IEC 60601-2-1 3.1 Edition, July 1, 2014
Medical electrical equipment – Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
Additional Comments: BILINGUAL * CONSOLIDATED REPRINT
Published By:International Electrotechnical Commission (IEC)
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.
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 PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS 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 DOSE 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,
– intended to be
NOTE 1 In this particular standard, all references to installation refer to installation in the RESPONSIBLE ORGANIZATION'S premises.
NOTE 2 In this particular standard, all references to ABSORBED DOSE refer to ABSORBED DOSE in water.