GB 4505-1984
Abolished
GB 9706.245-2020
Active
National standards
force_standard
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 9706.245-2020 Medical electrical equipment—Part 2-45:Particular requirements for the basic safety and essential performance of mammographie X-ray equipment and mammographie stereotactic devices
Price:
$ 86
Basic Information
Standard Code:
GB 9706.245-2020
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
yes
CCS Name:
Medical radiation equipment
ICS Name:
X-ray imaging equipment
Publish Date:
2020-12-24
Implement Date:
2023-05-01
Pages:
44 pages
Scope
This part of GB 9706 stipulates the general requirements for the basic safety and basic performance of ME devices and ME systems.
This part applies to medical electrical equipment and medical electrical systems (hereinafter referred to as ME devices and ME systems).
Development Information
Same series standard
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 9706.212-2020 Medical electrical equipment—Part 2-12:Particular requirements for basic safety and essential performance of critical care ventilators
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 9706.254-2020 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
Replace the following standards
Referenced Standards
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 4208-1993 Degrees of protection provided by enclosure (IP code)
GB/T 4208-2008 Degrees of protection provided by enclosure(IP code)
GB/T 4208-2017 Degrees of protection provided by enclosure(IP code)
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
Adopt standards
IEC 60601-2-45:2015
Related Standards
GB 5579-1985
Abolished
GB 5579-1985 High-voltage cable plug and socket connections for medical X-ray equipment
GB 5665-1985
Abolished
GB 5665-1985 General specification for mechanical units of medical diagnostic X-ray equipment
GB 10151-1988
Abolished
GB 10151-1988 Medical X-ray equipment—Specification for high voltage cable plug and socket connections
GB/T 10149-1988
Active
GB/T 10149-1988 Terminology and symbol for medical X-ray equipment
GB 11239-1989
Replaced