AAMI Standards Monitor Online 7 March 2022
Standards Monitor Online
About Standards Monitor Online
Standards Monitor Online (SMO) is a free subscription service that is delivered to your email every three weeks. This AAMI resource keeps you up to date with standards-related activities:
AAMI Standards Insider
The AAMI Standards Insider webinar series was last held on Thursday, February 24th from 1:00-2:00 PM ET. This one-hour FREE webinar provided news and updates about AAMI’s standards program and portfolio. The next webinar will be held on Thursday, May 19th 2022, from 1:00-2:00 PM ET. Register here.
AAMI Call for Comments
If you would like to comment on one of the draft documents listed below, contact the individual indicated by e-mail to receive a PDF copy of the draft. These copies are free.
Published documents proposed for reaffirmation can be purchased from the AAMI Store.
Comments due April 21, 2022
AAMI CDV-1 ST108, Water for the processing of medical devices (proposed new American National Standard). Covers the selection and maintenance of effective water quality suitable for processing 26 medical devices. It provides guidelines for selecting the water quality necessary for the processing 27 of categories of medical devices and addresses water treatment equipment, water distribution and 28 storage, quality control procedures for monitoring water quality, strategies for bacterial control, 29 and environmental and personnel considerations. Contact: Jody Allen
AAMI/ISO CDV-1 11138-8, Sterilization of health care products – Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (identical national adoption of ISO 11138-8:2021). Specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. Contact: Jody Allen
AAMI/ISO CDV-1 15223-1, Medical devices– Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (identical national adoption of ISO 15223-1:2021, to supersede ANSI/AAMI/ISO 15223-1:2016). Specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards. Contact: Amanda Benedict
AAMI EQ, Medical Equipment Management Committee. The committee is working on the development of AAMI EQ110/Ed.1, Guidance for health care technology management education programs. This standard seeks to provide a recommended framework for new or established education programs in health care technology management (HTM). Contact: Ovidiu Munteanu
AAMI SM-WG10, Cloud Computing. The AAMI Standards Board has approved the formation of a new working group under AAMI SM, Software and Information Technology, and authorized the group to begin work on a Technical Information Report based on the approved AAMI CR510:2021, Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices. This new WG is seeking members from the General interest, Industry, Regulatory and User categories to join.
Contact: Ovidiu Munteanu
AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use Committee. The committee has recently approved development of a new AAMI Technical Information Report (TIR) on Guidance for Closed System Transfer Device Testing with Hazardous Drugs. This TIR seeks to provide guidelines for physical and chemical compatibility of the drug with the Closed System Transfer Device (CSTD), which may include but not limited to holdup volume, coring/fragmentation of the vial rubber stopper, microbial ingress, stability/shelf-life, and usability. The committee is in the process of appointing cochairs and is seeking user, regulatory and general interest members to participate in the development of AAMI TIR112. Contact: Sam Alameda
The committees listed below are seeking new members in the indicated stakeholder interest category to participate in the development of their documents. Definitions of the various stakeholder groups are:
User
An individual or organizational representative, who purchases, utilizes or receives the materials, products, systems, or services covered in the scope of technical documents developed by AAMI in the delivery of healthcare; individuals in this interest category include clinicians, employees or representatives of Healthcare Delivery Organizations, clinical consultants, patients, etc
Industry
An individual or organizational representative involved in the commercial production, promotion, sale, use or distribution of materials, products, systems, or services covered in the scope of technical documents developed by AAMI; this interest category includes manufacturers, those involved in supply chains, employees of test labs or commercial labs, industry consultants, etc.
Regulatory
An individual or organizational representative involved in the regulation of the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI; this interest category includes those representing federal, state, local, foreign, or other government entities
General interest
An individual or organizational representative with a general material interest in the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI and who does not fit into any of the preceding categories; this interest category can include noncommercial academicians, noncommercial researchers, patient or consumer advocates, representatives of accrediting organizations, representatives of other organizations, etc.
Please contact the staff person indicated for more information on how to join.
- AAMI CN, Small bore connectors. The committee is seeking user, regulatory, and general interest members to participate in the development of AAMI/ISO 80369-1/Ed.3, Small-bore connectors for liquids and gases in healthcare applications – Part 1: General requirements; AAMI/ISO 80369-2/Ed.1, Small-bore connectors for liquids and gases in healthcare applications – Part 2: Connectors for respiratory applications; and AAMI/ISO 80369-20/Ed.2, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods. Contact: Colleen Elliott
- AAMI EQ, Medical equipment management. The committee is seeking industry, regulatory and general interest members to participate in the development of AAMI EQ110/Ed.1, Guidance for health care technology management education programs. Contact: Ovidiu Munteanu
- AAMI ST-WG06, Chemical indicators. The working group is seeking user, regulatory and general interest members to participate in the reaffirmations of the national adoptions of several parts of the ISO 11140 series. Contact: Jody Allen
- AAMI ST-WG13, Washer-disinfectors. The working group is seeking user, regulatory and general interest members to participate in the reaffirmations of AAMI ST15883-2 and AAMI ST15883-3.
