GB 4505-1984
Abolished
GB 9706.254-2020
Active
National standards
force_standard
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 9706.254-2020 Medical electrical equipment—Part 2-54:Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
Basic Information
Standard Code:
GB 9706.254-2020
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:
57 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)。
如果一章或一条明确指出仅适用于ME设备或ME系统,标题和 章或条的正文会说明。如果不是这种情况,与此相关的章或条同时适用于ME设备和ME系统。
除7.2.13和8.4.1外,本部分范围内的ME设备或ME系统的预期生理效应所导致的危险(源)在本部分中没有具体要求。
本部分适用于预期用于投影方式的摄影和间接透视的ME设备和ME系统的基本安全和基本性能。GB 9706.23适用于用于介入操作的ME设备和ME系统,并且引用本专用标准适用的要求。
本部分不适用于预期用于骨或组织吸收密度仪、计算机体层摄影、乳腺摄影、牙科或放疗用的ME设备和ME系统。本部分不适用于放射治疗模拟机。
如果某一章条是仅适用于ME设备,或仅适用于ME系统,章条的标题和内容会予以说明。如果非此种情况,章条既适用于ME设备又适用于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 9706.245-2020 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 9706.260-2020 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
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
Adopt standards
IEC 60601-2-54:2018
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