60601-2-1 (REDLINE + STANDARD)-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 (Edition 3.1 Consolidated Reprint)
Appareils électromédicaux – Partie 2-1: Exigences particulières de sécurité de base et de performances essentielles pour les accélérateurs d'électrons dans la gamme de 1 MeV à 50 MeV (Edition 3.1 Consolidated Reprint)
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 (Edition 3.1 Consolidated Reprint) 是非强制性国家标准，您可以免费下载前三页
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 ?C 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)@ ?C 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?C1 and 1 Gy ?? s?C1 at 1 m from the RADIATION SOURCE@ NORMAL TREATMENT DISTANCES (NTDs) between 0@5 m and 2 m from the RADIATION SOURCE@ and ?C 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. 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.