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NEW! ANSI/AAMI/ISO 10993-16:2017, Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. Purchase 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.

Comments due April 26, 2021

AAMI/ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (reaffirmation of an American National Standard). This standard specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g., instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Contact: Amanda Benedict

AAMI/ISO 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (reaffirmation of an American National Standard). This standard specifies performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (e.g., instruments and porous loads). Contact: Amanda Benedict

AAMI/ISO 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests (reaffirmation of an American National Standard). This standard specifies the requirements for an indicator and alternative test system used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.. Contact: Amanda Benedict

AAMI ST15883-2, Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc (reaffirmation of an American National Standard). This standard specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anaesthetic equipment, bowls, dishes and receivers, utensils and glassware. Contact: Amanda Benedict

AAMI ST15883-3, Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (reaffirmation of an American National Standard). This standard specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. Contact: Amanda Benedict

AAMI/ISO 17664-2, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (expedited national adoption of an international standard). This standard specifies requirements for the information to be provided by the medical device manufacturer for the processing of medical devices not intended for direct patient contact. This includes information for processing prior to use or reuse of the medical device. Contact: Amanda Benedict

AAMI/ISO 20857, Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (reaffirmation of an American National Standard). This standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. Contact: Amanda Benedict

Comments due May 17, 2021

AAMI ST15883-1, Washer-disinfectors, Part 1: General requirements, terms and definitions and tests & A1 & A2 (reaffirmation of an American National Standard and amendments). This standard specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. Contact: Amanda Benedict

AAMI SW96, Standard for medical device security — Security risk management for device manufacturers (proposed new American National Standard). This standard provides requirements and guidance when addressing design, production and post-production security risk management within the risk management framework defined by ANSI/AAMI/ISO 14971. While it is based on the ANSI/AAMI/ISO 14971 framework for medical device risk management, most concepts are applicable to any healthcare product, including digital health, that requires the management of security. Contact: Ovidiu Munteanu

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: Ovidiu Munteanu.

AAMI QM-WG01, Application of Quality Systems to Medical Devices Working Group. The working group is working on the development of AAMI CR510, Consensus Report on Compliant Use of Cloud Computing for Quality Systems and Medical Devices. This Consensus Report will provide guidance to multiple stakeholders regarding the appropriate and compliant use of cloud computing both as a component of medical devices and in support of quality systems. Contact: Joe Lewelling.

AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. The committee has recently approved development of an AAMI Technical Information Report (TIR), 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 Close 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. Contact: Jeff Linder.

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 Committee. 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: Amanda Benedict.
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: Amanda Benedict.
AAMI ST-WG12, Instructions for reusable device reprocessing. The working group is seeking user, regulatory and general interest members to participate in the national adoptions of the ISO 17664 series. Contact: Amanda Benedict.
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: Amanda Benedict.
AAMI ST-WG42, Dry heat sterilization. The working group is seeking user, regulatory and general interest members to participation in the reaffirmation of AAMI/ISO 20857, Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices. Contact: Amanda Benedict.
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: Amanda Benedict.
AAMI ST-WG84, Endoscope reprocessing. The working group is seeking regulatory and general interest members to participate in the development of AAMI ST91/Ed.2, Flexible and semi-rigid endoscope processing in health care facilities and AAMI TIR99/Ed.1, Dilators, transesophageal and ultrasound probes processing in health care facilities. Contact: Amanda Benedict.
AAMI ST-WG 91, Resistometers. The working group is seeking user, industry, and regulatory/general interest stakeholders to participate in the US adoption of ISO 18472:2018, Sterilization of health care equipment – Biological and chemical indicators – Test equipment. Contact: Cliff Bernier.
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 US 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: Jeff Linder.
AAMI/CV, Cardiac valves. The committee is seeking user, industry, and general interest/regulator members to participate in the US 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: Cliff Bernier.
AAMI/VP, Vascular Prostheses. The committee is seeking user, industry, and general interest/regulator members to participate in the US adoption of ISO 25539-2:2020, Cardiovascular implants — Endovascular devices — Part 2: Vascular stetnts; the revision of ISO 25539-3, Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters; and the development of ISO 25539-4, Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices. Contact: Cliff Bernier
AAMI/BG, Blood/Gas Exchange Device Committee. 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: Cliff Bernier
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 requirements and the revision of ISO/TR 12417-2:2017, Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information. Contact: Cliff Bernier
AAMI/VI, Cardiovascular absorbable implants. The committee is seeking user, industry, and general interest/regulator members to participate in the revision of ISO/TS 17137:2019, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants. Contact: Cliff Bernier
AAMI/CO, Cardiac Occluders. The committee is seeking user, industry, and general interest/regulator members to participate in the development of ISO 22679, Cardiovascular implants — Transcatheter cardiac occluders. Contact: Cliff Bernier
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: Cliff Bernier
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: Emily Hoefer
AAMI AI, Artificial Intelligence Committee. 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: Emily Hoefer
AAMI/SM-WG05, Medical Device Security Working Group – seeking general interest, reg/govt 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/EV-WG05, Hospital Beds Working Group- 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

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.

April 2021

Industrial EO Sterilization Working Group (open web meetings). 26 and 30 April 2021, 13:00h to 16:00h ET. Virtual meeting. Contact: Amanda Benedict

Steam Sterilization Hospital Practices Working Group (open web meting). 28 April 2021, 09:00h to 17:00h ET. Virtual meeting. Contact: Amanda Benedict

Water Quality for Reprocessing Medical Devices Working Group (open web meeting). 29 April 2021, 13:00h to 17:00 h ET. Virtual meeting. Contact: Emily Hoefer

May 2021

Endoscope Reprocessing Working Group (open web meeting). 4/6/12 May 2021, 11:00h to 14:00h ET. Contact: Emily Hoefer

Cardiac Rhythm Management Devices Committee (open web meeting). 6 May 2021, 11:00h to 13:30h ET. Contact: Ladan Bulookbashi

Renal Disease and Detoxification Committee (open web meeting). 7 May 2021, 11:00h to 17:00h ET. Contact: Cliff Bernier

Hospital Beds Working Group (open web meeting). 7 May 2021, 13:00h to 15:00h ET. Contact: Ladan Bulookbashi

September 2021

AAMI Sterilization Standards meetings (open meetings). 13-17 September 2021, 08:00h to 17:00h ET. Schedule of meetings TBD. AAMI, Arlington, VA. Contact: Amanda Benedict

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.

April 2021

IEC/TC 62 and subcommittees, Electrical equipment in medical practice (closed meeting), 12 to 23 April 2021, Zoom meeting. Contact: Hae Choe

ISO/TC 198/WG 9, Aseptic processing (closed meeting), 29 April 2021, 12:00 h to 16:00 h CEST, Zoom meeting. Contact: Amanda Benedict

May 2021

ISO/TC 198/WG 2, Radiation sterilization (closed meeting), 26 May 2021, 10:00 h to 12:00 h EST, Zoom meeting. Contact: Amanda Benedict

June 2021

ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 29 June 2021, 13:00 h to 15:00 h IST, Zoom meeting. Contact: Amanda Benedict

July 2021

ISO/TC 121, Anaesthetic and respiratory equipment (closed meeting), 16 July 2021, Zoom meeting. 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.