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.
BS EN 62083:2001 history
2010BS EN 62083:2010 Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems
2010BS EN 62083:2009 Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
2001BS EN 62083:2001 Medical electrical equipment. Requirements for the safety of radiotherapy treatment planning systems