• AAMI Foundation
    • AAMI Foundation
  • About AAMI
    • About AAMI
    • Leadership
    • AAMI Center for Excellence
    • Strategic Plan
    • Work at AAMI
    • Directions to AAMI
    • Press Room
    • AAMI Foundation
  • Join/Renew
    • Join/Renew
  • Visit ARRAY
    • Visit ARRAY
    • What is ARRAY?
    • AAMI News
    • BI&T
    • Press Room
    • Advertise with AAMI
  • Engage
    • Engage
    • AAMI Connect
    • Committee Central
  • Store
    • Store
    • Catalog
    • AAMI eSubscription
    • AAMI Products
  • Account
    • My Account
    • Logout
  • Login
AAMI-logo
  • Focus Areas
    HTM
    • HTM Overview
    • HTM Resources
      Resources Overview HTM in a Box HTM Academic Programs HTM Webinars HTM Associations
    • Cybersecurity Resources for HTM
    • Training and Certification
    • BMET Apprenticeship
    • HTM Week
    • #IamHTM
    • Search for Jobs
    Sterilization
    • Sterilization Overview
    • ANSI/AAMI ST79
    • ANSI/AAMI ST91
    • Training and Certification
    • Search for Jobs
    Medical Devices and Technology
    • Medical Devices and Technology Overview
    • Top Resources
    • Participate in Standards
    • Training
    Cybersecurity
    • Cybersecurity Overview
    • Top Resources
    • Participate in Standards
    • Training
    • Search for Jobs
  • Standards
    • Standards
    • Committee Central Resources
    • ANSI/AAMI ST79
    • ANSI/AAMI ST91 2021
    • International Standards Conference 2022
    • How are Standards Developed
    • Participate in Standards Development
    • View Full Committee List
    • Search For a Committee
    • Standards Monitor Online
    • Standards Insider Webinar Series
    • COVID-19 Resources
    • ANSI/AAMI PB70:2022
  • Events
    • AAMI eXchange23
    • View All Events
    • AAMI Center for Excellence
    • Hotels Near AAMI
  • Training & Certification
    • Training & Certification
    • About ACI
      ACI Home Maintain Your Certification Certification Directory ACI FAQs and Resources
    • Courses by Topic
      Quality Systems Human Factors Sterilization Software/Cybersecurity Healthcare Technology Management (HTM) Regulatory Expert Insights from AAMI Training
    • Private Training
    • Access My Learning
  • Membership
    • Membership
    • Individual Membership
    • Institutional Membership
    • Corporate Membership
    • Awards
      Awards Bright Ideas Michael J Miller Scholarship Program
    • Mentorship Program
    • AAMI Fellow Program
    • Career Center
    • AAMI Town Halls

    AAMI Standards Monitor Online 5 April 2021

    Standards Monitor Online

    • Recently Published
    • Call for Comments
    • New Work
    • Consensus
    • Upcoming Meetings
    • Issues
     

    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:

     

    Download PDF

     

     

     

    Recently Published

     
    • NEW! ANSI/AAMI/ISO 10993-16:2017

      Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables. Purchase here.

    • REAFFIRMED! AAMI TIR74, Change Summary For ISO 11135:2014

      Sterilization Of Health Care Products - Ethylene Oxide - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices was reaffirmed February 11, 2021.

     

    AAMI Call for Comments

     

    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.

    Comments due April 26, 2021

    AAMI/ISO 11140-3, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (reaffirmation of an American National Standard). This standard specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g., instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1. Contact: Amanda Benedict

    AAMI/ISO 11140-4, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration (reaffirmation of an American National Standard). This standard specifies performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (e.g., instruments and porous loads). Contact: Amanda Benedict

    AAMI/ISO 11140-5, Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests (reaffirmation of an American National Standard). This standard specifies the requirements for an indicator and alternative test system used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.. Contact: Amanda Benedict

    AAMI ST15883-2, Washer-disinfectors — Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc (reaffirmation of an American National Standard). This standard specifies particular requirements for washer disinfectors (WD) that are intended for use for the cleaning and thermal disinfection, in a single operating cycle, of re-usable medical devices such as surgical instruments, anesthetic equipment, bowls, dishes and receivers, utensils and glassware. Contact: Amanda Benedict

    AAMI ST15883-3, Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (reaffirmation of an American National Standard). This standard specifies particular requirements for washer-disinfectors (WD) that are intended to be used for emptying, flushing, cleaning and thermal disinfection of containers used to hold human waste for disposal by one operating cycle. Contact: Amanda Benedict

