AAMI Standards Monitor Online 27 May 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:
NEW! We have completed transitioning our standards groups to the NEW AAMI Committee Central platform! Information is available here.
NEWSWORTHY!! Europe recognizes ISO 14971:2019, Application of risk management to medical devices
With the recent May publication of Commission Implementing Decision 2022/757 in the Official Journal of the European Union, EN ISO 14971:2019 is labeled as “Harmonized” and listed to the European Union’s Medical Device Regulation (EU 2017/745). When a standard is Harmonized and listed in the Official Journal, manufacturers who comply with the standard are provided with a legal presumption that certain requirements in the referenced regulation have been satisfied. The specific requirements and the extent and limitations of that presumption are detailed in the accompanying European Annexes to the standard. More information is available here.
REAFFIRMED! AAMI TIR67:2018/(R)2022, Promoting safe practices pertaining to the use of sterilant and high-level disinfectant chemicals in healthcare facilities is available here.
REAFFIRMED! AAMI TIR68:2018/(R)2022, Low and intermediate level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental s surfaces is available here.
PUBLISHED! ANSI/AAMI 2700-2-1:2022, Medical devices and medical systems—Essential safety and performance requirements for equipment comprising the patient-centric integrated clinical environment (ICE): Part 2-1: Particular requirements for forensic data logging is available here.
PUBLISHED! ANSI/AAMI HIT1000-1:2022, Safety and effectiveness of health IT software and systems—Part 1: Fundamental concepts, principles, and requirements is available here.
PUBLISHED! AAMI TIR100:2021, End-to-end microbiological quality and sterility assurance is available here.
PUBLISHED! AAMI TIR104:2022, Guidance on transferring health care products between radiation sterilization source is available here.
PUBLISHED! AAMI CR34971:2022, Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning is available here.
The AAMI Standards Insider webinar series was last held on Thursday, May 19th from 1:00-2:00 PM ET. This one-hour FREE webinar provided news and updates about AAMI’s standards program and portfolio. The next webinar will be held in August (date TBD), from 1:00-2:00 PM ET. Register here.
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.
Published documents proposed for reaffirmation can be purchased from the AAMI Store.
AAMI/ISO CDV-1 11138-8, Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation time for a biological indicator (identical national adoption of ISO 11138-8:2021). Specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. Contact: Jody Allen
AAMI/ISO 11138-1, Sterilization of health care products—Biological indicators—Part 1: General requirements (reaffirmation of an American National Standard). Specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. Contact: Jody Allen
AAMI/ISO 11138-2, Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes (reaffirmation of an American National Standard). Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
Contact: Jody Allen
AAMI/ISO 11138-3, Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes (reaffirmation of an American National Standard). Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. Contact: Jody Allen
AAMI/ISO 11138-4, Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes (reaffirmation of an American National Standard). Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 20 °C to 180 °C.
Contact: Jody Allen
AAMI/ISO 11138-5, Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (reaffirmation of an American National Standard). Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. Contact: Jody Allen
AAMI/ISO CDV-1 15223-1, Medical devices–Symbols to be used with information to be supplied by the manufacturer—Part 1: General requirements (identical national adoption of ISO 15223-1:2021, to supersede ANSI/AAMI/ISO 15223-1:2016). Specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on the medical device itself, on its packaging or in the accompanying information. The requirements of this document are not intended to apply to symbols specified in other standards. 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: Jody Allen
AAMI SM-WG10, Cloud Computing. The AAMI Standards Board has approved the formation of a new working group under AAMI SM, Software and Information Technology, and authorized the group to begin work on a Technical Information Report based on the approved AAMI CR510:2021, Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices. This new WG is seeking members from the General interest, Industry, Regulatory and User categories to join.
Contact: Ovidiu Munteanu
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. We are currently looking to schedule a meeting the week of 6-10 June, if interested in attending please email me. Contact: Sam Alameda
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 SU, Sustainability Committee (open meeting). 25 May 2022, 11:30h to 13:00h EDT, Web meeting. Contact: Chenai Maguwah
AAMI TIB-WG04 Committee (open meeting). 8 June 2022, 10:30h to 12:00h EDT, web meeting. Contact Sam Alameda
AAMI SP, Sphygmomanometer Committee (open meeting). 6 June 2022, 11:00h to 12:30h EDT, web meeting. Contact: Ladan Bulookbashi
AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). 6 June 2022, 13:00h to 17:00h CST and 7 June 2022, 08:00h to 17:00h CST, San Antonio, TX and web meeting. Contact: Jody Allen
AAMI Fall 2022 Sterilization Standards Week (open meetings – advance registration REQUIRED; registration to open in early July). 12-15 September 2022, 08:00h to 17:00h ET, Arlington, VA and web meetings. Contact: firstname.lastname@example.org
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.
ISO/TC 150/SC 6/JWG 1, Cardiac pacemakers and implantable defibrillators (closed meeting), 24 May 2022, 9:00h to 17:00h EDT, hybrid meeting. Contact: Ladan Bulookbashi
July 2022ISO/TC 121, Anaesthetic and respiratory equipment and affiliated groups (closed meetings), 11-15 July 2022, St. John’s, Newfoundland, Canada. 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 email@example.com for more information about the project or participation on the committee.