IEC 62083 pdf download.Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems
1 Scope and object
This International Standard applies to the design, manufacture and some installation aspects of an RTPS – for use in RADIOTHERAPY TREATMENT PLANNING in human medical practice; – that imports data either through input by the OPERATOR or direct from other devices; – that outputs data either in printed form for review or direct to other devices; – and which is intended to be • for NORMAL USE , under the authority of appropriately licensed or QUALIFIED PERSONS , by OPERATORS having the required skills and training; • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE , and • used within the environmental and electrical supply conditions SPECIFIED in the technical description. An RTPS developed by a USER for its own use exclusively is not within the scope of this standard, but it is highly recommended that the principles of this standard be applied in its creation and use. If such an RTPS is provided to another USER in which the developers do not directly control its use, and is represented as being suitable for use, then the developers assume the role of MANUFACTURER , and this standard applies. An RTPS is principally a software application, and the object of this standard is to establish the requirements for features, associated documentation, and testing of the software. Requirements for SAFETY of hardware are not included in this standard, as they vary with the nature of the hardware. See 3.1 and annex A for hardware requirements.
3 Relationship to other standards
3.1 Hardware SAFETY standards Requirements for the SAFETY of hardware, such as for protection against electric shock and fire, and to assure for ELECTROMAGNETIC COMPATIBILITY , are not included in this standard. S AFETY requires that these subjects be addressed by the MANUFACTURER separately through compliance with an appropriate standard, depending upon the nature and environment of the hardware used for the RTPS . See annex A for hardware SAFETY standards. 3.2 Software SAFETY standards An RTPS is principally a software application for a medical purpose. IEC Collateral Standard 60601-1-4 applies (see clause 16). 3.3 IEC 61217 Radiotherapy equipment – Coordinates, movements and scales IEC 61217 gives guidance on the designation of EQUIPMENT movements, the marking of scales, their zero position and the direction of movement with increasing value. The means of applying IEC 61217 are specified in appropriate clauses and subclauses of this standard.
4.2 BRACHYTHERAPY SOURCE MODEL / BRACHYTHERAPY SOURCE MODELLING all physical, geometric and RADIATION parameters required to plan a course of RADIOTHERAPY for a particular BRACHYTHERAPY RADIOACTIVE SOURCE . The process of establishing the BRACHYTHERAPY SOURCE MODEL is referred to as ” BRACHYTHERAPY SOURCE MODELLING ” 4.3 PATIENT ANATOMY MODEL / ANATOMY MODELLING all physical and anatomical parameters required to plan a course of RADIOTHERAPY for a particular PATIENT . The process of establishing the PATIENT ANATOMY MODEL is referred to as ” ANATOMY MODELLING ” 4.4 TREATMENT PLAN / TREATMENT PLANNING all PATIENT and dosimetric information that is intended for use by appropriately QUALIFIED PERSON s for the purpose of prescribing or administering RADIOTHERAPY treatment. A TREATMENT PLAN includes information transmitted to other EQUIPMENT for which the use of the information for prescribing or administering IRRADIATION is indirect. A printed or plotted TREATMENT PLAN is referred to as a TREATMENT PLAN report 4.5 RADIOTHERAPY TREATMENT PLANNING SYSTEM ( RTPS ) a device, usually a PROGRAMMABLE ELECTRONIC SYSTEM including its associated peripherals, that is used to simulate the application of RADIATION to a PATIENT for a proposed RADIOTHERAPY treatment. It usually, but not necessarily, provides estimations of ABSORBED DOSE distribution in human tissue using a particular algorithm or algorithms. These algorithms provide simulations of RADIATION that is typically from, but not necessarily limited to, MEDICAL ELECTRON ACCELE – RATORS , GAMMA BEAM THERAPY EQUIPMENT , or RADIOACTIVE SOURCES when BRACHYTHERAPY is planned.