EN 62083:2001

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

Publication date:   Mar 19, 2004

General information

99.60 Withdrawal effective   Nov 1, 2012

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.60   Therapy equipment

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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 legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 62083:2001
99.60 Withdrawal effective
Nov 1, 2012

REVISED BY

PUBLISHED
EN 62083:2009