Contact: Jody Allen - AAMI ST-WG43, Hospital steam sterilizers. The working group is seeking user, regulatory and general interest members to participate in the reaffirmation of AAMI ST55, Table-top steam sterilizers and the revision of AAMI ST8, Hospital steam sterilizers. Contact: Jody Allen
- AAMI ST-WG84, Endoscope reprocessing. The working group is seeking regulatory and general interest members to participate in the development of AAMI TIR99/Ed.1, Dilators, transesophageal and ultrasound probes processing in health care facilities. Contact: Jody Allen
- AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. The committee and its affiliated working groups are seeking user, industry, and general interest/regulator members to participate in developing the U.S. position towards documents under development in ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use, and other projects. Contact: Sam Alameda
- AAMI CV, Cardiac valves. The committee is seeking user, industry, and general interest/regulator members to participate in the U.S. adoption of ISO 5840-1:202x, Cardiovascular implants — Cardiac valve prostheses — Part 1: General requirements; ISO 5840-2:202x, Cardiovascular implants — Cardiac valve prostheses — Part 2: Surgically implanted heart valve substitutes; ISO 5840-3:202x, Cardiovascular implants — Cardiac valve prostheses — Part 3: Heart valve substitutes implanted by transcatheter techniques; and the revision of ISO 5910:2018, Cardiovascular implants and extracorporeal systems — Cardiac valve repair devices. Contact: Ladan Bulookbashi
- AAMI VP, Vascular Prostheses. The committee is seeking user, industry, and general interest/regulator members to participate in the U.S. adoption of ISO 25539-2:2020, Cardiovascular implants — Endovascular devices — Part 2: Vascular stents; the revision of ISO 25539-3, Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters. Contact: Ladan Bulookbashi
- AAMI BG, Blood/Gas Exchange Device. The committee is seeking user, industry, and general interest/regulator members to participate in the development of the following Cardiovascular implants and artificial organs documents: ISO 18193, Cannulae for extracorporeal circulation; Amendment 1 to ISO 18242:2016 Centrifugal blood pumps for pulsatile pumps; and revision of ISO 7199, Blood-gas exchangers. Contact: Ladan Bulookbashi
- AAMI VP-WG 01, Vascular Device-Drug Combination Products. The committee is seeking user, industry, and general interest/regulator members to participate in the revision of ISO 12417-1:2015, Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 1: General requirement. Contact: Ladan Bulookbashi
- AAMI RD, Renal Disease and Detoxification. The committee is seeking industry, user, and general interest/regulator members to participate in the revision of the ISO 23500:2019 , Preparation and quality management of fluids for haemodialysis and related therapies series standards: Part 1: General requirements; Part 2: Water treatment equipment for haemodialysis applications and related therapies; Part 3, Water for haemodialysis and related therapies; Part 4: Concentrates for haemodialysis and related therapies; Part 5, Quality of dialysis fluids for haemodialysis and related therapies; and the revision of the ISO 8637, Extracorporeal systems for blood purification series standards: Part 1, Haemodialysers, haemodiafilters, haemofilters, and haemoconcentrators, Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters; and Part 3, Plasmafilters. Contact: Ladan Bulookbashi
- AAMI HIT-WG02, Health IT Quality Systems Working Group. The working group is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI HIT1000-2/Ed., Health IT software and systems — Part 2: Application of quality systems principles and practices. Contact: Ovidiu Munteanu
- AAMI AI, Artificial Intelligence. The committee is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI TIR 34971, Guidance on the Application of ISO 14971 to Artificial and Machine Learning. Contact: Hae Choe
- AAMI SM-WG01 - Software Working Group. The group is seeking user, general interest, and regulatory members to participate in the development of TIR45: Guidance on the use of AGILE practices in the development of medical device software. Contact: Ovidiu Munteanu
- AAMI SM-WG03 - Interoperability Working Group. The group is seeking general interest, regulatory, and users. The committee is developing a new American national standard, AAMI Safe Remote Control of Medical Devices. Contact: Ovidiu Munteanu
- AAMI SM-WG05 - Medical Device Security Working Group. The group is seeking general interest, regulatory, and users. The committee is developing a new American national standard, AAMI SW96, Standard for medical device security — Security risk management for device manufacturers.
