AAMI Standards Monitor Online 2 September 2022

Standards Monitor Online

About Standards Monitor Online

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:

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STANDARDS UPDATE

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.

Publications

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.

PUBLISHED! ANSI/AAMI/IEC 60601-1-2:2014 & A1:2021, Medical electrical equipment—Part 1-2: General requirements for basic safety and essential performance—Collateral standard: Electromagnetic disturbances—Requirements and tests, including Amendment 1, is available here.

PUBLISHED! ANSI/AAMI/IEC 60601-1-8:2006 & A1:2013 & A2:2021, Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, including Amendments 1 and 2, is available here.

PUBLISHED! ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021, Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment, including Amendment 1, is available here.

PUBLISHED! ANSI/AAMI HA60601-1-11:2015 & A1:2021; IEC 60601-1-11:2015 MOD, Medical electrical equipment—Part 1-11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, including Amendment 1, is available here.

PUBLISHED! ANSI/AAMI ES60601-1:2005 & A1:2012 & A2:2021; IEC 60601-1:2005 MOD, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, including Amendments 1 and 2, is available here.

AAMI Standards Insider

The AAMI Standards Insider webinar series was last held on August 18^th. This one-hour FREE webinar provided news and updates about AAMI’s standards program and portfolio. The next webinar will be held on Thursday, November 17^th, from 1:00-2:00 PM ET. Registration for upcoming webinars and recordings of past webinars are available here.

National Standards

AAMI Call for Comments

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.

Comments due 12 September 2022

ANSI/AAMI ST79:2017 & A1:2020, A2:2020, A3:2020, & A4:2020, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (reaffirmation of an American National Standard and amendments). This document includes guidance for sterile processing facility design, personnel, receiving, transporting, handling, cleaning, decontamination, preparation, packaging, steam sterilization of reusable medical devices, quality process improvement and new product evaluation. Contact: Amanda Benedict

Comments due 26 September 2022

AAMI/ISO 11737-1:2018/A1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (proposed amendment to an American National Standard). This amendment revises B.3.3.4 and corrects formula B.1.
Contact: Amanda Benedict

AAMI CDV-2 ST108, Water for the processing of medical devices (proposed new American National 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: Jody Allen

AAMI CDV-1 ST24, General-purpose ethylene oxide sterilizers with automated process control and ethylene oxide sterilant sources intended for use in health care facilities (revision of an American National Standard). Covers minimum labeling, safety, performance, and testing requirements for ethylene oxide sterilizers that are intended for general-purpose use in health care facilities and that have automatic controls. It also covers labeling, product composition, and container requirements for ethylene oxide sterilant sources, as well as labeling, performance, safety, and installation requirements for ethylene oxide emission control systems. Contact: Jody Allen

Comments due 17 October 2022

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

New Work

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

Consensus Body Members Needed

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:

User

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

Industry

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.

