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Chinese Standard: YY 0637-2013

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Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems


Standard in brief
Scope of Application:  
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;

Basic information
Standard No:YY 0637-2013
Standard Name:医用电气设备 放射治疗计划系统的安全要求
English Name:Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems
Standard Status:现行
Release Date:2008-04-25
Effective Date:2014-10-01
Language of Publication:中文简体

Standard Classification
ICS Number:11.040.60
CCS Number:C43

Related Standards
Referenced Standards:GB 9706.17-2009,IEC 60601-1:2005,IEC 60601-1-2,IEC 60601-2-1:2009,IEC/TR 60788:2004,IEC 60950-1,IEC 61000-4-1,IEC 61000-4-2,IEC 61000-4-3,IEC 61000-4-4,IEC 61217,IEC 62304,IEC 62366:2007,ICRU Report 42:1987
Adopted Standards:IEC 62083:2009
Adopted Standard Name:《医用电气设备 放射治疗计划系统的安全要求》
Adoption Level:IDT

Publication Information
Number of pages:32
Number of words:48 K
Format:大16
Edition:1
Color Pages:0
Electronic Version:Yes
Color Images:No
Print Publication Date:2014-01-01

Standard Revision Information
Has Amendment:No

Other Information
Application Dept:国家食品药品监督管理总局
Standard Type:QT
Standard Attribute:YY
Other Standard Number:0637
Drafter:宋连有、王培臣、尹晓辉、曹国刚
Drafting Organization:北京市医疗器械检验所、山东新华医疗器械股份有限公司、上海世鹏实验室科技发展有限公司
Management Organization:全国医用电器标准化技术委员会放射治疗、核医学和放射剂量学设备分技术委员会(SAC/TC 10/SC 3)
Proposing Department:国家食品药品监督管理总局

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