GB 9706.255-2022 Medical electrical equipment—Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors

GB 9706.204-2022 Medical electrical equipment—Part 2-4:Particular requirements for the basic safety and essential performance of cardiac defibrillators GB 9706.222-2022 Medical electrical equipment—Part 2-22:Particular requirements for basic safety and essential performance of surgical,cosmetic,therapeutic and diagnostic laser equipment GB 9706.271-2022 Medical electrical equipment—Part 2-71:Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy(NIRS) equipment GB 9706.275-2022 Medical electrical equipment—Part 2-75:Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment GB 9706.283-2022 Medical electrical equipment—Part 2-83:Particular requirements for the basic safety and essential performance of home light therapy equipment GB 9706.290-2022 Medical electrical equipment—Part 2-90:Particular requirements for basic safety and essential performance of respiratory high flow therapy equipment

GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.14-2003 Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics GB/T 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.16-2003 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2013 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18:Chemical characterization of medical device materials within a risk management process GB/T 16886.19-2011 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation GB 16895.21-2004 Electrical installations of buildings—Part 4-41:Protection for safety-Protection against electric shock GB/T 16895.21-2011 Low-voltage electrical installations—Part 4-41:Protection for safety—Protection against electric shock GB/T 16895.21-2020 Low-voltage electrical installations—Part 4-41:Protection for safety—Protection against electric shock GB/T 16935.1-2008 Insulation coordination for equipment within low-voltage systems—Part 1:Principles,requirements and tests GB 17465.1-1998 Appliance couplers for household and similar general purposes Part 1:General requirements GB/T 17465.1-2009 Appliances couplers for household and similar general purposes—Part 1:General requirements GB/T 17465.1-2022 Appliance couplers for household and similar general purposes—Part 1:General requirements 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 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices GB 19212.2-2006 Safety of power transformers, power supply units and similar—Part 2:Particular requirements for separating transformers for general use GB/T 19212.2-2012 Safety of power transformers, power supplies, reactors and similar products—Part 2:Particular requirements and tests for separating transformers and power supplies incorporating separating transformers for general applications GB/T 19212.2-2025 Safety of transformers, reactors, power supply units and combinations thereof—Part 2:Particular requirements and tests for separating transformers and power supply units incorporating separating transformers for general applications GB/T 23821-2009 Safety of machinery—Safety distances to prevent hazard zones being reached by upper and lower limbs GB 27701-2011 Mechanical safety of cathode ray tubes GB/T 28164-2011 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells,and for batteries made from them,for use in portable application GB/T 28164.2-2025 Secondary cells and batteries containing alkaline or other non-acid electrolytes—Safety requirements for portable sealed secondary cells,and for batteries made from them,for use in portable applications—Part 2:Lithium systems YY/T 0316-2016 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 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 0709-2009 Medical electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems ISO 2882 ISO 3864-1:2002 ISO 7000:2004 ISO 7010:2011 ISO 9614-1 ISO 80000-1:2009 IEC 60601-1-6 IEC 60730-1:2010 IEC 60851-3:2009 IEC 60851-5:2008 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 YY/T 9706.106-2021 Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems GB/T 2423.5-2019 Environmental testing—Part 2:Test methods—Test Ea and guidance:Shock GB/T 2423.56-2018 Environmental testing—Part 2:Test methods—Test Fh:Vibration, broadband random and guidance GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation 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 31523.1-2015 Safety information identification systems—Part 1:Signs 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 0802-2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of resterilizable medical devices YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer YY/T 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices YY/T 0802.2-2024 Processing of medical device—Information to be provided by the medical device manufacturer—Part 2:Non-critical medical devices YY/T 0916.1-2014 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements YY/T 0916.1-2021 Small-bore connectors for liquids and gases in healthcare applications—Part 1:General requirements YY/T 0916.3-2022 Small-bore connectors for liquids and gases in healthcare applications—Part 3:Connectors for enteral applications YY/T 0916.6-2022 Small-bore connectors for liquids and gases in healthcare applications—Part 6:Connectors for neuraxial applications YY/T 0916.7-2024 Small-bore connectors for liquids and gases in healthcare applications—Part 7:Connectors for intravascular or hypodermic applications YY/T 0916.20-2019 Small-bore connectors for liquids and gases in healthcare applications—Part 20:Common test methods YY 9706.111-2021 Medical electrical equipment—Part 1-11:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment ISO 7000:2014 IEC 62570:2014

ISO 80601-2-55:2018