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Full Description

Specifies general requirements for the characterization of a sterilizing agent, and for the development, validation and routine control of a sterilization process for medical devices. This standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means. This standard is intended to be applied by process developers manufacturers of sterilization equipment, manufacturers of products to be sterilized and the organization with responsibility for sterilizing the product.
 

Document History

  1. AAMI/ISO 14937:2009/(R)2013


    Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

    • Most Recent
  2. AAMI/ISO 14937:2000

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    Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

    • Historical Version
  3. AAMI/ISO 14937


    Sterilization of health care products- General requirements for characterization of a sterlizing agent and the development, validation, and routine control of a sterilization process for medical devices

    • Historical Version