SSH EN 62083:2001

Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems

Scope

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 descriptions. 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.

Related directives

Directives related to this standards.