:2009) (Revision).  This standard provides detailed human factors engineering (HFE) design guidance to those who are responsible for HFE work within medical device companies. It contains extensive design guidance, examples, checklists, and case studies. Contact Rachel Ann Porter 
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 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 ST58:2024

Chemical sterilization and high-level disinfection in health care facilities [supersedes ANSI/AAMI ST58:2013/(R)2018].

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.

December 9, 2024

AAMI CP, Combination Products Committee.

AAMI CP, Combination Products Committee. (open meeting) 09 December 2024, 14:30 to 16:00h EST, web meeting. The committee will discuss new work item proposals and upcoming work for the committee. Contact: Jill Zajac  
Contact

December 16, 2024

AAMI CI, Cochlear Implants Committee.

AAMI CI, Cochlear Implants Committee. (open meeting) 16 December 2024, 11:00h to 14:00h EST, web meeting. The WG will meet to discuss the reaffirmation ballot for AAMI CI86:2017 and propose the US position and comments for the systematic review of 14708-7:2019. Contact: Mike Miskell 
Contact

December 18, 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

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

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.

Issues

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