浅谈质子/碳离子治疗系统技术审查指导原则对于技术要求的编写  

Discussion on the Compilation of Technical Requirements in the Guiding Principles of Technical Review of Proton/Carbon Ion Therapy System

作　　者：金野 何珊珊 JIN Ye;HE Shan-shan(Liaoning Medical Device Test Institute,Liaoning Shenyang 110171)

机构地区：[1]辽宁省医疗器械检验检测院,辽宁沈阳110171

出　　处：《中国医疗器械信息》2020年第13期6-7,10,共3页China Medical Device Information

摘　　要：结合新版《质子/碳离子治疗系统技术审查指导原则》,参照GB 9706.1-2007、GB 15213-2016、IEC62667-2017等标准,总结了质子/碳离子治疗系统在产品技术按要求编写方面易存在的注意事项,以供参考。Combined with the new version of the guiding principles for technical review of proton/carbon ion therapy system,with reference to the standards of GB 9706.1-2007,GB 15213-2016,iec62667-2017,etc.,the precautions for the preparation of proton/carbon ion therapy system in terms of product technology as required are summarized for reference.

关 键 词：新版《质子/碳离子治疗系统技术审查指导原则》 质子/碳离子治疗系统 技术要求 

分 类 号：R197.39[医药卫生—卫生事业管理]