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 BE-WG18, Attributes of medical devices relevant to biological risk assessment Working Group. AAMI is seeking industry, user, general interest, and regulatory members for the newly formed working group to provide input on ISO TC/194/WG 18 activities. Contact: Chenai Maguwah
AAMI BG, Blood/Gas Exchange Device Committee. The committee is seeking user, industry, and general interest/regulator members to participate in reaffirmation of 11658, Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems and revision of ISO 7199, Cardiovascular implants and artificial organs — Blood-gas exchangers Blood-gas exchangers and to provide input on ISO TC150/SC2/WG4 activities Contact: Jill Zajac
AAMI BP, Blood Pressure Monitoring Committee. The committee is seeking regulatory, user and general interest members to participate in the reaffirmation and future revision of AAMI BP22-1994 (R2016), Blood pressure transducers. Contact: Ladan Bulookbashi
AAMI CI, Cochlear Implants Committee. The committee is seeking industry, regulatory, and general interest members to participate in the reaffirmation and future revision of AAMI CI86-2017, Cochlear implant systems—Requirements for safety, functional verification, labeling and reliability reporting. Contact: Ladan Bulookbashi
AAMI CN, Small Bore Connectors Committee. The committee is seeking user, regulatory, and general interest members to participate in the reaffirmation and future revision of AAMI/ISO 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications; and in the expedited adoption of AAMI/ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications. Contact: Colleen Elliott
AAMI CV, Cardiac Valves Committee. The committee is seeking user, industry, and general interest/regulator members to participate in the US adoption of amendments to ISO 5840-1:2021, Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements; ISO 5840-2:2021, Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes; and ISO 5840-3:2021, 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 DPC-10, Needles Working Group. The committee is seeking user, industry, and general interest/regulator members to contribute to the development of the U.S. positions towards the revisions of ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices and ISO 7864:2016, Sterile hypodermic needles for single use. Contact: Jill Zajac
AAMI EQ-WG01, Healthcare Technology Management (HTM) Program Management working group. The working group is seeking general interest, industry, and regulatory members to participate in the revision of ANSI/AAMI EQ56:2013, Recommended practice for a medical equipment management program. Contact: Mike Miskell
AAMI EQ-WG04, Alternative Equipment Maintenance Working Group. The working group is seeking industry, regulatory and general interest members to participate in the development of AAMI EQ103/Ed.1, Alternative equipment maintenance in healthcare delivery organizations. Contact: Mike Miskell
AAMI EQ-WG05, HTM Education Programs Working Group. The working group 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: Mike Miskell
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 HF, High Frequency Therapeutic Device Committee The working group is seeking regulatory, user and general interest members to participate in the adoption project for IEC 60601-2-2:2017/AMD1:2023, Amendment 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. Contact: Ladan Bulookbashi
AAMI HIT-WG01, Health IT Risk Management Working Group. The working group is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI HIT1000-3/Ed.1, Safety and effectiveness of health IT software and systems—Part 3: Application of risk management. Contact: Chenai Maguwah
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.1, Health IT software and systems—Part 2: Application of quality systems principles and practices. Contact: Chenai Maguwah
AAMI HIT-WG03, Health IT Usability Working Group. The working group is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI HIT1000-4/Ed.1, Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering. Contact: Chenai Maguwah
AAMI IP, Implantable Infusion Pumps Committee The working group is seeking industry, regulatory, user and general interest members to participate in the adoption project for ISO 14708-04:2022 (Ed.2), Implants for surgery—Active implantable medical devices—Part 4: Implantable infusion pumps. Contact: Ladan Bulookbashi
AAMI MC, Mechanical Circulatory Support Systems Committee. The committee is seeking user, industry, and general interest/regulator members to participate in the development of documents under ISO/TC150/SC2/WG2 including the early revision of ISO 14708-5:2020, Implants for surgery — Active implantable medical devices — Part 5: Circulatory support devices. Contact: Jill Zajac
AAMI NS-WG02, Implantable neurostimulator Working Group The working group is seeking regulatory, user and general interest members to participate in the reaffirmation of ANSI/AAMI/ISO 14708-3:2017, Implants for surgery—Active implantable medical devices—Part 3: Implantable neurostimulators. Contact: Ladan Bulookbashi
AAMI NS-WG03, Transcutaneous electrical stimulator Working Group The working group is seeking industry, regulatory, user and general interest members to participate in the reaffirmation and future revision of AAMI NS4-2013 (R2017), Transcutaneous electrical nerve stimulators. Contact: Ladan Bulookbashi
AAMI QM-WG02, General aspects from medical devices This working group is seeking user and general interest/regulatory members to participate in the national adoption of ISO 20417, Medical devices — Information to be supplied by the manufacturer. Contact: Amanda Benedict
AAMI RD, Renal Disease and Detoxification Committee. 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 SM-WG03, Interoperability Working Group. The group is seeking general interest, regulatory, and users. The committee is developing a new American National Standard, SW114, Safe Remote Control of Medical Devices. Contact: Chenai Maguwah
AAMI SM-WG05, Medical Device Security Working Group. The group is seeking general interest, regulatory, and users to participate in the future revisions of AAMI TIR57, Principles for medical device security—Risk Management and AAMI TIR97, Principles for medical device security—Postmarket risk management for device manufacturers. Contact: Chenai Maguwah
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 new TIR, AAMI TIR115: Cloud – Guidance for the appropriate use of public cloud computing to enable medical device functions. Contact: Chenai Maguwah
AAMI ST-WG02, Radiation sterilization. The working group is seeking general interest, regulatory, and user members to contribute to development of AAMI CR513/Ed.1, Guidance on radiation validation and routine maintenance for single-use systems. Contact: Mike Miskell.
AAMI ST-WG03, Moist heat sterilization. The working group is seeking general interest, regulatory, and user members to contribute to development of a new TIR AAMI TIR116/Ed.1, Guidance on designation of a medical product to a device product family and acceptance of a product into a product family by equivalence using moist heat sterilization. Contact: Mike Miskell.
AAMI ST-WG06, Chemical Indicators Working Group. The working group is seeking user, regulatory and general interest members to contribute to development of the U.S. positions towards the revisions of several parts of the ISO 11140 series. Contact: Tommy Kim
AAMI ST-WG13, Washer-disinfectors Working Group. The working group is seeking user, regulatory and general interest members to contribute to development of the U.S. positions towards the revisions of ISO 15883-2, ISO 15883-3 and ISO 15883-7, and consideration of national adoptions of the revised standards. Contact: Tommy Kim
AAMI ST-WG45, Processing of tattoo machines and accessories in healthcare settings Working Group. The group is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI TIR117/Ed.1, Guidance for processing tattoo machines and accessories in the healthcare setting. Contact: Tommy Kim
AAMI ST-WG 61, Chemical Sterilants Hospital Practices Working Group. The group is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI TIR118/Ed.1, Guidance on ultraviolet (UV) disinfection for medical devices in health care facilities. Contact: Tommy Kim
AAMI TIB, Transfusion, Infusion, and Injection, and Blood Processing Equipment for Medical and Pharmaceutical Use Committee. 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 VP, Vascular Prostheses Committee. 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 VP-WG 01, Vascular Device-drug Combination Products Working Group. 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

