GB 12259-1990
Abolished
GB/Z 169-2026
Active
National standards
GB/Z 169-2026 Medical electrical system—Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems
GB/Z 169-2026 Medical electrical system—Guidelines for safe integration and operation of adaptive external-beam radiotherapy systems
Basic Information
Standard Code:
GB/Z 169-2026
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical radiation equipment
ICS Name:
Treatment equipment
Publish Date:
2026-03-31
Implement Date:
1970-01-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用电器标准化技术委员会(SAC/TC 10)
Pages:
44 pages
Scope
本文件给出了自适应外照射放射治疗系统的安全集成和操作指南,该系统用于治疗分次内刚性移动靶区,所需设备可能来自一个或多个制造商。
本文件适用于自适应外照射放射治疗系统。
Development Information
Drafting Units:
北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、国家药品监督管理局医疗器械技术审评中心、上海理工大学、西安大医集团股份有限公司、上海联影医疗科技股份有限公司、中国人民解放军总医院第一医学中心、中国医学科学院北京协和医院、北京大学第三医院、中国医学科学院肿瘤医院、中核粒子医疗科技有限公司、瓦里安医疗设备(中国)有限公司、医科达(北京)医疗器械有限公司、中广核医疗科技(绵阳)有限公司、山东新华医疗器械股份有限公司
Drafting Persons:
焦春营、谷晓芳、李悦菱、严荣国、林盎春、王理、解传滨、邱杰、杨波、杨瑞杰、门阔、王雨欣、谢士兵、刘宝林、刘仁庆、张新、刘戈、王慧亮、徐翔、陈姗
Referenced Standards
GB 9706.1-1995 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
GB 9706.1-2020 Medical electrical equipment—Part 1:General requirements for basic safety and essential performance
GB/T 18987-2003 Radiotherapy equipment—Coordinates, movements and scales
GB/T 18987-2015 Radiotherapy equipment—Coordinates,movements and scales
GB/T 42062-2022 Medical devices—Application of risk management to medical devices
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971
YY/T 1437-2023 Medical devices—Guidance on the application of GB/T 42062
YY 9706.102-2021 Medical electrical equipment—Part 1-2:General requirements for basic safety and essential performance—Collateral standard:Electromagnetic compatibility—Requirements and tests
YY 9706.264-2022 Medical electrical equipment—Part 2-64:Particular requirements for the basic safety and essential performance of light ion beam medical electrical equipment
YY 9706.268-2022 Medical electrical equipment—Part 2-68:Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators,light ion beam therapy equipment and radionuclide beam therapy equipment
IEC TR 60788
IEC 62570
Adopt standards
IEC TR 62926:2019
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