DANSK DSF/FPREN IEC 60601-2-1 PDF

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON accelerators, hereafter referred to as ME EQUIPMENT (MEE), in the range 1 MeV to 50 MeV, used for TREATMENT of PATIENTS. NOTE 1 – W hile ELEC TR ON accelerators used for T RE AT ME NT of P ATI EN TS are always MEE, there are times in this document where they are referred to as E XT ER NA L B EA M EQ UIP M E NT (EBE). Usage of E BE does not remove the requirements placed on the ME E but is meant to clarify that the ME E being discussed is the EB E and not some other ME E that may be part of the system configuration. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and som e installation aspects of ELECTRON accelerators and their included equipment used to increase the precision, accuracy and volumetric targeting of the treatment delivery – intended for RADIOTHERAPY in medical practice, including those in which the selection and DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE ELECTRO NIC SUBSYSTEMS (PESS), – that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having <br />• NOMINAL ENERGY in the range 1 MeV to 50 MeV, <br />• maximum ABSORBED DOSE RATES between 0,001 Gy × s–1 and 1 Gy × s–1 at 1 m from the RADIATION SOURCE , <br />• REFERENCE TREATMENT DISTANCES (RTDS) between 0,5 m and 2 m from the RADIATION SOURCE , and – intended to be <br />• 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, <br />• maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE , <br />• subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON. NOTE 2 – In this particular standard, all references to installation refer to installation in the RE SP ONS IB LE OR GA NI ZA T IO N’S premises. NOTE 3 – In this particular standard, all references to A BS OR BED D OS E refer to AB SO RBE D DO SE in water.