AAMI Standards Monitor Online 14 October 2022
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:
NEWSWORTHY!! AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation will return “in-person” on 18-19 October 2022. Click here for more information.
NEW! We have completed transitioning our standards groups to the NEW AAMI Committee Central platform! Information is available here.
REAFFIRMED! AAMI TIR35: 2016/(R)2021, Sterilization of health care products—Radiation sterilization—Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits is available here.
PUBLISHED! ANSI/AAMI ST98:2022, Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices is available here.
PUBLISHED! AAMI/ISO TIR11137-4:2022, Sterilization of health care products—Radiation—Part 4: Guidance on process control is available here.
The next AAMI Standards Insider webinar will be held on Thursday, November 17th, from 1:00-2:00 PM ET. This one-hour FREE webinar will provide news and updates about AAMI’s standards program and portfolio. Registration for the upcoming webinar and recordings of past webinars in the series are available here.
If you would like to comment on one of the draft documents listed below, contact the individual indicated by email to receive a PDF copy of the draft. These copies are free.
Published documents proposed for reaffirmation can be purchased from the AAMI Store.
AAMI/ISO 11137-3, Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects of development, validation and routine control (reaffirmation of an American National Standard). This part of ISO 11137 gives guidance on the requirements in ISO 11137 parts 1 and 2 and in ISO/TS 13004 relating to dosimetry. Dosimetry procedures related to the development, validation and routine control of a radiation sterilization process are described. Contact: Amanda Benedict
AAMI/ISO 16142-2, Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards(reaffirmation of an American National Standard). Considers and identifies certain significant standards and guides that can be useful in the assessment of conformity of medical devices with recognized essential principles of safety and performance. Contact: Amanda Benedict
AAMI ST90, Processing of Health Care Products—Quality Management Systems For Processing In Health Care Facilities(reaffirmation of an American National Standard). This document specifies minimum requirements for quality management systems (QMSs) to effectively, efficiently, and consistently process (transport, clean, decontaminate, disinfect, inspect, package, sterilize, and store) medical devices to prevent adverse patient events and nonmanufacturer-related device failures. Contact: Jody Allen
AAMI HE75, Human factors engineering—Design of medical devices (revision of an American National Standard). This standard addresses a broad range of human factors engineering topics as they relate to the design and evaluation of medical devices. This document is expected to be useful to human factors and usability engineering specialists, software developers, industrial, biomedical, mechanical, and electrical engineers and other development personnel. There are significant updates being proposed in this revision of the 2009 document. Contact: Hae Choe
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. Contact: Sam Alameda
AAMI HIT-WG01, Health IT Risk Management Working Group. The working group will be moving to update and convert AAMI HIT1000-3/Ed.1, Safety and effectiveness of health IT software and systems—Part 3: Application of risk management from a provisional standard to a full American National Standard. The standard will identify the core concepts and principles needed to maintain safe and effective health IT software and systems to estimate and evaluate the associated risks, to control
these risks, and to monitor the effectiveness of the controls. This WG is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI HIT1000-3/Ed.1.
Contact: Chenai Maguwah
AAMI HIT-WG02, Health IT Quality Systems Working Group. The working group is developing AAMI HIT1000-2/Ed.1, Health IT software and systems—Part 2: Application of quality systems principles and practices. This standard will specify a process to build on the principles in existing quality systems principles and practices, as well as identify the specific roles and responsibilities needed to ensure health IT safety and quality as well as patient safety hazards associated with health IT software and systems, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. This WG is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI HIT1000-2/Ed.1. Contact: Chenai Maguwah
AAMI HIT-WG03, Health IT Usability Working Group. The working group will be moving to updated and convert AAMI HIT1000-4/Ed.1, Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering from a provisional standard to a full American National Standard. The standard will describe an approach to developing and validating a health IT system’s user interface so that such systems are safe and effective. This WG is seeking industry,
user, general interest, and regulatory members to participate in the development of AAMI HIT1000-4/Ed.1.
Contact: Chenai Maguwah
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 (email@example.com) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
AAMI BE US TAG Committee for ISO/TC 194 (open meeting; hybrid). 25 October 2022, 13:00h to 16:00h EST. Register here: AAMI BE, U.S. TAG for ISO/TC 194 Meeting - 25 October 2022.
Contact: Ovidiu Munteanu
AAMI CN, Small-bore Connectors Committee (open meeting). 27 October 2022, 10:00h to 13:00h EST, web meeting. Contact: Colleen Elliott
AAMI RD, Renal Disease and Detoxification Committee Infusion Device Committee (open meeting; hybrid). 6-7 November 2022, DaVita Airport Dialysis/Training center Orlando FL, web meeting. More details to follow. Contact: Jill Zajac
AAMI AR, Anaesthetic and respiratory equipment Committee and AR/WGs (open meeting).
7 December 2022, 16:00h to 17:00h, web meeting. Contact: Colleen Elliott
AAMI Spring 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in January 2023). 20-24 March 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards
AAMI Fall 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in July 2023). 18-22 September 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization 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.
IEC/TC 62, Electrical equipment in medical practice, and subcommittees 62A, 62B, 62C, and 62D (closed meeting). 24 October-4 November 2022, 08:00h to 17:00h EST, Plenary meeting, and meetings of affiliated working groups. Contact: Hae Choe
ISO/TC 198, Sterilization of health care products and meetings of affiliated groups (closed meetings). 5-9 December 2022, 09:00h to 17:30h EST, Plenary meeting, and meetings of affiliated working groups. Contact: Amanda Benedict
ISO/TC 210, Quality management and corresponding general aspects for medical devices (closed meetings). 12-16 December 2022, 09:00h to 17:30h EST, Plenary meeting, and meetings of affiliated working groups. Contact: Amanda Benedict
ISO/TC 150 Implants for surgery (closed meetings). 6-7 December 2022, 08:00h to 10:00h EST, Plenary meeting. Contact: Jill Zajac
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 firstname.lastname@example.org for more information about the project or participation on the committee.