AAMI Standards Monitor Online 20 February 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.
Published documents proposed for reaffirmation can be purchased from the AAMI Store.
Comments due March 15, 2021
AAMI/ISO 13408-5, Aseptic processing of health care products - Part 5: Sterilization in place (reaffirmation of an American National Standard). This standard specifies the general requirements for sterilization in place (SIP) applied to product contact surfaces of the equipment used in the manufacture of sterile health care products by aseptic processing and offers guidance on qualification, validation, operation and control. This document applies to processes where sterilizing agents are delivered to the internal surfaces of the equipment that can come in contact with the product. 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: Amanda Benedict.
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.
February 2021
Industrial Moist Heat Sterilization Working Group (open web meeting). 22 and 23 February 2021, 12:00h to 15:00h ET. Virtual meetings. Contact: Amanda Benedict.
HIT Risk Management Working Group (open web meeting). 24 February 2021, 13:30h to 15:00h ET. Virtual meeting. Contact: Emily Hoefer
Small-bore Connectors Committee (open web meeting). 25 February 2021, 10:00h to 11:00h ET. Contact: Colleen Elliott.
March 2021
AAMI COVID-19 Response Team (open web meeting). 17 March 2021, 15:00h to 16:00h ET. Contact: Colleen Elliott.
AAMI Sterilization Standards meetings (open web meetings). 22 March through 1 April 2021, 08:00h to 17:00h ET. Schedule of meetings in development. Virtual meetings. Contact: Amanda Benedict.
Radiation Sterilization Working Group (open web meeting). 22 March 2021, 13:00h to 17:00h ET. Virtual meeting. Contact: Amanda Benedict.
Industrial EO Sterilization Working Group (open web meeting). 23 March 2021, 13:00h to 17:00h ET. Virtual meeting. Contact: Amanda Benedict.
Compatibility of Material Subject to Sterilization Working Group (open web meeting). 26 March 2021, 10:00h to 12:00h ET. Virtual meeting. Contact: Cliff Bernier.
Assurance of Sterility Working Group (open web meeting). 26 March 2021, 13:00h to 17:00h ET. Virtual meeting. Contact: Amanda Benedict.
Water Quality fo Reprocessing Medical Devices Working Group (open web meeting). 29 March 2021, 11:30h to 17:00h ET. Virtual meeting. Contact: Amanda Benedict.
Microbiological Methods Working Group (open web meeting). 30 March 2021, 13:00h to 17:00h ET. Virtual meeting. Contact: Amanda Benedict.
Cleaning of Reusable Medical Devices Working Group (open web meeting). 31 March 2021, 11:30h to 15:30h ET. Virtual meeting. Contact: Amanda Benedict.
April 2021
Sterilization Standards Meetings Closing Plenary/US TAG to ISO/TC 198 (open web meeting). 1 April 2021, 14:00h to 16:00h ET. Virtual meeting. Contact: Amanda Benedict.
May 2021
Cardiac Rhythm Management Devices (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 web 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.
February 2021
ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 23 February 2021, 08:00 h to 10:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 8, Microbiological methods (closed meeting), 24 February 2021, 09:00 h to 10:00 h ET, Zoom meeting. Contact: Amanda Benedict
March 2021
ISO/TC 198/WG 16, Vaporized hydrogen peroxide sterilization (closed meeting), 2, 4, 9, 11, 16, 18 March 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 4, Biological indicators (closed meeting), 8 March 2021, 09:00 h to 12:00 h ET, Zoom meeting. Contact: Amanda Benedict
ISO/TC 198/WG 2, Radiation sterilization (closed meeting), 11 March 2021, 11:00 h to 12:00 h ET, Zoom meeting. Contact: Amanda Benedict
April 2021
ISO/TC 150/SC 2/WG 8, Cardiac occluders (closed meeting). 5 to 7 April 2021, Zoom meeting. Contact: Cliff Bernier
IEC/TC 62 and subcommittees, Electrical equipment in medical practice (closed meeting), 12 to 23 April 2021, Zoom meeting. Contact: Hae Choe
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.
