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    ISO 17665

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

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 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. Moist heat (steam) sterilization is widely used for reusable instruments and heat-tolerant products. The standard covers characterizing the sterilizing agent, process and equipment definition, product definition, validation (installation, operational and performance qualification) and routine monitoring and control. For reusable devices, manufacturers must also validate reprocessing instructions, which are covered by ISO 17664.
    What the regulation says
    ISO 17665 is recognized by regulatory bodies worldwide as a key standard for moist-heat sterilization, particularly for medical devices, as noted by the FDA in its guidance on reprocessing medical devices. Compliance with this standard helps manufacturers and healthcare facilities demonstrate that their sterilization processes are effective and consistently achieve sterility, which is essential for meeting the safety requirements of regulations like the EU MDR, Annex I, Section 17.2.

    What this means in practice

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

    Examples

    • A MedTech manufacturer developing a new reusable surgical instrument must validate its moist-heat sterilization instructions according to ISO 17665 before placing the device on the market.
    • A hospital central sterile supply department (CSSD) uses ISO 17665 as a framework to ensure that its steam sterilizers are correctly operated and routinely monitored for effective sterilization of surgical trays.
    • An auditor reviewing a medical device manufacturer's quality management system would expect to see documented evidence of sterilization process validation in line with ISO 17665, including reports on physical, chemical, and biological indicators.
    Common pitfalls
    • •A common pitfall is failing to re-validate sterilization processes after changes to device design, packaging materials, or sterilization equipment.
    • •Another mistake is neglecting to establish clear process parameters and acceptance criteria for routine monitoring, leading to inconsistencies in sterilization outcomes.
    • •Many organizations incorrectly assume that simply purchasing ISO 17665 compliant equipment guarantees a validated process, overlooking the need for site-specific validation studies.
    • •Inadequate documentation of validation activities and routine monitoring records often results in non-compliance during regulatory audits.
    • •Failing to define and implement appropriate corrective actions when sterilization process deviations occur is a significant oversight.

    Frequently asked questions

    The primary purpose is to specify requirements for the development, validation, and routine control of sterilization processes for medical devices using moist heat, ensuring the sterility and safety of reprocessed items.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    ISO·2FDA·1
    1. 1
      ISO 17665
      Tier 1 Verified
      ISOiso.org
    2. 2
      FDA Recognized Consensus Standards
      Tier 2 Verified
      FDAaccessdata.fda.gov
    3. 3
      ISO Standards Catalogue - Health
      Tier 1 Verified
      ISOiso.org

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