EN 60601-2-29:1995

Medical electrical equipment - Part 2: Particular requirements for the safety of radiotherapy simulators EN 60601-2-29:1995

Scope

This clause of the General Standard applies, except as follows: 1.1 Scope Addition: This Standard applies to RADIOTHERAPY SIMULATORS which use diagnostic X-RAY EQUIPMENT to simulate physically a therapeutic RADIATION BEAM. So that the TREATMENT VOLUME to be irradiated during RADIOTHERAPY can be localized, and the position and size of the therapeutic RADIATION FIELD can be confirmed. This Standard applies to RADIOTHERAPY SIMULATORS using HIGH-VOLTAGE GENERATORS complying with EN 60601-2-7. This Standard applies to RADIOTHERAPY SIMULATORS intended exclusively for RADIOTHERAPY simulation as a prelude to intended RADIOTHERAPY, and not for any other purpose such as general diagnostic examinations. This Standard applies to RADIOTHERAPY SIMULATORS comprising the following parts: a} A system for producing a RADIATION BEAM not exceeding 400 kV which simulates the geometry of the RADIOTHERAPY RADIATION BEAM. b) A system for producing images of the transmitted X-RAY BEAM, for example either by RADIOGRAPHY or by RADIOSCOPY. C) An assembly to control the size of the RADIATION BEAM and to DELINEATE the intended treatment area. d) A mechanical structure which physically simulates the geometry and motions of the RADIOTHERAPY EQUIPMENT and supports the imaging system. e) A PATIENT SUPPORT system.

Related legislation

Legislation related to this standard