International Standard
ISO 17665:2024
Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices
Reference number
ISO 17665:2024
Edition 1
International Standard
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ISO 17665:2024
Published (Edition 1, 2024)

ISO 17665:2024

ISO 17665:2024
CHF 216
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What is ISO 17665? 

ISO 17665 outlines requirements for moist heat sterilization processes, ensuring the transformation of non-sterile medical devices into sterile ones. It addresses the inactivation of microbiological contaminants, emphasizing the need for validated, controlled, and monitored sterilization processes.

Why is ISO 17665 important? 

This standard is crucial for ensuring the sterility of medical devices, a fundamental requirement in healthcare to prevent infections. It guides manufacturers in effective sterilization techniques, contributing to patient safety and product reliability.


  • Enhances the safety and sterility of medical devices
  • Provides a comprehensive framework for sterilization processes
  • Supports compliance with regulatory and quality standards
  • Promotes consistency and reliability in medical device sterilization


Manufacturers and sterilization facilities for medical devices.

It is specifically tailored to those requiring moist heat sterilization.

General information

  •  : Published
     : 2024-03
    : International Standard published [60.60]
  •  : 1
     : 154
  • ISO/TC 198
  • RSS updates

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