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Full Description

Specifies requirements for the use of moist heat in sterilization process development, validation of the sterilization process and control of routine sterilization. Covers all moist heat processes, including saturated steam and air-steam mixtures, and applies to all industrial manufacturers and all others who perform contract moist heat sterilization. Although moist heat sterilization in non-industrial health care facilities is not specifically covered, the principles outlined may be useful to the user of moist heat sterilization in these facilities.
 

Document History

  1. ISO 17665:2024


    Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

    • Most Recent
  2. ISO/TS 17665-3:2013


    Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization

    • Historical Version
  3. ISO/TS 17665-2:2009


    Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1

    • Historical Version
  4. ISO 17665-1:2006


    Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

    • Historical Version
  5. ISO 11134:1994

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    Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization

    • Historical Version