Regulatory

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

General interest

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 EQ, Medical equipment management. The committee is seeking industry, regulatory and general interest members to participate in the development of AAMI EQ110/Ed.1, Guidance for health care technology management education programs. Contact: Jody Allen
AAMI ST-WG06, Chemical Indicators. The working group is seeking user, regulatory and general interest members to participate in the reaffirmations of the national adoptions of several parts of the ISO 11140 series . Contact: Jody Allen
AAMI ST-WG13, Washer-disinfectors. The working group is seeking user, regulatory and general interest members to participate in the reaffirmations of AAMI ST15883-2 and AAMI ST15883-3.
Contact: Jody Allen
AAMI ST-WG84, Endoscope Reprocessing. The working group is seeking regulatory and general interest members to participate in the development of AAMI TIR99/Ed.1, Dilators, transesophageal and ultrasound probes processing in health care facilities. Contact: Jody Allen
AAMI TIB, Transfusion, Infusion, and Injection, and Blood Processing Equipment for Medical and Pharmaceutical Use. The committee and its affiliated working groups are seeking user, industry, and general interest/regulator members to participate in developing the U.S. position towards documents under development in ISO/TC 76, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use, and other projects. Contact: Sam Alameda
AAMI CV, Cardiac Valves. The committee is seeking user, industry, and general interest/regulator members to participate in the U.S. adoption of ISO 5840-1:202x, Cardiovascular implants—Cardiac valve prostheses—Part 1: General requirements; ISO 5840-2:202x, Cardiovascular implants—Cardiac valve prostheses—Part 2: Surgically implanted heart valve substitutes; ISO 5840-3:202x, Cardiovascular implants — Cardiac valve prostheses—Part 3: Heart valve substitutes implanted by transcatheter techniques; and the revision of ISO 5910:2018, Cardiovascular implants and extracorporeal systems—Cardiac valve repair devices. Contact: Jill Zajac
AAMI VP, Vascular Prostheses. The committee is seeking user, industry, and general interest/regulator members to participate in the U.S. adoption of ISO 25539-2:2020, Cardiovascular implants—Endovascular devices—Part 2: Vascular stents; the revision of ISO 25539-3, Cardiovascular implants—Endovascular devices—Part 3: Vena cava filters. Contact: Jill Zajac
AAMI BG, Blood/Gas Exchange Device. The committee is seeking user, industry, and general interest/regulator members to participate in the development of the following Cardiovascular implants and artificial organs documents: ISO 18193, Cannulae for extracorporeal circulation; Amendment 1 to ISO 18242:2016 Centrifugal blood pumps for pulsatile pumps; and revision of ISO 7199, Blood-gas exchangers. Contact: Jill Zajac
AAMI VP-WG 01, Vascular Device-drug Combination Products. The committee is seeking user, industry, and general interest/regulator members to participate in the revision of ISO 12417-1:2015, Cardiovascular implants and extracorporeal systems—Vascular device-drug combination products—Part 1: General requirement. Contact: Jill Zajac
AAMI RD, Renal Disease and Detoxification. The committee is seeking industry, user, and general interest/regulator members to participate in the revision of the ISO 23500:2019 , Preparation and quality management of fluids for haemodialysis and related therapies series standards: Part 1: General requirements; Part 2: Water treatment equipment for haemodialysis applications and related therapies; Part 3, Water for haemodialysis and related therapies; Part 4: Concentrates for haemodialysis and related therapies; Part 5, Quality of dialysis fluids for haemodialysis and related therapies; and the revision of the ISO 8637, Extracorporeal systems for blood purification series standards: Part 1, Haemodialysers, haemodiafilters, haemofilters, and haemoconcentrators, Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters, and haemofilters; and Part 3, Plasmafilters. Contact: Jill Zajac
AAMI HIT-WG01, Health IT Risk Management Working Group. The working group is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI HIT1000-3/Ed.1, Safety and effectiveness of health IT software and systems—Part 3: Application of risk management. Contact: Chenai Maguwah
AAMI HIT-WG02, Health IT Quality Systems Working Group. The working group is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI HIT1000-2/Ed.1, Health IT software and systems—Part 2: Application of quality systems principles and practices. Contact: Chenai Maguwah
AAMI HIT-WG03, Health IT Usability Working Group. The working group is seeking industry, user, general interest, and regulatory members to participate in the development of - AAMI HIT1000-4/Ed.1, Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering. Contact: Chenai Maguwah
AAMI AI, Artificial Intelligence. The committee is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI TIR34971, Guidance on the Application of ISO 14971 to Artificial and Machine Learning. Contact: Hae Choe
AAMI SM-WG01, Software Working Group. The group is seeking user, general interest, and regulatory members to participate in the development of TIR45: Guidance on the use of AGILE practices in the development of medical device software. Contact: Ovidiu Munteanu
AAMI SM-WG03, Interoperability Working Group. The group is seeking general interest, regulatory, and users. The committee is developing a new American national standard, AAMI Safe Remote Control of Medical Devices. Contact: Ovidiu Munteanu
AAMI SM-WG05, Medical Device Security Working Group. The group is seeking general interest, regulatory, and users. The committee is developing a new American national standard, AAMI SW96, Standard for medical device security—Security risk management for device manufacturers.
Contact: Ovidiu Munteanu
AAMI SM-WG10, Cloud Computing Working Group. The group is seeking industry, user, general interest, and regulatory members to participate in the development of a TIR based on the approved AAMI CR510:2021, Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices. Contact: Ovidiu Munteanu
AAMI EV-WG05, Hospital Beds Working Group. The group is seeking industry, user, general interest, and regulatory members to participate in the development of IEC 80601-2-52 ED1: Medical electrical equipment—Part 2-52: Particular requirements for the basic safety and essential performance of medical beds, and IEC 80601-2-89 ED1: Medical electrical equipment—Part 2-89: Particular requirements for the basic safety and essential performance of medical beds for children.Contact: Ladan Bulookbashi

Upcoming Meetings

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.

