Supplement: aa) This particular standard specifies the safety requirements for gamma beam therapy equipment used in human medical practice for radiotherapy purposes, which includes equipment controlled by a programmable electronic system FES (programmable eleotronic system) to select and display operating parameters . bb) This standard applies to equipment that uses sealed radioactive sources to deliver gamma beams at a normal treatment distance (NTD) greater than 5 cm. Special precautions may be required when equipment is operated at closer distances. cc) This particular standard applies to: - equipment used by operators who have special medical application skills and work in accordance with the instructions for use under the supervision of authorized or qualified personnel; - equipment maintained within a predetermined period; -- equipment routinely inspected by the user; -- equipment for clinical applications with special provisions, such as: fixed radiotherapy or moving beam radiotherapy equipment. dd) According to the respective requirements of type test and on-site inspection, this specific standard is applicable to the manufacture and installation of γ-ray therapy equipment. ee) This particular standard only stipulates the requirements for equipment, not for radioactive sources. This specific standard specifies the radiation safety requirements for gamma beam therapy equipment used in human medical practice, in order to ensure the radiation safety of the equipment, enhance the electrical and mechanical safety of the equipment, and also stipulates whether the verification equipment is compatible with this special Tests for compliance with safety requirements. For the type of equipment defined in this standard, the absorbed dose is controlled by the irradiation time. This International Standard does not cover tolerances arising from other methods of controlling absorbed dose.
GB 9706.17-1999 history
2020GB 9706.211-2020 Medical electrical equipment—Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
2009GB 9706.17-2009 Medical electrical equipment.Part 2:Particular requirements for the safety of gamma beam therapy equipment
1999GB 9706.17-1999 Medical electrical equipment--Part 2: Particular requirements for the safety of gamma beam therapy equipment