EVS-EN 60601-2-1:2002

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 PROTRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
-that, under normal conditions (NC) and in normal use, deliver a radiation beam of X-radiation and or ELECTRON RADIATION having
- NOMINEL ENERGY in the range 1 MeV to 50 MeV,
- MAXIMUM ABSORBED DOSE 3) RATED 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 and
- used within the environmental and electrical supply conditions specified in the technical description.

It also applies to