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IEC 62083:2009

Current

Current

The latest, up-to-date edition.

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English - French, Spanish, Castilian

Published date

09-23-2009

US$220.00
Excluding Tax where applicable

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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