GB 9706.227-2021 Medical electrical equipment—Part 2-27:Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

GB 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories GB 9706.208-2021 Medical electrical equipment—Part 2-8:Particular requirements for the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV GB 9706.213-2021 Medical electrical equipment—Part 2-13:Particular requirements for the basic safety and essential performance of an anaesthetic workstation GB 9706.216-2021 Medical electrical equipment—Part 2-16:Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment GB 9706.218-2021 Medical electrical equipment—Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment GB 9706.219-2021 Medical electrical equipment—Part 2-19:Particular requirements for the basic safety and essential performance of infant incubators GB 9706.224-2021 Medical electrical equipment—Part 2-24:Particular requirements for the basic safety and essential performance of infusion pumps and controllers GB 9706.225-2021 Medical electrical equipment—Part 2-25:Particular requirements for the basic safety and essential performance of electrocardiographs GB 9706.226-2021 Medical electrical equipment—Part 2-26:Particular requirements for the basic safety and essential performance of electroencephalographs GB 9706.229-2021 Medical electrical equipment—Part 2-29:Particular requirements for the basic safety and essential performance of radiotherapy simulators GB 9706.236-2021 Medical electrical equipment—Part 2-36:Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy GB 9706.239-2021 Medical electrical equipment—Part 2-39:Particular requirements for basic safety and essential performance of peritoneal dialysis equipment GB 9706.243-2021 Medical electrical equipment—Part 2-43:Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures GB 9706.265-2021 Medical electrical equipment—Part 2-65:Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

GB 9706.25-2005 Medical electrical equipment—Part 2:Particular requirements for the safety of electrocardiographic monitoring equipment

