GB/T 12279.1-2024 Cardiovascular implants—Cardiac valve prostheses—Part 1:General requirements

GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes

GB 12279-2008 Cardiovasular implants—Cardiac valve prostheses

GB/T 12279.2-2024 Cardiovascular implants—Cardiac valve prostheses—Part 2:Surgically implanted heart valve substitutes YY/T 0640-2016 Non-active surgical implants—General requirements ISO 5840-3 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 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for 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 GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation 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 18280.2-2015 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB/T 18280.3-2015 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects GB/T 19633-2005 Packaging for terminally sterilized medical devices GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems GB/T 19633.2-2015 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes GB/T 19633.2-2024 Packaging for terminally sterilized medical devices—Part 2:Validation requirements for forming,sealing and assembly processes 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 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes GB/T 42062-2022 Medical devices—Application of risk management to medical devices YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling YY/T 0771.4-2015 Medical devices utilizing animal tissues and their derivatives—Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes YY 0970-2013 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid sterilants 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/T 1474-2016 Medical devices—Application of usability engineering to medical devices YY/T 1600-2018 Product family and processing category for steam sterilization of medical devices YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors GB/T 18280.2-2025 Sterilization of health care products—Radiation—Part 2:Establishing the sterilization dose GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices GB/T 18280.3-2025 Sterilization of health care products—Radiation—Part 3:Guidance on dosimetric aspects of development,validation and routine control

ISO 5840-1:2021