ISO 17665 is officially titled:
“Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices”
It is divided into multiple parts:
This standard provides a framework for designing, validating, and routinely controlling moist heat sterilization processes, particularly in hospital sterilization units, medical device manufacturing, and contract sterilization services.
Sterilization failures can lead to severe patient harm, regulatory penalties, or product recalls. Moist heat (typically involving saturated steam under pressure) is one of the most effective and widely used sterilization methods, but it must be validated for efficacy, repeatability, and safety.
ISO 17665 is the global reference for ensuring sterilization cycles:
Adopting ISO 17665 brings several technical and operational benefits:
Here's how ISO 17665 supports your business:
Meet standards set by ISO, WHO, FDA, EU MDR, and other healthcare regulators.
Reduce batch failures, reprocessing, and downtime by standardizing procedures.
Demonstrate a commitment to patient and user safety through validated sterilization.
Streamline ISO 13485, ISO 9001, and GMP compliance with aligned sterilization processes.
Required documentation for CE marking, FDA 510(k), and other regulatory pathways.
Traceable, documented sterilization processes reduce legal and clinical risks.
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