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GB 9706.244-2020 Active

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

Available format(s)
PDF
Language(s)
Chinese
Publish Date
2020-12-24

Abstract

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 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 expected physiological effects of ME devices or ME systems within the scope of this part are not specifically required in this part.

This part of GB 9706 specifies the special requirements for the basic safety and basic performance of X-ray computed tomography equipment.
This part applies to the basic safety and basic performance of CT scanning devices, also referred to as CT scanning devices in the following text.
If a chapter or 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.
Note 1: See Article 4.2 of the general standard.
The scope of this part is limited to CT scanning devices intended for use on the head and body, characterized by an X-ray source and an image detector, with an enclosure of a ring-shaped ordinary protective shield. It includes the safety requirements for X-ray generators used in CT scanning devices, including the case of the integration of high-voltage generators and X-ray tube assemblies.
Note 2: The requirements for X-ray generators and ancillary equipment previously specified in GB 9706.3 and GB 9706.14 have been included in GB 9706.1—2020 or specialized standards. Therefore, GB 9706.3 and GB 9706.14 are not

General Product Information

Document Type National standards
Standard Status Active
Standard Code GB 9706.244-2020
CCS Medical radiation equipment
ICS X-ray imaging equipment
Implement Date 2023-05-01
Price $ 98
Subtotal $ 98
Tax $ 0.00
Order Total (incl. tax) $ 98

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