SN EN 62083 : 2001
Current
The latest, up-to-date edition.
MEDICAL ELECTRICAL EQUIPMENT - REQUIREMENTS FOR THE SAFETY OF RADIOTHERAPY TREATMENT PLANNING SYSTEMS
12-01-2013
1 Scope and object<br>2 Normative references<br>3 Relationship to other standards<br> 3.1 Hardware SAFETY standards<br> 3.2 Software SAFETY standards<br> 3.3 IEC 61217 Radiotherapy equipment -<br> Coordinates, movements and scales<br>4 Terminology and definitions<br>5 General requirements for tests<br> 5.1 Testing during development<br> 5.2 Testing during installation<br>6 ACCOMPANYING DOCUMENTS<br>7 General requirements for operational safety<br> 7.1 Distances and linear dimensions<br> 7.2 RADIATION quantities<br> 7.3 Date and time format<br> 7.4 Protection against unauthorized use<br> 7.5 Data limits<br> 7.6 Protection against unauthorized modification<br> 7.7 Correctness of data transfer<br> 7.8 Coordinate systems and scales<br> 7.9 Saving and archiving data<br>8 RADIOTHERAPY TREATMENT EQUIPMENT and<br> BRACHYTHERAPY SOURCE MODELLING<br> 8.1 General<br> 8.2 Dosimetric information<br> 8.3 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL<br> acceptance<br> 8.4 EQUIPMENT MODEL, BRACHYTHERAPY SOURCE MODEL<br> deletion<br>9 ANATOMY MODELLING<br> 9.1 Data acquisition<br> 9.2 Coordinate systems and scales<br> 9.3 Contouring of regions of interest<br> 9.4 PATIENT ANATOMY MODEL acceptance<br> 9.5 PATIENT ANATOMY MODEL deletion<br>10 TREATMENT PLANNING<br> 10.1 General requirements<br> 10.2 TREATMENT PLAN preparation<br> 10.3 TREATMENT PLAN identification<br> 10.4 TREATMENT PLAN deletion<br> 10.5 Electronic signatures<br>11 ABSORBED DOSE distribution calculation<br> 11.1 Algorithms used<br> 11.2 Accuracy of algorithms<br>12 TREATMENT PLAN report<br> 12.1 Incomplete TREATMENT PLAN report<br> 12.2 Information on the TREATMENT PLAN report<br> 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> A.1 General requirements<br> A.2 Completeness of hardware SAFETY<br> A.3 Completeness of ACCOMPANYING DOCUMENTS<br>Annex B (informative) Imported and exported data<br>Annex C (normative) Terminology - Index of defined<br> terms<br>Annex ZA (normative) Normative references to<br> international publications with their<br> corresponding European publications
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