DIN EN 62083
Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems (IEC 62083:2009); German version EN 62083:2009
Medizinische elektrische Geräte - Festlegungen für die Sicherheit von Bestrahlungsplanungssystemen (IEC 62083:2009); Deutsche Fassung EN 62083:2009
Overview
The standard applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning system (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. An RTPS is principally a software application. The purpose of this standard is to specify requirements for the software characteristics, the associated documentation and the testing of this software. This standard does not contain requirements for hardware safety, as they depend on the type of hardware. An RTPS is no medical electrical equipment as defined by IEC 60601-1, as it not used in the presence of patients. For this reason, the structure of this standard is different from the structure of the IEC 60601 standard series. In the new version of the standard, adaptations to the latest technical requirements and to the ISO/IEC Directives have been made. The International Standard has been prepared by IEC TC 62/SC 62C "Equipment for radiotherapy, nuclear medicine and radiation dosimetry"), with the German collaboration of NA 080-00-15 GA "Strahlentherapie" ("Radiotherapy").
