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    ISO 17665

    Standard for moist heat (steam) sterilization of medical devices.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    ISO 17665 specifies the requirements for development, validation, and routine control of a moist-heat sterilization process. The 2024 revision consolidated industrial and healthcare-facility requirements.

    What this means in practice

    Steam sterilization is the workhorse of reusable surgical instruments and is referenced in reprocessing instructions for many devices.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISO·2FDA·1
    1. 1
      ISO 17665
      Verified
      ISOiso.org
    2. 2
      FDA Recognized Consensus Standards
      Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Verified
      ISOiso.org

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