scope:

201.1.1 Scope
Subclause 1.1 of the General Standard is replaced by:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of PATIENTS.
If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.
This Particular Standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively
to the manufacture and some installation2) 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 (PESS),
- that, under NORMAL CONDITIONS (NC) and in NORMAL USE, deliver a RADIATION BEAM of XRADIATION 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.