IEC 62083:2009
Superseded
View Superseded by
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Hardcopy , PDF
English - French
09-23-2009
12-09-2025
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
Index of defined terms
IEC 62083:2009 applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems:
- for use in radiotherapy treatment planning in human medical practice;
- that imports data either through input by the operator or directly from other devices;
- that outputs data either in printed form for review or directly to other devices;
and which is intended to be:
a) for normal use, under the authority of appropriately licensed or qualified persons, by operators having the required skills and training;
b) maintained in accordance with the recommendations given in the instructions for use, and
c) used within the environmental and electrical supply conditions specified in the technical description.
This second edition replaces the first edition of IEC 62083, published in 2000. This edition constitutes a technical revision, which brings this standard in line with changes to the other standards referred to in this standard.
| Committee |
TC 62/SC 62C
|
| DevelopmentNote |
Stability Date: 2019. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
59
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NF EN 62083 : 2010 | Identical |
| GOST R IEC 62083 : 2013 | Identical |
| NBN EN 62083 : 2010 | Identical |
| NEN EN IEC 62083 : 2010 | Identical |
| I.S. EN 62083:2009 | Identical |
| BS EN 62083:2009 | Identical |
| CEI EN 62083 : 2011 | Identical |
| EN 62083:2009 | Identical |
| DIN EN 62083:2011-01 | Identical |
| IS/IEC 62083 : 2009 | Identical |
| JIS T 62083:2017 | Identical |
| UNE-EN 62083:2010 | Identical |
| PN EN 62083 : 2010 | Identical |
| BS EN 61300-2-12:2005 | Identical |
A newer version of this standard is available.
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