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
Download
NOTIFICATION!
NEW! Looking for training on AAMI Standards Management Platform (StMP)? Information is available
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
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
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
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
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
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
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
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
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.
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.
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.
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).
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
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
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.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.
Issues
17 December 16 2022
16 November 29 2022
12 September 2 2022
12 August 2022REV
11 August 12 2022
SMO 10 July 22 2022
SMO 10 July 22 2022
July 1 2022
9 July 1 2022
8 June 10 2022
7 May 27 2022 (1)-5-31-22
7 May 27 2022
6 May 4 2022
April 15 2022
15 April 15 2022
March 28 2022
March 7 2022
2 February 11 2022 (1)
2 February 11 2022
1 January 24 2022 REV1
24 January 21 2022
1 January 21 2022
Jan112022REV1
Jan112022
11January2022
10 January 2022
16 December 4 2020 SMO
15 November 13 2020 SMO
14 October 23 2020 SMO
October 2020 Sterilization Standards Web Meetings Details
13 October 2 2020 SMO
12 September 11 2020 SMO
11 August 21 2020 SMO
10 July 31 2020 SMO
09 July 10 2020 SMO
07 May 22 2020 SMO
06 May 1 2020 SMO
05 April 10 2020 SMO
04_March_20_2020_SMO
03_February_28_2020_SMO
Standards Monitor, February 7, 2020