scope:

This Particular Standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation1) aspects of ELECTRON ACCELERATORS2) - 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 (PESS), - that, under NORMAL CONDITIONS (NC) 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 DOSE3) RATES between 0,001 Gy ´ s-1 and 1 Gy ´ s-1 at 1 m from the RADIATION SOURCE, · NORMAL TREATMENT DISTANCES (NTDs) 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.