scope:

Addition:

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 x s^-1 and 1 Gy x 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.

¹⁾ In this Particular Standard, all references to installation refer to installation in the USER'S premises.

²⁾ See ICRP 33 (128) - (134) and (144) - (156).

³⁾ In this Particular Standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.