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Requirements for development, validation and routine control of sterilization process for sterilized medical devices

Requirements for development, validation and routine control of sterilization process for sterilized medical devices, Total:18 items.

In the international standard classification, Requirements for development, validation and routine control of sterilization process for sterilized medical devices involves: Sterilization and disinfection.

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
• GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
• GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
• GB/T 19974-2018 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
• GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

European Committee for Standardization (CEN), Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
• EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
• EN ISO 25424:2019/prA1:2021 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/DAM 1:2021)
• EN ISO 25424:2019/A1:2022 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1 (ISO 25424:2018/Amd 1:2022)

Professional Standard - Medicine, Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• YY/T 1464-2016 Sterilization of medical devices.Requirements for the development, validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices
• YY/T 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices
• YY 1276-2016 Requirements for development, validation and routine control of dry heat sterilization process for medical devices

国家药监局, Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products
• YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes

UNKNOWN, Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• GB/T 18279.1-2015 Ethylene oxide for sterilization of healthcare products Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices

German Institute for Standardization, Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• DIN EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009); German version EN ISO 25424:2011

Association Francaise de Normalisation, Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• NF S98-104*NF EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

International Organization for Standardization (ISO), Requirements for development, validation and routine control of sterilization process for sterilized medical devices

• ISO/DIS 17665 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

Others:   Requirements for development, validation and routine control of sterilization process for sterilized medical devices, Requirements for development, validation and routine control of dry heat sterilization process for medical devices.