GB 9706.17-2009 Medical electrical equipment—Part 2:Particular requirements for the safety of gamma beam therapy equipment

Scope

Addition:
aa) This dedicated standard specifies the safety requirements for gamma beam therapy equipment used for radiation therapy purposes in human medical practice, including devices controlled by a programmable electronic system (PES) for selecting and displaying operating parameters;
bb) This dedicated standard applies to devices that use sealed radioactive sources to provide gamma beams at a normal treatment distance (NTD) greater than 5 cm. When the device operates at a closer distance, special precautions may be required;
This dedicated standard also applies to multi-source stereotactic radiosurgery and radiotherapy (MSSR) equipment, which irradiates a common center using more than one sealed radioactive source simultaneously. The sources can be stationary or mobile;
cc) This dedicated standard applies to:
——Devices used by operators with special medical application skills and in accordance with the instructions for use, under the supervision of authorized or qualified personnel;
——Devices repaired within a predetermined period;
——Devices subject to routine inspections by users;
——Devices with special requirements for clinical applications, such as fixed radiation therapy or mobile beam radiation therapy equipment;
dd) According to the requirements of type testing and on-site inspection, this dedicated standard applies to the manufacture and installation of gamma beam therapy equipment;
ee) This dedicated standard only specifies the requirements for the equipment, and does not stipulate the requirements for radioactive sources.

Development Information

Same series standard

Replace the following standards

Superseded by the following standards

Adopt standards

Related Standards