E DIN EN 60601-2-64/A1 VDE 0750-2-64/A1:2025-11

The use of light ion beam Me equipment for radiotherapy purposes may expose Patients to danger if the Me equipment fails to deliver the required dose to the Patient, or if the Me equipment design does not satisfy standards of electrical and mechanical safety.
The Me equipment may also cause danger to persons in the vicinity if the Me equipment itself fails to contain the ratiation adequately or if there are inadequacies in the design of the treatment room.
This particular standard, with the inclusion of type test and site tests, applies respectively to the manufacture and some installation aspects of light ion beam equipment:
- 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, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n,
- intended to be, under 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 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.