AAMI Standards Monitor Digest: February 2020

Categories: AAMI News, Government, HTM Professionals, Medical Device Manufacturers, Medical Device Manufacturing, Sterilization Professionals

Newly Published

  • ANSI/AAMI/ISO 11138-7:2019, Sterilization of health care products—Biological indicators—Part 7: Guidance for the selection, use, and interpretation of results More info
  • AAMI TIR97:2019, Principles for medical device security—Postmarket risk management for device manufacturers More Info
  • AAMI CR500:2019, Basic Introduction to the IEC 60601 Series More info
  • ANSI/AAMI/ISO 14971:2019, Medical devices—Application of risk management to medical devices More info

Calls for Participation

  • AAMI/CN, Small Bore Connectors Committee
    The committee is seeking user, regulatory, and general interest members to participate in development of AAMI/ISO 80369-7, Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications.
    Contact: Colleen Elliott at celliott@aami.org
  • 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: Patrick Bernat at pbernat@aami.org

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