GB 9706.212-2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators

GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB 9706.103-2020 Medical electrical equipment—Part 1-3:General requirements for basic safety and essential performance—Collateral Standard:Radiation protection in diagnostic X-ray equipment GB 9706.201-2020 Medical electrical equipment—Part 2-1:Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV GB 9706.203-2020 Medical electrical equipment—Part 2-3:Particular requirements for the basic safety and essential performance of short-wave therapy equipment GB 9706.205-2020 Medical electrical equipment—Part 2-5:Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment GB 9706.206-2020 Medical electrical equipment—Part 2-6:Particular requirements for the basic safety and essential performance of microwave therapy equipment GB 9706.211-2020 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment GB 9706.217-2020 Medical electrical equipment—Part 2-17:Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment GB 9706.228-2020 Medical electrical equipment—Part 2-28:Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis GB 9706.237-2020 Medical electrical equipment—Part 2-37:Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment GB 9706.244-2020 Medical electrical equipment—Part 2-44:Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography GB 9706.245-2020 Medical electrical equipment—Part 2-45:Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices GB 9706.254-2020 Medical electrical equipment—Part 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy GB 9706.260-2020 Medical electrical equipment—Part 2-60:Particular requirements for the basic safety and essential performance of dental equipment GB 9706.263-2020 Medical electrical equipment—Part 2-63:Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment

GB 9706.28-2006 Medical electrical equipment—Part 2:Particular requirements for the safety of lung ventilators—Critical care 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 1962.1-2001 Conical fittings with a6%(Luer)taper for syringes, needles and certain other medical equipment Part 1:General requirement GB/T 1962.1-2015 Conical fittings with a 6%(Luer)taper for syringes,needles and certain other medical equipment—Part 1:General requirement GB/T 1962.2-2001 Conical fittings with a 6%(Luer) taper for syringes, needles and certain other medical equipment—Part 2:Lock fittings 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/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/T 4999-2003 Anaesthetic and respiratory equipment—Vocabulary GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance GB/T 31523.1-2015 Safety information identification systems—Part 1:Signs GB 50751-2012 Technical code for medical gases engineering YY 0339-2009 Suction catheter for use in the respiratory tract YY/T 0461-2003 Breathing tubes intended for use with aneasthetic apparatus and ventilators 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 0601-2007 Anaesthetic gas monitors YY 0601-2009 The basic safety and main performance specific requirements for medical electrical equipment respiratory gas monitoring devices YY 0636.1-2008 Medical suction equipment—Part 1:Electrically powered suction equipment—Safety requirements YY/T 0636.1-2021 Medical suction equipment—Part 1:Electrically powered suction equipment YY 0636.3-2008 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or pressure source YY/T 0636.3-2021 Medical suction equipment—Part 3:Suction equipment powered from a vacuum or possitive pressure gas source 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 0786-2010 Respiratory tract humidifiers for medical use—Particular requirements for respiratory humidification systems YY/T 0799-2010 Low-pressure hose assemblies for use with medical gases YY/T 0893-2013 Gas mixers for medical use—Stand-alone gas mixers YY/T 0893-2023 Gas mixers for medical use—Standalone gas mixers YY 0893-2013 Medical gas mixer/independent gas mixer 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 YY/T 1474-2016 Medical devices—Application of usability engineering to medical devices ISO 4871:1996 ISO 7396-1 ISO 10524-1:2006 ISO 14937 ISO 17664 ISO 80601-2-13:2015 IEC 60601-1-6:2010 IEC 60601-1-11 IEC 60601-2-2 IEC 61672-1:2002

ISO 80601-2-12:2011