JIS T 0806-1:2010 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 10012 Measurement management systems - Requirements for measurement processes and measuring equipment
ISO 11737-1 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1*， 2021-05-19 Update
ISO 11737-2 Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process*， 2019-12-02 Update
JIS Q 13485:2005 Medical devices -- Quality management systems -- Requirements for regulatory purposes
JIS T 0806-2:2010 Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
JIS T 0806-1:2010 history
2022JIS T 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
2015JIS T 0806-1:2015 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
2010JIS T 0806-1:2010 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices