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

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

Word Count: 107 Thousand words Pages: 57 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

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Adopt standards

IEC 60601-2-54:2018

Related Standards

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