    AAMI/ISO 17664-2, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices (expedited national adoption of an international standard). This standard specifies requirements for the information to be provided by the medical device manufacturer for the processing of medical devices not intended for direct patient contact. This includes information for processing prior to use or reuse of the medical device. Contact: Amanda Benedict

    AAMI/ISO 20857, Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices (reaffirmation of an American National Standard). This standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat. Contact: Amanda Benedict

    Comments due May 17, 2021

    AAMI ST15883-1, Washer-disinfectors, Part 1: General requirements, terms and definitions and tests & A1 & A2 (reaffirmation of an American National Standard and amendments). This standard specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified. Contact: Amanda Benedict

    AAMI SW96, Standard for medical device security — Security risk management for device manufacturers (proposed new American National Standard). This standard provides requirements and guidance when addressing design, production and post-production security risk management within the risk management framework defined by ANSI/AAMI/ISO 14971. While it is based on the ANSI/AAMI/ISO 14971 framework for medical device risk management, most concepts are applicable to any healthcare product, including digital health, that requires the management of security. Contact: Ovidiu Munteanu

     

    New Work

     

    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: Ovidiu Munteanu.

    AAMI QM-WG01, Application of Quality Systems to Medical Devices Working Group. The working group is working on the development of AAMI CR510, Consensus Report on Compliant Use of Cloud Computing for Quality Systems and Medical Devices. This Consensus Report will provide guidance to multiple stakeholders regarding the appropriate and compliant use of cloud computing both as a component of medical devices and in support of quality systems. Contact: Joe Lewelling.

    AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use. The committee has recently approved development of an AAMI Technical Information Report (TIR), 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 Close 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. Contact: Jeff Linder.

    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.

    GettyImages-1148381484
     

    Please contact the staff person indicated for more information on how to join.

    • AAMI EQ, Medical Equipment Management Committee. 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: Amanda Benedict.
    • 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: Amanda Benedict.
    • AAMI ST-WG12, Instructions for reusable device reprocessing. The working group is seeking user, regulatory and general interest members to participate in the national adoptions of the ISO 17664 series. Contact: Amanda Benedict.
    • 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: Amanda Benedict.
    • AAMI ST-WG42, Dry heat sterilization. The working group is seeking user, regulatory and general interest members to participation in the reaffirmation of AAMI/ISO 20857, Sterilization of health care products — Dry heat — Requirements for the development, validation and routine control of a sterilization process for medical devices. Contact: Amanda Benedict.
    • AAMI ST-WG43, Hospital steam sterilizers. The working group is seeking user, regulatory and general interest members to participate in the reaffirmation of AAMI ST55, Table-top steam sterilizers and the revision of AAMI ST8, Hospital steam sterilizers. Contact: Amanda Benedict.
    • AAMI ST-WG84, Endoscope reprocessing. The working group is seeking regulatory and general interest members to participate in the development of AAMI ST91/Ed.2, Flexible and semi-rigid endoscope processing in health care facilities and AAMI TIR99/Ed.1, Dilators, transesophageal and ultrasound probes processing in health care facilities. Contact: Amanda Benedict.
    • AAMI ST-WG 91, Resistometers. The working group is seeking user, industry, and regulatory/general interest stakeholders to participate in the US adoption of ISO 18472:2018, Sterilization of health care equipment – Biological and chemical indicators – Test equipment. Contact: Cliff Bernier.
    • 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 US 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: Jeff Linder.
    • AAMI/CV, Cardiac valves. The committee is seeking user, industry, and general interest/regulator members to participate in the US 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: Cliff Bernier.
    • AAMI/VP, Vascular Prostheses. The committee is seeking user, industry, and general interest/regulator members to participate in the US adoption of ISO 25539-2:2020, Cardiovascular implants — Endovascular devices — Part 2: Vascular stetnts; the revision of ISO 25539-3, Cardiovascular implants — Endovascular devices — Part 3: Vena cava filters; and the development of ISO 25539-4, Cardiovascular implants — Endovascular devices — Part 4: Application of ISO 17327-1 for coated endovascular devices. Contact: Cliff Bernier
    • AAMI/BG, Blood/Gas Exchange Device Committee. 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: Cliff Bernier
    • 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 requirements and the revision of ISO/TR 12417-2:2017, Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information. Contact: Cliff Bernier
    • AAMI/VI, Cardiovascular absorbable implants. The committee is seeking user, industry, and general interest/regulator members to participate in the revision of ISO/TS 17137:2019, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants. Contact: Cliff Bernier
    • AAMI/CO, Cardiac Occluders. The committee is seeking user, industry, and general interest/regulator members to participate in the development of ISO 22679, Cardiovascular implants — Transcatheter cardiac occluders. Contact: Cliff Bernier
    • AAMI/RD, Renal Disease and Detoxification Committee. 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: Cliff Bernier
    • 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., Health IT software and systems — Part 2: Application of quality systems principles and practices. Contact: Emily Hoefer
    • AAMI AI, Artificial Intelligence Committee. The committee is seeking industry, user, general interest, and regulatory members to participate in the development of AAMI TIR 34971, Guidance on the Application of ISO 14971 to Artificial and Machine Learning. Contact: Emily Hoefer
    • AAMI/SM-WG05, Medical Device Security Working Group – seeking general interest, reg/govt 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
     

