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
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
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
国家药品监督管理局
Pages:
40 pages
Scope
GB 9706的本部分规定了ME设备和ME系统的基本安全和基本性能的通用要求。
本部分适用于医用电气设备和医用电气系统(以下简称ME设备和ME系统)。
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