GB 9706.217-2020

Active

Medical electrical equipment—Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment

医用电气设备 第2-17部分:自动控制式近距离治疗后装设备的基本安全和基本性能专用要求

Standard Type
GB
ICS
11.040.60
CCS
C 43
Status
Active
Issue Date
2020-12-24
Implementation
2023-05-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies safety and performance requirements for automatically-controlled brachytherapy afterloading equipment used in cancer treatment. It applies to medical electrical devices that deliver radiation sources through catheters or applicators placed inside or near a tumor, ensuring safe operation during procedures like cervical, prostate, or breast brachytherapy. The standard is used by manufacturers, healthcare facilities, and testing laboratories to verify device compliance with essential safety and performance criteria.

Related Standards

Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.