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YY 0637-2013Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems (English PDF)

医用电气设备放射治疗计划系统的安全要求

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

October 21, 2013

Implementation date

October 1, 2014

Scope

YY 0637-2013 is the English-translated version of 医用电气设备放射治疗计划系统的安全要求.

YY 0637-2013 is the Chinese pharmaceutical industry standard for the safety of radiotherapy treatment planning systems, identical to IEC 62083:2009.

It covers the accompanying documents and general operational safety, including units for distances and radiation quantities, date and time format, protection against unauthorized use and modification, data limits, correctness of data transfer, coordinate systems and data archiving.

Further clauses deal with equipment and brachytherapy source modelling, patient anatomy modelling and contouring, treatment plan preparation, identification and electronic signatures, and the accuracy of absorbed dose calculation algorithms.

The treatment plan report, software versions, use errors and hardware safety are also addressed. It replaces YY 0637-2008. Issued on 21 October 2013, it has applied since 1 October 2014.

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Document preview — YY 0637-2013

National Standard of the People's Republic of China

Replacing: YY 0637-2008

Issued by: National Medical Products Administration of the People's Republic of China

Foreword
Introduction
1 Scope
2 Normative references
3 Terms, definitions and abbreviations
3.1 Terms and definitions
3.2 Abbreviations
4 General
4.1 Development
4.2 Testing during installation
5 ACCOMPANYING DOCUMENTS
6 General requirements for operational safety
6.1 Distances and linear, and angular dimensions
6.2 RADIATION quantities
6.3 Date and time format
6.4 Protection against unauthorized use
6.5 Data limits
6.6 Protection against unauthorized modification
6.7 Correctness of data transfer
6.8 Coordinate systems and scales
6.9 Saving and archiving data
7 RADIOTHERAPY TREATMENT EQUIPMENT MODELLING and BRACHYTHERAPY SOURCE MODELLING
7.1 EQUIPMENT MODEL
7.2 BRACHYTHERAPY SOURCE MODEL
7.3 Dosimetric information
7.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL acceptance
7.5 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL deletion
8 ANATOMY MODELLING
8.1 Data acquisition
8.2 Coordinate systems and scales
8.3 Contouring of regions of interest
8.4 PATIENT ANATOMY MODEL acceptance
8.5 PATIENT ANATOMY MODEL deletion
9 TREATMENT PLANNING
9.1 General requirements
9.2 TREATMENT PLAN preparation
9.3 TREATMENT PLAN identification
9.4 TREATMENT PLAN deletion
9.5 Electronic signatures
10 ABSORBED DOSE distribution calculation
10.1 Algorithms used
10.2 Accuracy of algorithms
11 TREATMENT PLAN report
11.1 Incomplete TREATMENT PLAN report
11.2 Information on the TREATMENT PLAN report
11.3 Transmitted TREATMENT PLAN information
12 General hardware diagnostics
13 Data and code
14 Human errors in software design
15 Change in software versions
16 USE ERRORS
Annex A (Normative) Hardware safety
Annex B (Informative) Imported and exported data
Bibliography

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. […]

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 38 pages — is available in the English PDF.

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Editions of YY 0637

Edition	Title	Revision	Status
YY 0637-2013	Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems	current edition	Current
YY 0637-2008	Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems	previous edition	Superseded

This page sells the current edition, YY 0637-2013. Earlier editions are listed for reference only.

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