YY 0637-2013: Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

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Basic Data

Standard ID	YY 0637-2013 (YY0637-2013)
Description (Translated English)	Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Sector / Industry	Medical Device and Pharmaceutical Industry Standard
Classification of Chinese Standard	C43
Classification of International Standard	11.040.60
Word Count Estimation	29,262
Older Standard (superseded by this standard)	YY 0637-2008
Quoted Standard	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 Standard	IEC 62083-2009; IDT
Regulation (derived from)	State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard applies to: radiation treatment planning system (hereinafter referred to as the RTPS) design, manufacture, installation and use, etc, applied in medical practice radiation therapy treatment planning, input input data either by the operator,