    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.

    April 2021

    Artificial Intelligence Committee (open web meeting) 2 April 2021, 10:30h to 12:30h ET. Virtual meeting. Contact: Emily Hoefer

    Luer activated valves working group (open web meeting) 16 April 2021, 10:00h to 16:00h ET. Virtual meeting. Contact: Colleen Elliott

    AAMI/CP, Combination products (open meeting), 22 April 2021, 13:00 to 17:00 h ET, Teams meeting. Contact: Cliff Bernier

    Steam Sterilization Hospital Practices Working Group (open web meting). 28 April 2021, 09:00h to 17:00h ET. Virtual meeting.  Contact: Amanda Benedict

    May 2021

    Endoscope Reprocessing Working Group (open web meeting). 4/6/12 May 2021, 11:00h to 14:00h ET. Contact: Emily Hoefer

    Cardiac Rhythm Management Devices Committee (open web meeting). 6 May 2021, 11:00h to 13:30h ET. Contact: Standards Department

    Renal Disease and Detoxification Committee (open web meeting). 7 May 2021, 11:00h to 17:00h ET. Contact: Cliff Bernier

    September 2021

    AAMI Sterilization Standards meetings (open meetings). 13-17 September 2021, 08:00h to 17:00h ET. Schedule of meetings TBD. AAMI, Arlington, VA.  Contact: Amanda Benedict

     

    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.

    April 2021

    ISO/TC 150/SC 2/WG 8, Cardiac occluders (closed meeting). 5 to 7 April 2021, Zoom meeting. Contact: Cliff Bernier

    ISO/TC 198/WG 16, Vaporized hydrogen peroxide sterilization (closed meeting), 8, 13, 15, 20 April 2021, 08:00 h to 11:00 h ET, Zoom meeting. Contact: Amanda Benedict

    IEC/TC 62 and subcommittees, Electrical equipment in medical practice (closed meeting), 12 to 23 April 2021, Zoom meeting. Contact: Hae Choe

    ISO/TC 198/WG 9, Aseptic processing (closed meeting), 29 April 2021, 12:00 h to 16:00 h CEST, Zoom meeting. Contact: Amanda Benedict

    June 2021

    ISO/TC 198/WG 1, Industrial EO sterilization (closed meeting), 29 June 2021, 13:00 h to 15:00 h IST, Zoom meeting. Contact: Amanda Benedict

     

    July 2021

    ISO/TC 121, Anaesthetic and respiratory equipment (closed meeting), 16 July 2021, Zoom meeting. Contact: Colleen Elliott.

     

    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.

     

    Issues

    12 March, 2021

    20 February 2021

    January 29, 2021

    January 8, 2021

    December 4, 2020

    November 13, 2020

    October 23, 2020

    October 2, 2020

    September 11, 2020

    August 21, 2020

    July 31, 2020

    July 10, 2020

    May 22, 2020

    May 1, 2020

    April 10, 2020

    March 20, 2020

    February 28, 2020

     

    AAMI | Advancing Safety in Health Technology
    901 N. Glebe Road, Suite 300
    Arlington, VA 22203

    T +1 703-525-4890
    F +1 703-783-0705
    Facebook Twitter Instagram LinkedIn YouTube
    • Site Map
    • Contact Us
    • AAMI Foundation
    • Advertise
    • AAMI Policies
    • Intellectual Property
    • Careers at AAMI
    © 2023 Association for the Advancement of Medical Instrumentation. All Rights Reserved.