Contact: Ovidiu Munteanu - AAMI SM-WG10 - Cloud Computing Working Group. The group is seeking industry, user, general interest, and regulatory members to participate in the development of a TIR based on the approved AAMI CR510:2021, Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices. Contact: Ovidiu Munteanu
- AAMI EV-WG05, Hospital Beds Working Group. The group is seeking industry, user, general interest, and regulatory members to participate in the development of IEC 80601-2-52 ED1: Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds,
and IEC 80601-2-89 ED1: Medical electrical equipment - Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children.
Contact: Ladan Bulookbashi - AAMI SU, Sustainability. The committee is seeking user, industry, and general interest/regulatory members to participate in the reaffirmation of AAMI TIR65, Sustainability of medical devices – Elements of a responsible product life cycle. Contact: Chenai Maguwah
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.
March 2022
AAMI Spring 2022 Sterilization Standards Week (open meetings – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28-31 March 2022, 08:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG84, Endoscope reprocessing (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG96, Compatibility of materials subject to sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG08, Microbiological methods (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 28 March 2022, 13:00h to 17:00h ET and 29 March 2022, 08:00h to 12:00h ET, Arlington, VA and web meetings.
Contact: sterilization@aami.org
AAMI ST-WG40, Steam sterilization hospital practices (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 29 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG95, Water quality for reprocessing medical devices (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 29 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG02, Radiation sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 29 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG43, Hospital steam sterilizers (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 08:00h to 12:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG01, Industrial EO sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG61, Chemical sterilants hospital practices (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 09:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI Protective Barriers Committee (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 30 March 2022, 13:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG62, Hospital EO sterilizers (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 31 March 2022, 08:00h to 12:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
AAMI ST-WG03, Industrial moist heat sterilization (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 31 March 2022, 10:00h to 12:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org
US TAG to ISO/TC 198 (open meeting – advance registration REQUIRED; general registration to open week of March 7th through the AAMI Store). 31 March 2022, 13:00h to 15:00h ET, Arlington, VA and web meeting. Contact: sterilization@aami.org
AAMI ST-WG44, Steam sterilization dental practices (open meeting). 1 April 2022, 09:00h to 13:00h ET, web meeting. Contact: Amanda Benedict
International Standards
Information on draft international standards under ballot can be found in ANSI Standards Action.
International Committee and Working Group MeetingsCall or email the indicated staff person at AAMI for more information about upcoming international standards meetings.
March 2022
ISO/TC 150/SC 2/ WG 1, Cardiac valves (closed meeting) 7 and 8 March 2022, 15:30h to 19:00h CET, Zoom meeting. Contact: Ladan Bulookbashi
ISO/TC 150/SC 2/ WG 6, Vascular device-drug combination products (closed meeting) 22 and 24 March 2022, 9:00h to 11:00h ET, Zoom meeting. Contact: Ladan Bulookbashi
ISO/TC 210/WG 7, Good engineering maintenance management (closed meeting), 7 March 2022, 20:00h to 22:30h MYT, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 13, Washer-disinfectors (closed meeting), 10 March 2022, 08:00h to 11:00h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 29 March 2022, 13:00h to 16:00h GMT, Zoom meeting. Contact: Amanda Benedict
July 2022
ISO/TC 121, Anaesthetic and respiratory equipment (closed meeting), 11 to 15 July 2022, St. Johns, Canada. Contact: Colleen ElliottMiscellaneous
AAMI, in collaboration with the British Standards Institution, is launching an effort to develop standards for artificial intelligence (AI) and machine learning (ML) in medical technologies. In May of this year, AAMI published a whitepaper discussing the need for new standards and regulator initiatives to promote the safety, effectiveness, and availability of AI and ML in healthcare. (https://www.aami.org/detail-pages/press-release/aami-bsi-position-paper-sets-machine-learning-agenda)
There were seven recommendations made in the whitepaper. One of the most urgent was for guidance on applying ISO 14971, Medical Devices—Application of Risk Management to Medical Devices, when evaluating medical technology utilizing AI and, in particular, ML. AAMI and BSI have established a partnership to jointly develop a document which provides this guidance, as well as other needed AI standards identified in the whitepaper.
As a result of this initial work, AAMI is creating a new consensus body, tentatively call the AAMI Artificial Intelligence Committee (AAMI AI) to develop this work. Interested parties, including representatives of clinical practices, academia, regulatory authorities, and industry should contact standards@aami.org for more information about the project or participation on the committee.
Issues