AAMI Standards Monitor Online 3 February 2023
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! ANSI/AAMI PB70:2022 contains crucial information for manufacturers and users of personal protective equipment (PPE) in healthcare. Learn more.
PUBLISHED! ANSI/AAMI PB70:2022, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. Click here for more information.
PUBLISHED! Be sure to check back in the coming weeks on publication of ANSI/AAMI/ISO 18472:2022, Sterilization of health care products—Biological and chemical indicators—Test equipment.
The next AAMI Standards Insider webinar will be held on Thursday, February 16th from 1:00-2:00 PM ET. The one-hour FREE webinar provides news and updates about AAMI’s standards program and portfolio. Registration for the upcoming webinars and recordings of past webinars in the series – including the November 17th session - will be available on the webpage. Check back soon!
AAMI EQ89, Guidance for the use of medical equipment maintenance strategies and procedures (reaffirmation of an American National Standard) This standard is intended to provide basic information to health care technology management professionals by identifying and describing in general various maintenance strategies and methods for efficient, effective, and timely maintenance of medical equipment in health care facilities. The standard neither mandates nor requires that any of these specific strategies be used, but instead discusses in general the uses of these methods and their potential advantages and disadvantages. Contact: Michael Miskell
AAMI 80369-3:2016, Small-bore connectors for liquids and gases in healthcare applications: Part 3: Connectors for enteral applications and AAMI 80369-3:2016/Amd1:2019 (reaffirmation of an American National Standard). This document Specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories. Contact: Colleen Elliott
AAMI ST108, Water for the processing of medical devices (new Standard) This standard covers the selection and maintenance of effective water quality suitable for processing medical devices. It provides guidelines for selecting the water quality necessary for the processing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations. Contact: Tommy Kim
AAMI BP22-1994 (R2016), Blood pressure transducers (reaffirmation of an American National Standard). This standard provides performance and safety requirements for transducers, including cables, designed for blood pressure measurements through an indwelling catheter or direct puncture, and provides disclosure requirements to permit the user to determine the compatibility between the transducer and blood pressure monitor. This standard is a combined revision of two American National Standards (ANSI/AAMI BP22-1986 and ANSI/AAMI BP23-1986.) Contact: Ladan Bulookbashi
AAMI CI86-2017, Cochlear Implant Systems: Requirements for Safety, Functional Verification, Labeling and Reliability Reporting (reaffirmation of an American National Standard). This standard establishes minimum requirements for those active implantable medical devices known as cochlear implants or cochlear prostheses, which are intended to treat hearing impairment by means of electrical stimulation of the cochlea. Devices that treat hearing impairment other than by including electrical stimulation of the cochlea are not covered by this standard. This standard applies to the electrical stimulation component(s) of combination devices that treat hearing impairment using multiple means, including electrical stimulation. The tests specified in this standard are industry-accepted tests and are to be carried out on samples of devices to show compliance. This standard is also applicable to non-implantable parts and accessories of the devices, including fitting and diagnostic components. General and specific requirements are provided with regard to design verification, post-implantation device testing, reliability assessment and reporting, packaging and labeling, protections of the patient associated with design issues and device malfunctions, and protections of the device associated with environmental challenges arising from transport, storage, handling during implantation, unrelated medical treatments, and normal use. Contact: Ladan Bulookbashi
AAMI NS4-2013 (R2017), Transcutaneous electrical nerve stimulators (reaffirmation of an American National Standard). This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical stimulators (including TENS) intended for use in the treatment of pain syndrome. Also covered are labeling requirements for patient leads and electrodes. Contact: Ladan Bulookbashi
AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use Committee. The committee has recently approved the change of AAMI Technical Information Report (TIR) on Guidance for Closed System Transfer Device Testing with Hazardous Drugs to a Consensus Report, until further data is available. This CR 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 CR112. The group has begun having monthly meetings (1st Wednesday of every month, 10:00h to 11:00h EST), and the next meeting is February 1st. 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/TIB-WG04, Elastomeric parts, components and packaging (open meeting) 1 February 2023, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1st Wednesday of every month, from 10:00h to 11:00h EST. Contact: Sam Alameda
AAMI/ID, Infusion Device (open meeting) 6 February 2023, 13:00h to 15:00h EST, web meeting. Contact: Ladan Bulookbashi
AAMI/AR and WGs, Anaesthetic and respiratory equipment (open meeting) 15 February 2023, 16:00h to 17:00h, web meeting. Contact: Colleen Elliott
AAMI/TIB-WG04, Elastomeric parts, components and packaging (open meeting) 1 March 2023, 10:00h to 11:00h EST, web meeting. The WG will meet virtually the 1st Wednesday of every month, from 10:00h to 11:00h EST. Contact: Sam Alameda
AAMI Spring 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in February 2023). 20-23 March 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards
U.S. TAG to ISO/TC 198 (AAMI Sterilization Standards Committee) (open meeting; hybrid – advanced registration REQUIRED; registration to open in February 2023). 23 March 2023, 13:00h to 15:00h EST, Arlington, VA, and web meeting. Contact: Sterilization Standards
AAMI Fall 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in July 2023). 11-14 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.
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care (closed meeting).
2 February 2023, 17:00h to 20:00h EDT, Plenary 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 firstname.lastname@example.org for more information about the project or participation on the committee.