NBN EN 62083 : 2010

1 Scope and object
2 Normative references
3 Relationship to other standards
   3.1 Hardware SAFETY standards
   3.2 Software SAFETY standards
   3.3 IEC 61217 Radiotherapy equipment -
        Coordinates, movements and scales
4 Terminology and definitions
5 General requirements for tests
   5.1 Testing during development
   5.2 Testing during installation
6 ACCOMPANYING DOCUMENTS
7 General requirements for operational safety
   7.1 Distances and linear dimensions
   7.2 RADIATION quantities
   7.3 Date and time format
   7.4 Protection against unauthorized use
   7.5 Data limits
   7.6 Protection against unauthorized modification
   7.7 Correctness of data transfer
   7.8 Coordinate systems and scales
   7.9 Saving and archiving data
8 RADIOTHERAPY TREATMENT EQUIPMENT and
   BRACHYTHERAPY SOURCE MODELLING
   8.1 General
   8.2 Dosimetric information
   8.3 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL
        acceptance
   8.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL
        deletion
9 ANATOMY MODELLING
   9.1 Data acquisition
   9.2 Coordinate systems and scales
   9.3 Contouring of regions of interest
   9.4 PATIENT ANATOMY MODEL acceptance
   9.5 PATIENT ANATOMY MODEL deletion
10 TREATMENT PLANNING
   10.1 General requirements
   10.2 TREATMENT PLAN preparation
   10.3 TREATMENT PLAN identification
   10.4 TREATMENT PLAN deletion
   10.5 Electronic signatures
11 ABSORBED DOSE distribution calculation
   11.1 Algorithms used
   11.2 Accuracy of algorithms
12 TREATMENT PLAN report
   12.1 Incomplete TREATMENT PLAN report
   12.2 Information on the TREATMENT PLAN report
   12.3 Transmitted TREATMENT PLAN information
13 General hardware diagnostics
14 Arithmetic processor
15 Data and code
16 Human errors in software design
17 Change in software versions
18 Human errors in use
Annex A (normative) Hardware safety
        A.1 General requirements
        A.2 Completeness of hardware SAFETY
        A.3 Completeness of ACCOMPANYING DOCUMENTS
Annex B (informative) Imported and exported data
Annex C (normative) Terminology - Index of defined
        terms
Annex ZA (normative) Normative references to
         international publications with their
         corresponding European publications

Applicable to design, manufacture and installation of RTPS for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice, import of data either through input by OPERATOR or directly from other devices and output data either in printed form or directly to other devices. It is meant for NORMAL USE by OPERATORS having required skills and training, maintained as recommended in INSTRUCTIONS FOR USE and used within the environmental and electrical supply conditions specified in technical description.