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.

May 2023

AAMI ST-WG02, Radiation Sterilization Working Group (open meeting) 24 May 2023, 13:00h to 17:00h EST, web meeting. The WG will meet to discuss proposed US comments for ISO/DIS 11137‐1. Contact: Mike Miskell

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group (open meeting) 25 May 2023, 10:00h to 11:30h EST, web meeting. The WG will meet to discuss revisions to ANSI/AAMI PC76:2021. Contact: Ladan Bulookbashi

AAMI ST-WG01, Industrial Ethylene Oxide Sterilization working group (open meeting) 30 May 2023, 13:00h to 16:00h EST and 31 May 2023, 13:00h to 16:00h EST, web meeting. The WG will meet to discuss comments for ISO/DIS 11135. Contact: Tommy Kim

AAMI ID, Infusion Device Committee (open meeting) 31 May 2023, 1:30h to 3:30h EST, web meeting. The committee will meet to continue resolving comments on Working Draft-3 of AAMI/TIR 111 ED1, Infusion system performance related to occlusions and unintended boluses. Contact: Ladan Bulookbashi

June 2023

AAMI ST-WG01, Industrial Ethylene Oxide Sterilization working group (open meeting) 1 June 2023, 10:00h to 13:00h EST, web meeting. The WG will meet to discuss comments for ISO/DIS 11135. Contact: Tommy Kim

AAMI CP, Combination Products (open meeting) 6 June 2023 10:00h to 12:00h Eastern, web meeting. The committee will resolve comments for TIR 48 CDV2 Contact: Jill Zajac

AAMI SP, Sphygmomanometer Committee (open meeting) 7 June 2023, 1:00h to 3:00h EST, web meeting. The committee will meet to discuss National Adoption of ISO 81060-3:2022. Contact: Ladan Bulookbashi

