YY 0970-2023 Sterilization of health care products—Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives—Requirements for characterization,development,validation and routine control of a sterilization process for medical device

YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid sterilants

中华人民共和国药典　第四部通则　1101无菌检验法 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/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 YY/T 0567.1-2005 Aseptic processing of health care products—Part 1:General requirements YY/T 0567.1-2013 Aseptic processing of health care products—Part 1:General requirements YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration YY/T 0567.2-2021 Aseptic processing of health care products—Part 2:Sterilizing filtration YY/T 0567.3-2011 Aseptic processing of health care products—Part 3:Lyophilization YY/T 0567.4-2011 Aseptic processing of health care products—Part 4:Clean-in-place technologies YY/T 0567.5-2011 Aseptic processing of health care products—Part 5:Sterilization in place YY/T 0567.6-2011 Aseptic processing of health care products—Part 6:Isolator systems YY/T 0567.6-2022 Aseptic processing of health care products—Part 6:Isolator systems YY/T 0567.7-2016 Aseptic processing of health care products—Part 7:Alternative processes for medical devices and combination products GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents

ISO 14160:2020