T/CSBME 074-2023 Artificial Cochlea Calibration System

GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment GB 16174.1-1996 Cardiac pacemakers—Part 1:Implantable 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 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/T 25000.51-2010 Software engineering—Software product Quality Requirements and Evaluation (SQuaRE)—Requirements for quality of Commercial Off-The-Self (COTS) software product and instructions for testing GB/T 25000.51-2016 Systems and software engineering—Systems and software Quality Requirements and Evaluation (SQuaRE)—Part 51:Requirements for quality of Ready to Use Software Product(RUSP) and instructions for testing YY 0989.7-2017 Implants for surgery—Active implantable medical devices—Part 7:Particular requirements for cochlear implant systems YY/T 1843-2022 Basic requirements of cybersecurity for medical electrical equipment YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests