Standard No.:	YY 0637-2013
English Name:	Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems
Chinese Name:	医用电气设备 放射治疗计划系统的安全要求
Chinese Classification:	C43    Medical radiographic equipment
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.60 11.040.60    Therapy equipment 11.040.60
Issued by:	China Food and Drug Administration
Issued on:	2013-10-21
Implemented on:	2014-10-1
Status:	valid
Superseding:	YY 0637-2008 Medical electrical equipment-Requirement for the safety of Radiotherapy treatment planning system
Language:	English
File Format:	PDF
Word Count:	14000 words
Price(USD):	140.00
Delivery:	via email in 1~3 business day

本标准适用于放射治疗计划系统(以下简称RTPS)的设计、制造、安装和使用等方面;
———应用于医学实践中放射治疗的治疗计划设计;
———输入的数据既可通过操作者输入,也可直接从其他设备获取;
———输出数据既可打印文图阅览,也可直接输出到其他设备;
———并预期:
● 在适当的许可或合格人员的授权下,由具备所需技能和培训的操作者正常使用;
● 按照使用说明书中推荐的方法维护,并;
● 在技术说明书中所规定的环境和供电条件使用。