IEC 62083:2009
Current
The latest, up-to-date edition.
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English - French, Spanish, Castilian
23-09-2009
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 |
Current
|
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 |
SN EN 62083 : 2001 | Identical |
PN EN 62083 : 2010 | Identical |
UNE-EN 62083:2010 | Identical |
10/30206488 DC : 0 | BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
I.S. EN IEC 62667:2018 | MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
CSA C22.2 No. 60601.2.17 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
EN 61217:2012 | Radiotherapy equipment - Coordinates, movements and scales |
16/30216785 DC : 0 | BS EN 62667 - MEDICAL ELECTRICAL EQUIPMENT - MEDICAL LIGHT ION BEAM EQUIPMENT - PERFORMANCE CHARACTERISTICS |
BS EN 60601-2-68:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
CEI EN 62274 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
I.S. EN 61217:2012 | RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES (IEC 61217:2011 (EQV)) |
I.S. EN 60601-2-17:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLY CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
10/30206860 DC : 0 | BS EN 61217 - RADIOTHERAPY EQUIPMENT - COORDINATES, MOVEMENTS AND SCALES |
BS ISO 16142-1:2016 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
02/564070 DC : DRAFT SEP 2002 | BS EN 60601-2-17 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE SAFETY OF AUTOMATICALLY-CONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
CSA C22.2 No. 60601-2-68 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
CEI EN 60601-2-17 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-17: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATICALLYCONTROLLED BRACHYTHERAPY AFTERLOADING EQUIPMENT |
BS EN 60601-2-17:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
IEC 60601-2-17:2013 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
I.S. EN 62274:2005 | MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS |
PD IEC TR 60788:2004 | Medical electrical equipment. Glossary of defined terms |
BS EN 62274:2005 | Medical electrical equipment. Safety of radiotherapy record and verify systems |
BS EN IEC 62667:2018 | Medical electrical equipment. Medical light ion beam equipment. Performance characteristics |
EN 60601-2-68:2015 | Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment |
EN IEC 62667:2018 | Medical electrical equipment - Medical light ion beam equipment - Performance characteristics |
IEC 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
BS EN 61217:2012 | Radiotherapy equipment. Coordinates, movements and scales |
DIN 6814-8:2016-08 | TERMS IN THE FIELD OF RADIOLOGICAL TECHNIQUE - PART 8: RADIOTHERAPY |
I.S. EN 60601-2-68:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
NF EN 60601-2-68 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-68: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY-BASED IMAGE-GUIDED RADIOTHERAPY EQUIPMENT FOR USE WITH ELECTRON ACCELERATORS, LIGHT ION BEAM THERAPY EQUIPMENT AND RADIONUCLIDE BEAM THERAPY EQUIPMENT |
EN 62274:2005 | Medical electrical equipment - Safety of radiotherapy record and verify systems |
EN 60601-2-17:2015 | Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment |
IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
IEC 61000-4-1:2006 | Electromagnetic compatibility (EMC) - Part 4-1: Testing and measurement techniques - Overview of IEC 61000-4 series |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC TR 60788:2004 | Medical electrical equipment - Glossary of defined terms |
IEC 61000-4-4:2012 RLV | Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test |
IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
IEC 60601-2-1:2009+AMD1:2014 CSV | Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
IEC 61217:2011 | Radiotherapy equipment - Coordinates, movements and scales |
IEC 60601-2-11:2013 | Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment |
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