AAMI Standards Monitor Online 17 March 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:
REAFFIRMED! ANSI/AAMI EQ89:2015/(R)2023, Guidance for the use of medical equipment maintenance strategies and procedures. Click here for more information.
The next AAMI Standards Insider webinar will be on Thursday, May 18th 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 recent March 2nd session - will be available on the webpage. Check back soon!
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 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 (proposed new American National 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/ISO 13004, Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD (identical national adoption of ISO 13004:2022) Specifies a method or substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10−6 or less or radiation sterilization o health care products. This document also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose. Contact: Tommy Kim
AAMI/ISO 20417, Medical devices — Information to be supplied by the manufacturer (identical national adoption of ISO 20417:2021) Specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. Contact: Amanda Benedict
AAMI/ISO 80369-5, Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications (reaffirmation of an American National Standard). specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in limb cuff inflation applications of medical devices and accessories. Limb cuff inflation applications include connections between a sphygmomanometer and its cuff. Contact: Colleen Elliott
AAMI/ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications (expedited adoption of ISO 80369-7:2021). This document specifies dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections in intravascular applications or hypodermic connections in hypodermic applications of medical devices and accessories. Contact: Colleen Elliott
AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use Committee. The committee is working on an AAMI Consensus Report (CR) for Guidance for Closed System Transfer Device Testing with Hazardous Drugs. 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 holds monthly meetings (1st Wednesday of every month, 10:00h to 11:00h EST). 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 (firstname.lastname@example.org) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
AAMI COVID-19 Response team (open meeting) 29 March, 15:00h to 16:00h, web meeting. Contact: Colleen Elliott
AAMI TIB-WG04, Elastomeric parts, components and packaging working group (open meeting) 5 April 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, to discuss CR112. Contact: Sam Alameda
AAMI HE, Human Factors Engineering Committee (open meeting) 11 to 13 April 2023, 09:00h to 17:00h EST, Arlington, VA. Contact: Hae Choe
AAMI TIB-WG04, Elastomeric parts, components and packaging working group (open meeting) 3 May 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 Software, Health Information Technology, and Artificial Intelligence standards committees - plenary meeting to exchange information on work programs (open meeting) 9 May 2023, 13:00h to 15:30h EST, web meeting. Contact: Chenai Maguwah
AAMI PC, Cardiac Rhythm Management Device Committee (open meeting) 18 May 2023, 10:00h to 13:00h EST, web meeting. Contact: Ladan Bulookbashi
AAMI AR, Anaesthetic and respiratory Committee and WGs (open meeting) 21 June 2023, 16:00h to 17:00h EST, web meeting. Contact: Colleen Elliott
AAMI BE and associated WGs - Biological Evaluation StandarWeek, (open meetings; hybrid) 17 –21 July 2023, 08:00h to 17:00h EST, Arlington, VA and web meetings. Contact: Chenai Maguwah
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
International Committee and Working Group Meetings
Information on draft international standards under ballot can be found in ANSI Standards Action.
ISO/TC 150/SC2/WG5, Renal replacement, detoxification and apheresis (closed meetings). Virtual (tent.) 17-20 April 2023, 08:00h to 12:00h EST. Contact: Jill Zajac
ISO/TC 121, Anaesthetic and respiratory equipment and affiliated SC and (J)WG meetings (closed meetings). London, UK, 15-19 May 2023, 09:00h to 17:00h daily local time. Contact: Colleen Elliott
ISO/TC 150/SC6/JWG1 (Joint with IEC/SC 62D WG), Cardiac pacemakers and implantable defibrillators (closed meetings). 18 May 2023, 14:00h to 17:00h EST, web meeting. Contact: Ladan Bulookbashi
IEC/TC 62, Medical equipment, software, and systems, and affiliated SC and (J)WG meetings (closed meetings). Seoul, Korea, 11-22 September 2023, 09:00h to 17:00h daily local time. Contact: Hae Choe
ISO/TC 194, Biological and clinical evaluation of medical devices and affiliated WG meetings (closed meetings). Arlington, US, 23-27 October 2023, 09:00h to 17:00h daily local time. Contact: Chenai Maguwah
ISO/TC 121/SC2, Airways and related equipment and ISO/TC 121/SC6, Medical gas supply systems (closed meetings). Dublin, Ireland (tent.) 13-17 November 2023, 09:00h to 17:00h daily local time. 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.