IEC 62083-2009 pdf Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems

4 General 4.1 Development Compliance with IEC 62304 requires identification of HAZARDS , assessment of their RISKS , and appropriate verification and validation of RISK CONTROLS . Demonstration of compliance with the requirements of this standard shall be included as part of the above processes, with explicit reference to each requirement of this standard. Compliance data shall be retained by the MANUFACTURER as a permanent record. Each test shall include a protocol containing all the necessary input data, sufficient detail to provide for exact reproducibility, and the expected result. A statement of compliance to this standard shall be included in the technical description. Compliance is checked by inspection of the records of the MANUFACTURER . 4.2 Testing during installation The MANUFACTURER shall provide an installation test document as part of the technical description that includes, as a minimum, performance of the ABSORBED DOSE distribution calculation algorithm tests given in 1 0.2 and tests of geometric relationships. The tests shall also demonstrate correct functioning of the RTPS hardware components and their ability to achieve predetermined results when performing TREATMENT PLANNING functions. Due to the complexity of TREATMENT PLANNING functions and the possible use of configurations beyond those specified by the MANUFACTURERS , it is usually not possible for the MANUFACTURER to demonstrate complete fitness for use of the RTPS at time of installation. The technical description shall provide explicit warnings to the RESPONSIBLE ORGANIZATION to add additional tests specific for the installation of the RTPS at the RESPONSIBLE ORGANIZATION .
It shall be possible for the OPERATOR to perform all TREATMENT PLANNING functions with the scales and coordinates of RADIOTHERAPY TREATMENT ME EQUIPMENT displayed according to the IEC 61 21 7 convention. It should also be possible for the OPERATOR to perform all TREATMENT PLANNING functions with the scales and coordinates of ME EQUIPMENT displayed according to the customization for the particular ME EQUIPMENT performed during EQUIPMENT MODELLING . In either case, the TREATMENT PLAN reports used for RADIOTHERAPY TREATMENT prescription shall show the scales and coordinates of ME EQUIPMENT according to the customization for the particular ME EQUIPMENT performed during EQUIPMENT MODELLING . The method of display of scales shall be explained in the INSTRUCTIONS FOR USE . Compliance is checked by testing and by inspection of the DISPLAY , output information and ACCOMPANYING DOCUMENTS .