ÖVE EN 60601-2-1

This particular Standard, with the inclusion of type tests and site tests, applies respectively to the manufacture and some installation aspects of electron accelerators -intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems, -that, under normal conditions and in normal use, deliver a radiation beam of x-radiation and/or electron radiation having *nominal energy in the range 1 MeV to 50 MeV, *maximum absorbed dose rates between 0,001 Gy x s-1 and 1 Gy x s-1 at 1 m from the radiation source, *normal treatment distances between 0,5 m and 2 m from the radiation source and intended to be *for normal use, operated under the authority of appropriately licensed or qualified persons by operators having the required skills for a particular medical application, for particular specified clinical purposes, e.g. stationary radiotherapy or moving beam radiotherapy, *maintained in accordance with the recommendations given in the instructions for use, *subject to regular quality assurance performance and calibration checks by a qualified person, *used within the environmental and electrical supply conditions specified in the technical description.