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About This Item

 

Full Description

This document provides requirements for the development, validation and routine control of moist heat sterilization processes for medical devices. It also contains guidance which is intended to explain the requirements set forth in the normative sections. The guidance given is intended to promote good practice related to moist heat sterilization processes according to this document. The application within industrial and health care settings is considered.
 

Document History

  1. ISO 17665:2024

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    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


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

    • Historical Version