SN EN 62083 : 2001

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