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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.
Reģistrācijas numurs (WIID)
46109
Darbības sfēra
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.
