Applicable ISO Standards for Sterilization
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Please refer to the following standards applicable for sterilization:
1. ISO 11135:2014-Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, ,validation and routine control of a sterilization process for medical devices
2. ISO 11137-1:2006-Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
3. ISO 17665-1:2006: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
4. ISO 20857:2010-Sterilization of health care products -- Dry heat -- Requireme nts for the development, validation and routine control of a sterilization process for medical devices
5. ISO 25424:2018-Sterilization of health care products -- Low temperature steam and formaldehyde -- Requirements for development, validation and routine control of a sterilization process for medical devices
You may refer further to the link: https://www.iso.org/committee/54576/x/catalogue/p/1/u/0/w/0/d/0 which will provide detailed description of each standard.
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Nov 29, 2018