ISO 17665

What is ISO 17665?

ISO 17665 is the international standard for developing, validating and routinely controlling moist heat sterilization processes for medical devices. Its purpose is to ensure that a process used to turn non-sterile product into sterile product is defined, validated, monitored and kept under control.

The current edition is ISO 17665:2024. It replaced ISO 17665-1:2006, ISO/TS 17665-2:2009 and ISO/TS 17665-3:2013, bringing the previous requirements and supporting guidance into one publication. Technical files and supplier agreements should therefore be checked for references that still identify the withdrawn 2006 edition as current.

Which sterilization processes does ISO 17665 cover?

The standard applies to moist heat processes used for medical devices. Saturated steam is a common application, but the scope is defined around moist heat sterilization rather than one particular sterilizer model or cycle name.

Applicability depends on the product, packaging, load configuration and process. The manufacturer must also establish that the selected method is suitable for the device and does not unacceptably affect its materials, performance, packaging or safety.

What must be validated under ISO 17665?

Validation demonstrates that the defined process can consistently deliver the intended sterilization outcome for the specified product and load. It includes defining the product and process, qualifying the equipment, establishing process parameters and acceptance criteria, and documenting evidence that the process performs reproducibly.

Routine control then confirms that validated conditions continue to be achieved. Changes involving equipment, cycle parameters, product design, packaging, load pattern or processing site should be evaluated through change control and may require additional qualification or revalidation.

ISO 17665 does not replace the manufacturer’s wider risk management, packaging, biocompatibility, shelf-life and quality-system responsibilities.

How is ISO 17665 different from ISO 11135 and ISO 11137?

The standards address different sterilization technologies. ISO 17665 covers moist heat, ISO 11135 covers ethylene oxide, and ISO 11137 covers radiation. A manufacturer should use the standard applicable to the selected method rather than treating the three as interchangeable validation routes.

The resulting evidence becomes part of the device’s technical documentation and market submission where applicable. See our global market access services, EU MDR consulting overview and United States market guide for the wider regulatory context.