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ISO/FDIS 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
prEN ISO 11135
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2024)
ISO/CD 19253
Sterilization of health care products - Moist heat - Requirements for sterilizers used for the terminal sterilization of aqueous liquid in sealed containers”.
EN 285/FprA1
Sterilization - Steam sterilizers - Large sterilizers
prEN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
DIN EN ISO 11135
Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024
DIN EN ISO 17665
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024); German version EN ISO 17665:2024
ISO/DIS 10993-7
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
EN ISO 10993-7/prA11
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
DIN EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2023); German and English version FprEN ISO 11137-1:2023
