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IEC 60601-2-1-ed.4.0
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
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STANDARD published on 28.10.2020
The information about the standard:
Designation standards: IEC 60601-2-1-ed.4.0
Publication date standards: 28.10.2020
SKU: NS-1008665
The number of pages: 232
Approximate weight : 727 g (1.60 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 60601-2-1-ed.4.0 :
IEC 60601-2-1:2020 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. NOTE 1 While ELECTRON ACCELERATORS used for TREATMENT of PATIENTS are always ME EQUIPMENT, there are times in this document where they are referred to as EXTERNAL BEAM EQUIPMENT (EBE). Usage of EBE does not remove the requirements placed on the ME EQUIPMENT but is meant to clarify that the ME EQUIPMENT being discussed is the EBE and not some other ME EQUIPMENT that may be part of the system configuration. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies to the manufacture and some 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 ELECTRONIC SUBSYSTEMS (PESS), – that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION or ELECTRON RADIATION having • NOMINAL ENERGY in the range 1 MeV to 50 MeV, • maximum ABSORBED DOSE RATES between 0,001 Gy x s–1 and 1 Gy x s–1 at the ERP from the RADIATION SOURCE, and • REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION SOURCE; and – intended to be • for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by QUALIFIED PERSONS appropriately licensed or having the required skills for a particular medical application, for particular SPECIFIED clinical purposes, • maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE, and • subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED PERSON. IEC 60601-2-1:2020 cancels and replaces the third edition published in 2009 and Amendment 1:2014. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) alignment with the new relevant collateral standards; b) addition of computer interface and control; c) addition of new technologies in RADIOTHERAPY, including • BEAM GATING, and • ADAPTIVE RADIOTHERAPY. LIEC 60601-2-1:2020 sapplique a la SECURITE DE BASE et aux PERFORMANCES ESSENTIELLES des ACCELERATEURS DELECTRONS, designes ci-apres sous le terme APPAREILS EM, dans la gamme de 1 MeV a 50 MeV, et utilises pour le TRAITEMENT des PATIENTS. NOTE 1 Meme si les ACCELERATEURS DELECTRONS utilises pour le TRAITEMENT des PATIENTS sont toujours des APPAREILS EM, ils sont parfois designes par le terme APPAREIL DE RADIOTHERAPIE EXTERNE (EBE) dans le present document. Lutilisation du terme EBE ne supprime pas les exigences relatives aux APPAREILS EM; lobjet est de preciser que lAPPAREIL EM examine est lEBE et non un autre APPAREIL EM qui peut faire partie de la configuration du systeme. La presente norme particuliere, associee a des ESSAIS DE TYPE et a des ESSAIS SUR LE SITE, sapplique a la fabrication et a certains aspects de linstallation des ACCELERATEURS DELECTRONS et de leurs appareils utilises pour ameliorer la precision, lexactitude et le ciblage volumetrique pendant la delivrance du TRAITEMENT – qui sont destines a la RADIOTHERAPIE en medecine, y compris ceux dont la selection et lAFFICHAGE des PARAMETRES DE TRAITEMENT peuvent etre controles automatiquement par des SOUS-SYSTEMES ELECTRONIQUES PROGRAMMABLES (SSEP), – qui, en CONDITIONS NORMALES et en UTILISATION NORMALE, fournissent un FAISCEAU DE RAYONNEMENT compose dun RAYONNEMENT X ou dun RAYONNEMENT ELECTRONIQUE dont: • lENERGIE NOMINALE est comprise dans la gamme de 1 MeV a 50 MeV, • les DEBITS DE DOSE ABSORBEE maximaux sont compris entre 0,001 Gy × s–1et 1 Gy × s–1 mesures a lERP de la SOURCE DE RAYONNEMENT, et • les DISTANCES DE TRAITEMENT DE REFERENCE (DTR) sont comprises entre 0,5 m et 2 m de la SOURCE DE RAYONNEMENT; et – qui sont destines a • une UTILISATION NORMALE, sous la responsabilite de lORGANISME RESPONSABLE par des PERSONNES QUALIFIEES dument agreees ou qui ont les competences necessaires pour une utilisation medicale particuliere, pour des applications cliniques SPECIFIEES, • etre entretenus selon les recommandations donnees dans les INSTRUCTIONS DUTILISATION, et • etre verifies periodiquement par une PERSONNE QUALIFIEE selon un programme dASSURANCE QUALITE portant sur le controle des performances et de letalonnage. LIEC 60601-2-1:2020 annule et remplace la troisieme edition parue en 2009 et lAmendement 1:2014. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: a) harmonisation par rapport aux nouvelles normes collaterales pertinentes; b) ajout de linterface et du controle informatiques; c) ajout des nouvelles technologies de RADIOTHERAPIE, notamment • le DECLENCHEMENT DU FAISCEAU, et • la RADIOTHERAPIE ADAPTATIVE.
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