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

Publish Date: 2020-12-24 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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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
Pages: 60 pages

Scope

This part of GB 9706 specifies 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).
If a chapter or an article explicitly states that it only applies to ME devices or ME systems, the title and the text of the chapter or article will indicate this. If this is not the case, the relevant chapters or articles apply to both ME devices and ME systems.
Except for 7.2.13 and 8.4.1, the hazards (sources) caused by the intended physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.
This part applies to the basic safety and basic performance of ME devices and ME systems intended for projection-based photography and indirect fluoroscopy. GB 9706.23 applies to ME devices and ME systems used for interventional operations, and the requirements applicable to this dedicated standard are referenced.
This part does not apply to ME devices and ME systems intended for bone or tissue absorption densitometers, computed tomography, mammography, dentistry, or radiotherapy. This part does not apply to radiation therapy simulators.
If a chapter or article applies only to ME devices or only to ME systems, the title and content of the chapter or article will indicate this. If this is not the case, the relevant chapters or articles apply to both ME devices and ME systems.

Development Information

Word Count: 107 Thousand words Pages: 60 pages

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

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