YY 0989.7-2017 Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems

ISO 14155 IEC 60118-6 IEC 60601-1 EN 1593 EN 13185 GB/T 2423.5-1995 Environmental testing for electric and electronic products—Part 2:Test methods—Test Ea and guidance:Shock GB/T 2423.5-2019 Environmental testing—Part 2:Test methods—Test Ea and guidance:Shock GB/T 2423.7-1995 Environmental testing for electric and electronic products Part 2:Test Ec and quidance:Drop and topple (Primarily for equipment-type specimens) GB/T 2423.7-2018 Environmental testing—Part 2:Test methods—Test Ec:Rough handling shocks,primarily for equipment-type specimens GB/T 2423.43-1995 Environmental testing for electric and electronic products Part 2:test methods—Mounting of components, equipment and other articles for dynamic tests including shock(Ea), bump(Eb), vibration(Fc and Fd) and steady-state acceleration(Ca) and guidance 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 2423.56-2006 Environmental testing for electric and electronic products—Part 2:Test methods—Test Fh:Vibration, broad-band random(digital control)and guidance GB/T 2423.56-2018 Environmental testing—Part 2:Test methods—Test Fh:Vibration, broadband random and guidance GB/T 2423.56-2023 Environmental testing—Part 2:Test methods—Test Fh:Vibration,broadband random and guidance GB/T 2423.55-2006 Environmental testing for electric and electronic products—Part 2:Test methods—Test Eh:Hammer tests GB/T 2423.55-2023 Environmental testing—Part 2:Test methods—Test Eh:Hammer tests 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 17626.2-1998 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.2-2006 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test GB/T 17626.2-2018 Electromagnetic compatibility—Testing and measurement techniques—Electrostatic discharge immunity test 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 YY/T 0316-2003 Medical devices—Application of risk management to medical devices YY/T 0316-2008 Medical devices—Application of risk management to medical devices YY/T 0316-2016 Medical devices—Application of risk management to medical devices YY 0505-2005 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY 0505-2012 Medical electrical equipment—Part 1-2:General requirements for safety—Collateral standard:Electromagnetic compatibility—Requirements and tests YY/T 0664-2008 Medical device software—Software life cycle processes YY/T 0664-2020 Medical device software—Software life cycle processes YY/T 0316-2000 YY/T 0316-2000 Medical devices - Risk analysis - Part 1: Application of risk analysis

ISO 14708-7:2013