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 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!

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 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 and revision of ANSI/AAMI/ISO 23500-5-2019). This document specifies minimum chemical and microbiological quality requirements for dialysis fluids used in haemodialysis and related therapies. This document applies to - dialysis fluids used for haemodialysis and haemodiafiltration, - substitution fluid produced online for haemodiafiltration and haemofiltration based on dialysis fluid. Contact: Jill Zajac
Contact
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 and revision of ANSI/AAMI/ISO 23500-4-2019). This document specifies chemical and microbiological requirements for concentrates used for haemodialysis and related therapies and applies to the manufacturer of such concentrates. This document is applicable to - concentrates in both liquid and powder forms. - additives, also called spikes, which are chemicals that can be added to the concentrate to supplement or increase the concentration of one or more of the existing ions in the concentrate and thus in the final dialysis fluid. - equipment used to mix acid and bicarbonate powders into concentrate at the user's facility. Contact: Jill7 Zajac
Contact
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 and revision of ANSI/AAMI/ISO 23500-3-2019). This document specifies the minimum chemical and microbiological quality requirements, for water used for preparation of dialysis fluids, concentrates, and for the reprocessing of haemodialysers, together with the necessary steps to ensure conformity with the requirements. It provides guidance for the ongoing monitoring of the purity of such water in terms of chemical and microbiological quality. This document is applicable to - water used in the preparation of dialysis fluids for haemodialysis, haemodiafitraytion and haemofiltration and the reprocessing of haemodialysers - water used in the preparation of concentrates. Contact: Jill Zajac
Contact
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 and revision of ANSI/AAMI/ISO 23500-2-2019). This document specifies requirements and recommendations for individual water treatment devices and water treatment systems assembled from one or more of such devices. This document is directed at the individual or company that specifies the complete water treatment system and, the supplier who assembles and installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this document are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended to be used to supply water for haemodialysis and related therapies. Contact: Jill Zajac
Contact
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 and revision of ANSI/AAMI/ISO 23500-1-2019). This document specifies the general requirements for the preparation of fluids for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration, for dialysis practitioners. It provides guidance on the user's responsibility for fluids used in haemodialysis and related therapies once the equipment used in its preparation has been delivered and installed. Contact: Jill Zajac
Contact
BSR/AAMI/IEC 80601-2-78-2020/A1, Amendment 1 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (identical national adoption of IEC 80601-2-78:2019/AMD1:2024). Applies to the general requirements for basic safety and essential performance of medical robots that physically interact with a patient with an impairment to support or perform rehabilitation, assessment, compensation or alleviation related to the patient’s movement functions, as intended by the manufacturer. Contact: Ladan Bulookbashi 
Contact
AAMI/IEC 80601-2-77-2020/A1, Amendment 1 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (identical national adoption of IEC 80601-2-77:2019/AMD1:2023). Applies to the basic safety and essential performance of Robotically Assisted Surgical Equipment (RASE) and Robotically Assisted Surgical Systems (RASS), referred to as ME Equipment and ME Systems together with their interaction conditions and interface conditions. Contact: Ladan Bulookbashi 
Contact
AAMI/IEC 80601-2-58-202X, Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (identical national adoption of IEC 80601-2-58:2024 and revision of ANSI/AAMI/IEC 80601-2-58-2014. Applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment (ME equipment). Contact: Ladan Bulookbashi
Contact
AAMI EQ93, Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery (reaffirmation of an American National Standard). This standard provides consensus definitions for key terms used in medical equipment management around the maintenance, repair and servicing of medical devices, so that all stakeholders involved in the regulation, management and use of medical devices have common understanding when they are used.
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.

AMENDMENT!

AAMI ST91:2021

AAMI ST91:2021, Flexible And Semi-Rigid Endoscope Processing In Health Care Facilities. Contact Tommy Kim tkim@aami.org

ADOPTION!

AAMI/ISO 8637-202X

AAMI/ISO 8637-202X, Extracorporeal systems for blood purification Part 3: Plasmafilters (identical national adoption of ISO 8637-3:2024 Ed 2.) Contact: Jill Zajac at jzajac@aami.org

ADOPTION!

AAMI/ISO 8637-2:202x,

Extracorporeal systems for blood purification Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (identical national adoption of ISO 8637-2:2024 Ed 2.) Contact: Jill Zajac at jzajac@aami.org

ADOPTION!

AAMI/ISO 8637-1:202x

Extracorporeal systems for blood purification Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (identical national adoption of ISO 8637-1:2024 Ed 2. ) Contact: Jill Zajac at 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: Rose Kodzwa
Contact

Publications

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

Published!

AAMI TIR99:2024

Processing of Dilators, Transesophageal and Ultrasound Probes In Health Care Facilities.

Published!

AAMI TIR48:2024

Quality management systems (QMS) recommendations on application of the U.S. FDA’s CGMP final rule on combination products.

Published!

ANSI/AAMI ST24:2024

General-Purpose Ethylene Oxide Sterilizers With Automated Process Control And Ethylene Oxide Sterilant Sources Intended For Use In Health Care Facilities.

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.

July 18, 2024

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

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

July 22, 2024

AAMI CV, Cardiac Valves Committee

(open meeting) 22 July 2024, 10:30h to 12:00h EST, web meeting. The WG will review 5840-1:2021/DAmd1, 5840-2:2021/DAmd1 and 5840-3:2021/DAmd1 comments and discuss new work items.
Contact

August 7, 2024

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

7 August 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

August 15, 2024

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

(open meeting) 15 August 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

September 4, 2024

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

open meeting) 4 September 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

September 19, 2024

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

(open meeting) 19 September 2024, 10:00h to 11:30h EST, web meeting. The WG meets monthly to discuss revisions to ANSI/AAMI PC76:2021.
Contact

International Standards

International Committee and Working Group Meetings

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

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