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.

Why it matters

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

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.

Sources

ISO 17665 · ISO
FDA Recognized Consensus Standards · FDA
ISO Standards Catalogue - Health · ISO

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