YY 0637-2013 (YY0637-2013)

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YY 0637-2013
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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
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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 
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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 
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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.
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This Standard was first-time issued in 2008.