TIS 2612.1-2013 Sterilization of heal th care products-ethylene oxide 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 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements*， 2014-11-01 Update
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
ISO 14161 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
ISO 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
TIS 13485-2004 Medical devices.quality management systems.requirements for regulatory purposes
TIS 2395.1 Biological evaluation of medical devices.part 1: evaluation and testing
TIS 2395.7 Biological evaluation of medical devices.part 7: ethylene oxide sterilization residuals
TIS 2612.1-2013 history
2014TIS 2612.1-2013 Sterilization of heal th care products-ethylene oxide part 1:requirements for development,validation and routine control of a sterilization process for medical devices