September 2022

AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen

AAMI TIB-WG04, Elastomeric parts, components, and packaging (virtual meeting). 6 September 2022, 10:30h to 12:00h (CST) to discuss AAMI TIR112, Guidance for closed system transfer device (CSTD) testing with hazardous drugs. Contact Sam Alameda

AAMI PC-WG03, Pacemaker & ICD MRI Compatibility (open meeting). 8 September 2022, 10:00h to 11:30h EST, web meeting. Contact: Ladan Bulookbashi

Packaging Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 12 September 2022, 13:00h to 17:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Steam Sterilization Hospital Practices Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 12 September 2022, 13:00h to 17:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Microbiological Methods Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 12 September 2022, 13:00h to 17:00h EST, and 13 September 2022, 08:00h to 12:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

AAMI Fall 2022 Sterilization Standards Week (open meetings – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 12-15 September 2022, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: sterilization@aami.org

Endoscope Reprocessing Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 13 September 2022, 08:00h to 17:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Radiation Sterilization Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 13 September 2022, 13:00h to 17:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Industrial EO Sterilization Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 14 September 2022, 08:00h to 12:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Moist Heat Sterilization Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 14 September 2022, 13:00h to 17:00h EST, and 15 September 2022, 08:00h to 12:00h EST, Arlington, VA, and web meeting.
Contact: sterilization@aami.org

Compatibility of Materials Subject to Sterilization Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 13 September 2022, 08:00h to 17:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Water Quality for Reprocessing Medical Devices Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 14 September 2022, 08:00h to 17:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Steam Sterilization Dental Practices Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 15 September 2022, 08:00h to 12:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Chemical Sterilization Hospital Practices Working Group (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 15 September 2022, 08:00h to 12:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

Protective Barriers Committee (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 15 September 2022, 08:00h to 12:00h EST, Arlington, VA, and web meeting. Contact: sterilization@aami.org

US TAG to ISO/TC 198 (open meeting – advanced registration REQUIRED; public registration opens August 15^th through the AAMI Store). 15 September 2022, 13:00h to 15:00h EST, Arlington, VA, and web meetings. Contact: sterilization@aami.org

AAMI ID, Infusion Device Committee (open meeting). 23 September 2022, 13:00h to 15:00h EST, web meeting. Contact: Ladan Bulookbashi

October 2022

US TAG to ISO/TC 210 (AAMI Quality Management and Corresponding General Aspects for Medical Devices) (open meeting). 4 October 2022, 14:00h to 16:00h EST, web meeting.
Contact: Amanda Benedict

AAMI SP, Sphygmomanometer Committee (open meeting). Monday, 10 October, 11:00h to 12:30h EST, web meeting. Contact: Ladan Bulookbashi

AAMI PC, Cardiac Rhythm Management Device Committee (open meeting – advanced registration REQUIRED). Wednesday, 12 October, 9:00h to 17:00h EST, Arlington, VA, and web meeting.
Contact: Ladan Bulookbashi

November 2022

AAMI RD, Renal Disease and Detoxification Committee Infusion Device Committee (open meeting).
6 -7 November 2022, Details to follow, Orlando FL, hybrid meeting. Contact: Jill Zajac

March 2023

AAMI Spring 2023 Sterilization Standards Week (open meetings – 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@aami.org

September 2023

AAMI Fall 2023 Sterilization Standards Week (open meetings – 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@aami.org

International 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.

October/November 2022

IEC/TC 62, Electrical equipment in medical practice, and subcommittees 62A, 62B, 62C, and 62D (closed meeting). 24 October-4 November 2022, 8:00h to 17:00h EST, Plenary meeting, and meetings of affiliated working groups. Contact: Hae Choe

December 2022

ISO/TC 198, Sterilization of health care products and meetings of affiliated groups (closed meetings). 5-9 December 2022, 9:00h 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, 9:00h to 17:30h EST, Plenary meeting, and meetings of affiliated working groups. Contact: Amanda Benedict

Miscellaneous

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.