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YY 0637-2013 English PDF

YY 0637-2013_English: PDF (YY0637-2013)
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY 0637-2013English150 Add to Cart 0--9 seconds. Auto-delivery Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems Valid YY 0637-2013
YY 0637-2008English919 Add to Cart 4 days [Need to translate] Medical electrical equipment. Requirement for the safety of radiotherapy treatment planning system Obsolete YY 0637-2008
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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 & Pharmaceutical Industry Standard
Classification of Chinese Standard C43
Classification of International Standard 11.040.60
Word Count Estimation 29,244
Older Standard (superseded by this standard) YY 0637-2008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
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Technical Committee of Standardization for medical electrical radiation therapy, nuclear medicine and radiation Standardization Technical Committee dosimetry equipment
Regulation (derived from) State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Proposing organization State Food and Drug Administration
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,


YY 0637-2013                                                                                             Page 1 of 39  YY ICS 11.040.60 C 43 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA YY 0637-2013 / IEC 62083.2009 Replacing YY 0637-2008 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083.2009, IDT) ISSUED ON. OCTOBER 21, 2013 IMPLEMENTED ON. OCTOBER 1, 2014 Issued by. State Food and Drug Administration                                                                                             Page 2 of 39  Table of Contents Foreword ... 4  Introduction ... 6  1  Scope ... 8  2  Normative references ... 8  3  Terms, definitions and abbreviations... 9  3.1  Terms and definitions ... 9  3.2  Abbreviations ... 11  4  General ... 11  4.1  Development ... 11  4.2  Testing during installation ... 11  5  ACCOMPANYING DOCUMENTS ... 12  6  General requirements for operational safety ... 13  6.1  Distances and linear, and angular dimensions ... 13  6.2  RADIATION quantities ... 14  6.3  Date and time format ... 14  6.4  Protection against unauthorized use ... 14  6.5  Data limits ... 15  6.6  Protection against unauthorized modification ... 16  6.7  Correctness of data transfer ... 16  6.8  Coordinate systems and scales ... 17  6.9  Saving and archiving data ... 17  7  RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and BRACHYTHERAPY SOURCE MODELLING ... 17  7.1  EQUIPMENT MODEL ... 17  7.2  BRACHYTHERAPY SOURCE MODEL ... 19  7.3  Dosimetric information ... 19  7.4  EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance   20  7.5  EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion ... 21  8  ANATOMY MODELLING ... 21  8.1  Data acquisition ... 21  8.2  Coordinate systems and scales ... 22  8.3  Contouring of regions of interest... 23  8.4  PATIENT ANATOMY MODEL acceptance ... 23  8.5  PATIENT ANATOMY MODEL deletion ... 24                                                                                              Page 3 of 39  9  TREATMENT PLANNING ... 24  9.1  General requirements ... 24  9.2  TREATMENT PLAN preparation ... 24  9.3  TREATMENT PLAN identification ... 25  9.4  TREATMENT PLAN deletion ... 25  9.5  Electronic signatures ... 26  10  ABSORBED DOSE distribution calculation ... 26  10.1  Algorithms used ... 26  10.2  Accuracy of algorithms ... 26  11  TREATMENT PLAN report ... 28  11.1  Incomplete TREATMENT PLAN report ... 28  11.2  Information on the TREATMENT PLAN report ... 28  11.3  Transmitted TREATMENT PLAN information ... 29  12  General hardware diagnostics ... 30  13  Data and code ... 30  14  Human errors in software design ... 30  15  Change in software versions ... 31  16  USE ERRORS ... 32  Annex A (Normative) Hardware safety ... 33  Annex B (Informative) Imported and exported data ... 36  Bibliography ... 37  Index of defined terms ... 38                                                                                              Page 4 of 39  Foreword  This Standard is drafted according to the rules specified in GB/T 1.1-2009. The Standard replaces YY0637-2008 Medical Electrical Equipment – Requirements for the Safety of Radiotherapy Treatment Planning Systems. Compared with YY0637-2008, the main technical changes of this Standard are as follows. — Add 3.2 Abbreviations; — Delete Chapter 3 of the previous standard; — Split the 8.1 of the previous standard INTO 7.1 and 7.2 of this Standard; — Delete Chapter 14 of the previous standard. The Standard is identical to IEC62083.2009 Medical Electrical Equipment – Requirements for the Safety of Radiotherapy Treatment Planning Systems. Our national documents that are consistent with the international documents of the Normative References of this Standard are as follows. [Translator. NIL here] For ease of use, this Standard is modified as follows. -- Modify the “international standard” to “this Standard”; -- Replace the comma “,” with a decimal point “.”; -- Delete the foreword of international standard. Please note that some contents of this Document may involve patents. The issuing authority of this Document does not undertake the responsibility of identifying these patents. This Standard was proposed by the State Food and Drug Administration. This Standard shall be under the jurisdiction of National Standardization Technical Committee of Medical Appliances Radiotherapy and Technical Committee of Nuclear Medicine and Radiation Dosimetry Equipment (SAC/TC10/SC3). Main drafting organizations of this Standard. Beijing Institute of Medical Device Testing, Shandong Shinva Medical Instrument Co., Ltd., and Shanghai Song’s Lab Science and Technology Development Co., Ltd. Main drafters of this Standard. Song Lianyou, Wang Peichen, Yin Xiaohui, and Cao Guogang.                                                                                             Page 5 of 39  This Standard was first-time issued in 2008. ......