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EVS-EN 62083:2010

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

General information
Valid from 08.04.2010
Base Documents
IEC 62083:2009; EN 62083:2009
Directives or regulations
93/42/EEC Medical devices (MDD)
Directive 93/42/EEC (Medical devices) Notice: This European standard does not necessarily cover the requirements introduced by Directive 2007/47/EC.

Standard history

Status
Date
Type
Name
08.04.2010
Main
This International Standard applies to the design, manufacture and some installation aspects of a radiotherapy treatment planning systems(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; -  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.
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