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:

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STANDARDS UPDATE

NEW! We have completed transitioning our standards groups to the NEW AAMI Committee Central platform! Information is available here.

Publications

NEWSWORTHY!! IMDRF publishes new technical document for Artificial Intelligence Medical Devices (AIMD) | More information is available here.

NEWSWORTHY!! FDA Updates Recognized Consensus Standards Database with List 58 | More information is available here.

NEWSWORTHY!! AAMI Response to GI Societies Statement on ANSI/AAMI ST91 | More information is available here.

NEWSWORTHY!! Europe recognizes ISO 14971:2019, Application of risk management to medical devices | More information is available here.

REAFFIRMED! AAMI TIR67:2018/(R)2022, Promoting safe practices pertaining to the use of sterilant and high-level disinfectant chemicals in healthcare facilities is available here.

REAFFIRMED! AAMI TIR68:2018/(R)2022, Low and intermediate level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental s surfaces is available here.

PUBLISHED! ANSI/AAMI 2700-2-1:2022, Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging is available here.

PUBLISHED! ANSI/AAMI HIT1000-1:2022, Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements is available here.

PUBLISHED! AAMI TIR100:2021, End-to-end microbiological quality and sterility assurance is available here.

PUBLISHED! AAMI TIR104:2022, Guidance on transferring health care products between radiation sterilization source is available here.

AAMI Standards Insider

The AAMI Standards Insider webinar series was last held on Thursday, May 19^th 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, August 18^th from 1:00-2:00 PM ET. Registration for upcoming webinars and recordings of past webinars are available here.

National Standards

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.

All drafts documents with AAMI public review period closed on May 30^th.

New Work

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: Jody Allen

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. TIB-WG04 is seeking cochairs, user, regulatory and general interest members to participate in the development of AAMI TIR112. We are currently scheduled for a meeting on 20 July, 10:30 – 11:30 am (CST), if interested in attending email. Contact: Sam Alameda

Consensus Body Members Needed

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 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: Jody Allen
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-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: Jill Zajac
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: Jill Zajac
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: Jill Zajac
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: Jill Zajac
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: Jill Zajac
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 TIR34971, 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

Upcoming Meetings

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.

June 2022

AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen

July 2022

AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen

AAMI TIB, Transfusion, Infusion and Injection, and Blood Processing Equipment for Medical and Pharmaceutical Use. AAMI TIB WG04 will meet on July 20th, 2022, 10:30-11:30 am (CST), to discuss AAMI TIR112, Guidance for closed system transfer device (CSTD) testing with hazardous drugs, next steps in its development. Contact: Sam Alameda

August 2022

AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen

AAMI SP, Sphygmomanometer Committee (open meeting). 8 August 2022, 11:00h to 12:30h EDT, web meeting. Contact: Ladan Bulookbashi

September 2022

AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen

AAMI Fall 2022 Sterilization Standards Week (open meetings – advanced registration REQUIRED; registration to open in early July). 12-15 September 2022, 08:00h to 17:00h ET, Arlington, VA and web meetings. Contact: sterilization@aami.org

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.

June 2022

ISO/TC 198/WG 8, Microbiological methods (closed meeting), 28-29 June 2022, 06:00h – 09:00h MST, web meetings. Contact: Amanda Benedict

ISO/TC 198/WG 9, Aseptic processing (closed meeting), 30 June 2022, 11:00h – 15:00h CEST, web meetings. Contact: Amanda Benedict

July 2022

ISO/TC 121, Anaesthetic and respiratory equipment and affiliated groups (closed meetings), 11-15 July 2022, St. John’s, Newfoundland, Canada. Contact: Colleen Elliott

Miscellaneous

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.