YY 9706.284-2023 Medical electrical equipment—Part 2-84:Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment

YY 9706.230-2023 Medical electrical equipment—Part 2-30:Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers YY 9706.231-2023 Medical electrical equipment—Part 2-31:Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source YY 9706.246-2023 Medical electrical equipment—Part 2-46:Particular requirements for the basic safety and essential performance of operating tables YY 9706.249-2023 Medical electrical equipment—Part 2-49:Particular requirements for the basic safety and essential performance of multifunction patient monitors YY 9706.256-2023 Medical electrical equipment—Part 2-56:Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement YY 9706.261-2023 Medical electrical equipment—Part 2-61:Particular requirements for the basic safety and essential performance of pulse oximeter equipment YY 9706.277-2023 Medical electrical equipment—Part 2-77:Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment YY 9706.278-2023 Medical electrical equipment—Part 2-78:Particular requirements for basic safety and essential performance of medical robots for rehabilitation,assessment,compensation or alleviation YY 9706.279-2023 Medical electrical equipment—Part 2-79:Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment YY 9706.280-2023 Medical electrical equipment—Part 2-80:Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency

YY 0600.3-2007 Lung ventilators for medical use—Particular requirements for basic safety and essential performance—Part 3:Emergency and transport ventilators

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 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 0664-2020 Medical device software—Software life cycle processes 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 ISO 19054 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 3767-2016 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Engineering methods for an essentially free field over a reflecting plane GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.212-2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators GB 9706.255-2022 Medical electrical equipment—Part 2-55:Particular requirements for the basic safety and essential performance of respiratory gas monitors GB/T 14574-2000 Acoustics—Declaration and verification of noise emission values of machinery and equipment GB/T 19000-2000 Quality management systems—Fundamentals and vocabulary GB/T 19000-2008 Quality management systems—Fundamentals and vocabulary GB/T 19000-2016 Quality management systems—Fundamentals and vocabulary GB/T 19000.2-1998 Quality management and quality assurance standards—Part 2:Generic guidelines for the application of GB/T 19001、GB/T 19002 and GB/T 19003 GB/T 19000.3-2001 Quality management and quality assurance standards—Part 3:Guidelines for the application of GB/T 19001-1994 to the development, supply, installation and maintenance of computer software GB/T 19000.4-1995 Quality management and quality assurance standards—Part 4:Cuide to dependability programme management 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 50751-2012 Technical code for medical gases engineering YY 0339-2002 Suction catheter for use in the respiratory tract YY 0339-2009 Suction catheter for use in the respiratory tract YY/T 0339-2019 Suction catheters for use in the respiratory tract YY/T 0339-2024 Suction catheters for use in the respiratory tract YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators YY/T 0467-2003 Medical devices—Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices YY/T 0467-2016 Medical devices—Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices YY/T 0671-2021 Medical devices—Sleep apnoea breathing therapy—Masks and application accessories YY 0671.1-2009 Sleep apnoea breathing therapy—Part 1:Sleep apnoea breathing therapy devices YY 0671.2-2011 Sleep apnoea breathing therapy—Part 2:Masks and application accessories YY/T 0735.1-2009 Anaesthetic and respiratory equipment—Heat and moisture exchangers(HMEs)for humidifying respired gases in humans—Part 1:HMEs for use with minimum tidal volumes of 250 mL YY/T 0735.2-2010 Anaesthetic and respiratory equipment—Heat and moisture exchangers(HMEs) for humidifying respired gases in humans—Part 2:HMEs for use with tracheostomized patients having minimum tidal volumes of 250 mL YY/T 0753.1-2009 Breathing system filters for anaesthetic and respiratory use—Part 1:Salt test method to assess filtration performance YY/T 0753.2-2009 Breathing system filters for anaesthetic and respiratory use—Part 2:Non-filtration aspects YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases 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 1474-2016 Medical devices—Application of usability engineering to medical devices YY/T 1778.1-2021 Biocompatibility evaluation of breathing gas pathways in healthcare applications—Part 1:Evaluation and testing within a risk management process YY/T 9706.110-2021 Medical electrical equipment—Part 1-10:General requirements for basic safety and essential performance—Collateral Standard: Requirements for the development of physiologic closed-loop controllers 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 YY 9706.274-2022 Medical electrical equipment—Part 2-74:Particular requirements for basic safety and essential performance of respiratory humidifying equipment YY 1040.1-2003 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets YY/T 1040.1-2015 Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets ISO 7000(所有部分) ISO 7396-1 ISO 10524-1 ISO 10524-3 ISO 19223:2019 IEC 62570:2014

ISO 80601-2-84:2020