AAMI TIB-WG04, Elastomeric parts, components and packaging working group (open meeting) 7 June 2023, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1^st Wednesday of every month, from 10:00h to 11:00h EST, to discuss TIR 112, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group (open meeting) 15 June 2023, 10:00h to 11:30h EST, web meeting. The WG will meet virtually the 3^rd Thursday of every month to discuss revisions to ANSI/AAMI PC76:2021. Contact: Ladan Bulookbashi

AAMI EQ, Medical Equipment Management Committee (open meeting) 19 June 2023, 16:00h to 17:00h EST, hybrid meeting. The Committee will meet to discuss the reaffirmation ballot of ANSI/AAMI EQ89:2015/(R)2023 and other AAMI EQ Committee/Working Group updates. Contact: Mike Miskell

AAMI EQ-WG01, HTM Program Management Working Group (open meeting) 19 and 20 June 2023, 17:00h to 20:00h and 11:00h to 15:00h EST respectively, hybrid meeting. The WG will meet to resolve comments for AAMI/CDV-2 EQ56. Contact: Mike Miskell

AAMI EQ-WG05, HTM Education Programs Working Group (open meeting) 20 June 2023, 11:00h to 15:00h EST, hybrid meeting. The WG will meet to resolve comments for AAMI/WD-1 EQ110. Contact: Mike Miskell

AAMI EQ-WG04, Alternative Equipment Maintenance Working Group (open meeting) 20 June 2023, 16:00h to 20:00h Eastern, hybrid meeting. The WG will meet to resolve comments for AAMI/WD-1 EQ103. Contact: Mike Miskell

AAMI COVID-19 response team (open meeting) 21 June 2023, 15:00h to 16:00h Eastern, web meeting. Discuss impacts of the end of the US public health emergency and other committee business. Contact: Colleen Elliott

AAMI AR, Anaesthetic and respiratory Committee and WGs (open meeting) 21 June 2023, 16:00h to 17:00h Eastern, web meeting. Discuss outcome of ISO/TC 121 plenary and affiliated meetings and other committee business. Contact: Colleen Elliott

AAMI RD, Renal Disease and Detoxification Committee (open meeting) 29 June 2023 8:00 to 16:00 Eastern, hybrid meeting. The committee will resolve comments for ISO 8637-1 and 8637-3 Contact: Jill Zajac

July 2023

AAMI TIB-WG04, Elastomeric parts, components and packaging working group (open meeting) 5 July 2023, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1^st Wednesday of every month, from 10:00h to 11:00h EST, to discuss TIR 112, Guidance for Closed System Transfer Device Testing with Hazardous Drugs (CSTD). Contact: Sam Alameda

AAMI BE and associated WGs - Biological Evaluation Standards week, (open meetings; hybrid – advanced registration REQUIRED) 18 –21 July 2023, 09:00h to 17:00h EST, Arlington, VA and web meetings. Contact: Chenai Maguwah

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility working group (open meeting) 20 July 2023, 10:00h to 11:30h EST, web meeting. The WG will meet virtually the 3^rd Thursday of every month to discuss revisions to ANSI/AAMI PC76:2021. Contact: Ladan Bulookbashi

September 2023

AAMI Fall 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in July 2023). 11-14 September 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards

International Standards

International Committee and Working Group Meetings

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

May 2023

ISO/TC 198/WG6, Chemical Indicators (closed meetings). Virtual, 18 May and 22-23 May 2023, 08:00h to 16:00h daily EST. Contact: Mike Miskell

September 2023

IEC/TC 62, Medical equipment, software, and systems, and affiliated SC and (J)WG meetings (closed meetings). Seoul, Korea, 11-22 September 2023, 09:00h to 17:00h daily local time. Contact: Hae Choe

ISO/TC150/SC2/WG5, Renal replacement, detoxification and apheresis (closed meetings). Zoom, 18-29 September 2023, 8:00h to 12:00h EST. Contact: Jill Zajac

October 2023

ISO/TC 194, Biological and clinical evaluation of medical devices and affiliated WG meetings (closed meetings). Arlington, US, 23-27 October 2023, 09:00h to 17:00h daily local time. Contact: Chenai Maguwah

November 2023

ISO/TC 121/SC2, Airways and related equipment and ISO/TC 121/SC6, Medical gas supply systems (closed meetings). Dublin, Ireland (tent.) 13-17 November 2023, 09:00h to 17:00h daily local time. 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.