AAMI Standards Monitor Online 5 April 2021
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:
Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. Purchase here.
Sterilization Of Health Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices was reaffirmed February 11, 2021.
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, anesthetic 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, anesthetic 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
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.
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:
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
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.
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
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 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
Artificial Intelligence Committee (open web meeting) 2 April 2021, 10:30h to 12:30h ET. Virtual meeting. Contact: Emily Hoefer
Luer activated valves working group (open web meeting) 16 April 2021, 10:00h to 16:00h ET. Virtual meeting. Contact: Colleen Elliott
AAMI/CP, Combination products (open meeting), 22 April 2021, 13:00 to 17:00 h ET, Teams meeting. Contact: Cliff Bernier
Steam Sterilization Hospital Practices Working Group (open web meting). 28 April 2021, 09:00h to 17:00h ET. Virtual meeting. Contact: Amanda Benedict
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: Standards Department
Renal Disease and Detoxification Committee (open web meeting). 7 May 2021, 11:00h to 17:00h ET. Contact: Cliff Bernier
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
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.
April 2021
ISO/TC 150/SC 2/WG 8, Cardiac occluders (closed meeting). 5 to 7 April 2021, Zoom meeting. Contact: Cliff Bernier
ISO/TC 198/WG 16, Vaporized hydrogen peroxide sterilization (closed meeting), 8, 13, 15, 20 April 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
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
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.
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.
