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
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.