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 191-2025 Graphical symbols marking for handling and storage of packages GB 1002-1996 Single phase plugs and socket-outlets for household and similar purposes Types、basic parameters and dimensions GB/T 1002-2008 Single phase plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB/T 1002-2021 Single phase plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB 1002-2024 Single phase plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB 1003-1999 Three phases plugs and socket-outlets for household and similar purposes Types,basic parameters and dimensions GB 1003-2008 Three phases plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB/T 1003-2016 Three phases plugs and socket-outlets for household and similar purposes—Types,basic parameters and dimensions GB 2099.1-1996 Plugs and socket-outlets for household and similar purposes Part 1:General requirements GB/T 2099.1-2008 Plugs and socket-outlets for household and similar purposes—Part 1:General requirements GB/T 2099.1-2021 Plugs and socket-outlets for household and similar purposes—Part 1:General requirements GB/T 2423.2-2008 Environmental testing for electric and electronic products—Part 2:Test methods—Tests B:Dry heat GB/T 2439-2001 Conducting and dissipative rubbers, vulcanized or thermoplastic—Measurement of resistivity GB/T 2941-2006 Rubber—General procedures for preparing and conditioning test pieces for physical test methods GB/T 2941-2025 Rubber—General procedures for preparing and conditioning test pieces for physical test methods GB/T 3667.1-2005 AC motor capacitors—Part 1:General—Performance, testing and rating—Safety requirements—Guide for installation and operation GB/T 3667.1-2016 AC motor capacitors—Part 1:General—Performance,testing and rating—Safety requirements—Guide for installation and operation GB/T 3768-1996 Acoustics—Determination of sound power levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane GB/T 3768-2017 Acoustics—Determination of sound power levels and sound energy levels of noise sources using sound pressure—Survey method using an enveloping measurement surface over a reflecting plane GB/T 3785.1-2010 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 3785.1-2023 Electroacoustics—Sound level meters—Part 1:Specifications GB/T 3785.2-2010 Electroacoustics—Sound level meters—Part 2:Pattern evaluation tests GB/T 3785.2-2023 Electroacoustics—Sound level meters—Part 2:Pattern evaluation tests GB 3836.1-2000 Electrical apparatus for explosive gas atmospheres—Part 1:General requirements GB 3836.1-2010 Explosive atmospheres—Part 1:Equipment—General requirements GB/T 3836.1-2021 Explosive atmospheres—Part 1:Equipment—General requirements GB 3836.5-2004 Electrical apparatus for explosive gas atmosphere—Part 5:Pressurized enclosures"p" GB/T 3836.5-2017 Explosive atmospheres—Part 5:Equipment protection by pressurized enclosure"p" GB/T 3836.5-2021 Explosive atmospheres—Part 5:Equipment protection by pressurized enclosure "p" GB 3836.6-2004 Electrical apparatus for explosive gas atmospheres—Part 6:Oil-immersion"o" GB/T 3836.6-2017 Explosive atmospheres—Part 6:Equipment protection by liquid immersion“o” GB 3836.7-2004 Electrical apparatus for explosive gas atmospheres—Part 7:Powder filling"q" GB/T 3836.7-2017 Explosive atmospheres—Part 7:Equipment protection by powder filling“q” GB/T 4026-1992 Identification of electric equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system GB/T 4026-2004 Basic and safety principles for man-machine interface, marking and identification-identification of equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system GB/T 4026-2010 Basic and safety principles for man-machine interface,marking and identification—Identification of equipment terminals and conductor terminations GB/T 4026-2019 Basic and safety principles for man-machine interface,marking and identification—Identification of equipment terminals,conductor terminations and conductors GB/T 4026-2025 Basic and safety principles for man-machine interface,marking and identification—Identification of equipment terminals,conductor terminations and conductors GB/T 4074.6-2008 Winding wires—Test methods—Part 6:Thermal properties GB/T 4205-2003 Man-machine interface(MMI)—Actuating principles GB/T 4205-2010 Basic and safety principles for man-machine interface(MMI),marking and identification—Actuating principles GB/T 4207-2003 Method for determining the comparative and the proof tracking indices of solid insulating materials under moist conditions GB/T 4207-2012 Method for the determination of the proof and the comparative tracking indices of solid insulating materials GB/T 4207-2022 Method for the determination of the proof and the comparative tracking indices of solid insulating materials GB 4706.1-2005 Household and similar electrical appliances—Safety—Part 1:General requirements GB 4943.1-2011 Information technology equipment—Safety—Part 1:General requirements GB/T 5013.1-2008 Rubber insulated cables of rated voltages up to and including 450/750 V—Part 1:General requirements GB/T 5023.1-2008 Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V—Part 1:General requirements GB/T 5169.16-2002 Fire hazard testing for electric and electronic products—Part 16:50W horizontal and vertical flame test methods GB/T 5169.16-2008 Fire hazard testing for electric and electronic products—Part 16:Test flames—50 W horizontal and vertical flame test methods GB/T 5169.16-2017 Fire hazard testing for electric and electronic products—Part 16:Test flames—50 W horizontal and vertical flame test methods GB/T 5465.2-1996 Graphical symbols for use on electrical equipment GB/T 5465.2-2008 Graphical symbols for use on electrical equipment—Part 2:Graphical symbols GB/T 5465.2-2023 Graphical symbols for use on electrical equipment—Part 2:Graphical symbols GB/T 6346.14-2015 Fixed capacitors for use in electronic equipment—Part 14:Sectional specification—Fixed capacitors for electromagnetic interference suppression and connection to the supply mains GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements GB 8897.4-2002 Primary batteries—Part 4:Safety of lithium batteries GB 8897.4-2008 Primary batteries—Part 4:Safety of lithium batteries GB 8898-2011 Audio,video and similar electronic apparatus—Safety requirements GB 9364.1-1997 Miniature fuses—Part 1:Definitions for miniature fuses and general requirement for miniature fuse-links GB/T 9364.1-2015 Miniature fuses—Part 1:Definitions for miniature fuses and general requirement for miniature fuse-links GB 9706.12-1997 Medical electrical equipment—Part 1:General requirements for safety 3.collateral standard:General requirements for radiation protection in diagnostic X-ray equipment GB/T 11021-2007 Electrical insulation—Thermal classification GB/T 11021-2014 Electrical insulation—Thermal evaluation and designation GB/T 11210-1989 Rubber, vulcanized—Antistatic and conductive products—Determination of electrical resistance GB/T 11210-2014 Rubber,vulcanized or thermoplastic—Antistatic and conductive products—Determination of electrical resistance GB/T 11918.1-2014 Plugs,socket-outlet and couplers for industrial purposes—Part 1:General requirements GB/T 11918.1-2025 Plugs,fixed or portable socket-outlets and appliance inlets for industrial purposes—Part 1:General requirements GB/T 11918.2-2014 Plug, socket-outlets and couplers for industrial purposes—Part 2:Dimensional compatibility and interchangeability requirements for pin and contact-tube accessories GB/T 11918.2-2025 Plugs, fixed or portable socket-outlets and appliance inlets for industrial purposes—Part 2:Dimensional compatibility requirements for pin and contact-tube accessories GB/T 14790.1-2009 Mechanical vibration—Measurement and evaluation of human exposure to hand-transmitted vibration—Part 1:General requirements GB 15092.1-2003 Switches for appliances Part 1:General requirements GB/T 15092.1-2010 Switches for appliances—Part 1:General requirements GB/T 15092.1-2020 Switches for appliances—Part 1:General requirements 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 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals GB/T 16886.9-2001 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products 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 GB/T 4208-2017 Degrees of protection provided by enclosure(IP code) 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 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 9706.202-2021 Medical electrical equipment—Part 2-2:Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-27:2011