GB 16174.1-2024 Implants for surgery—Active implantable medical devices—Part 1:General requirements for safety,marking and for information to be provided by the manufacturer

GB 16174.2-2024 Implants for surgery—Active implantable medical devices—Part 2:Cardiac pacemakers

GB 16174.1-2015 Implants for surgery—Active implantable medical devices—Part 1:General requirements for safety,marking and for information to be provided by the manufacturer

GB/T 2423.5-2019 Environmental testing—Part 2:Test methods—Test Ea and guidance:Shock GB/T 2423.22-2012 Environmental testing—Part 2:Test methods—Test N:Change of temperature GB/T 2423.43-2008 Environmental testing for electric and electronic products—Part 2:Test methods—Mounting of specimens for vibration, impact and similar dynamic tests GB/T 2423.56-2023 Environmental testing—Part 2:Test methods—Test Fh:Vibration,broadband random and guidance GB/T 7408.1-2023 Date and time—Representations for information interchange—Part 1:Basic rules GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 42062-2022 Medical devices—Application of risk management to medical devices YY/T 0664-2020 Medical device software—Software life cycle processes ISO 14155 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 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

ISO 14708-1:2014