GB/T 19974-2005 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/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/T 19022.1-1994 YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY/T 0288-1996 Quality system—Medical devices—Particular requirements for the application of GB/T 19002—ISO 9002 GB 4793.1-1995 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 1:General requirements GB 4793.1-2007 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 1:General requirements GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General GB 18281.1-2015 Sterilization of health care products—Biological indicators—Part 1:General requirements GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements GB 18282.1-2015 Sterilization of health care products—Chemical indicator—Part 1:General requirements GB/T 19973.1-2005 Sterilization of medical devices—Microbiological methods—Part 1:Estimation of population of microorganisms on products GB/T 19973.1-2015 Sterilization of medical devices—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 19973.1-2023 Sterilization of health care products—Microbiological methods—Part 1:Determination of a population of microorganisms on products GB/T 19973.2-2005 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the validation of a sterilization process GB/T 19973.2-2018 Sterilization of medical devices—Microbiological methods—Part 2:Tests of sterility performed in the definition,validation and maintenance of a sterilization process GB/T 18281.1-2024 Sterilization of health care products—Biological indicators—Part 1:General requirements GB/T 18282.1-2025 Sterilization of health care products—Chemical indicators—Part 1:General requirements GB/T 19973.2-2025 Sterilization of health care products—Microbiological methods—Part 2:Tests of sterility performed in the definition, validation and maintenance of a sterilization process GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents

ISO 14937:2000