IEC 62083 : 2.0

MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS

International Electrotechnical Committee

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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

Abstract

Applicable to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems (RTPS): - 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.