Agenda
     •  Role of Standards
     •  AAMI Overview
     •  ASTM Overview
     •  Standards Alignment
     •  Other Forums – Call to Action        Continuing the Conversation
  September 17, 2020          John A. Williams, Medtronic           2
       Role of Standards
    Why does my organization use standards?
    Compliance with voluntary consensus standards enhances our ability to bring products to 
    the global marketplace by: 
    • Making regulatory submissions more uniform, faster and more cost effective. 
    • Reducing regulatory submission review and approval times. 
    • Reducing the regulatory need for more than one product design worldwide. 
    • Assisting in the production of products with the greatest possible reliability and quality. 
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       AAMI Overview
    The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit 
    organization founded in 1967. It is a diverse community of more than 9,000 professionals 
    united by one important mission—the development, management, and use of safe and 
    effective health technology. AAMI is the primary source of consensus standards, both 
    national and international, for the medical device industry, as well as practical 
    information, support, and guidance for healthcare technology and sterilization 
    professionals.
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                    AAMI Overview
       ST - Sterilization Standards Committee (U.S. TAG to ISO/TC 198)
       Description
       The AAMI ST - Sterilization Standards Committee provides input into international standards by acting as the mirror 
       committee and U.S. TAG to ISO/TC 198 - sterilization of healthcare products which develops standards on the processes and 
       equipment for sterilization of health care products. (32 Working Groups)
              ST/WG 01 - Industrial EO sterilization Working Group                                   ST/WG 13 - Washer Disinfectors Working Group                                         ST/WG 85 - Human Factors for Device Reprocessing Working Group
              ST/WG 02 - Radiation Sterilization Working Group                                       ST/WG 15 - Sterility Assurance Level (SAL) Working Group                             ST/WG 86 - Quality Systems for Device Reprocessing Working Group
              ST/WG 03 - Industrial Moist Heat Sterilization Working Group                           ST/WG 40 - Steam Sterilization Hospital Practices Working Group                      ST/WG 91 - Resistometer Working Group
              ST/WG 04 - Biological Indicators Working Group                                         ST/WG 42 - Dry Heat Sterilization Working Group                                      ST/WG 92 - Process Challenge Devices Working Group
              ST/WG 05 - Sterilization Terminology Working Group                                     ST/WG 43 - Hospital Steam Sterilizer Working Group                                   ST/WG 93 - Cleaning of Reusable Medical Devices Working Group
              ST/WG 06 - Chemical Indicators Working Group                                           ST/WG 60 - EO Sterilization Hospital Practices Working Group                         ST/WG 94 - Rigid Sterilization Container Systems Working Group
              ST/WG 07 - Packaging Working Group                                                     ST/WG 61 - Chemical Sterilants Hospital Practices Working Group                      ST/WG 95 - Water Quality for Reprocessing Medical Devices Working Group
              ST/WG 08 - Microbiological Methods Working Group                                       ST/WG 62 - Hospital Ethylene Oxide Sterilizer Working Group                          ST/WG 96 - Compatibility of Materials Subject to Sterilization Working Group
              ST/WG 09 - Aseptic Processing Working Group                                            ST/WG 63 - Sterilization Residuals Working Group                                     ST/WG 11 - General Criteria for Sterilization Processes and Sterilizing Equipment Working
                                                                                                                                                                                              Group
              ST/WG 10 - Liquid Chemical Sterilization Working Group                                 ST/WG 83 - Reusable Surgical Textiles Processing Working Group
                                                                                                                                                                                            ST/WG 16 - Vaporized Hydrogen Peroxide Sterilization
              ST/WG 12 - Instructions for Reusable Device Reprocessing Working Group                 ST/WG 84 - Endoscope Reprocessing Working Group
       September 17, 2020                                                                                               John A. Williams, Medtronic                                                                                                                               5
       AAMI Overview
     ST/WG02 – Radiation Sterilization Working Group
     • Scope
        • Is focused on requirements for establishing, validating, implementing and monitoring radiation 
         processes used to sterilize health care products with gamma, electron beam or x-ray
        • Is the US TAG to ISO/TC 198 Sterilization of health care products, providing US input to development 
         of ISO standards and technical specifications on Radiation Sterilization
        • Authors Technical Information Reports (TIRs) to provide guidance on aspects of radiation sterilization
     • Membership
        • 65 member companies, more that 100 active individuals
        • ~50% medical device manufacturers
        • ~25% consultants
        • ~20% service and equipment providers
        • ~5% regulatory
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