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IEC 62083-ed.3.0
Medical device software - Requirements for the safety of radiotherapy treatment planning systems
Translate name
STANDARD published on 9.12.2025
The information about the standard:
Designation standards: IEC 62083-ed.3.0
Publication date standards: 9.12.2025
SKU: NS-1252502
The number of pages: 120
Approximate weight : 391 g (0.86 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 62083-ed.3.0 :
IEC 62083:2025, with the inclusion of type tests and site tests, applies to the design, manufacture, installation, and maintenance of the radiotherapy treatment planning system. This document applies to the communication of the radiotherapy treatment planning system with other devices – used in medical practice, – that imports data either through input by the operator or from other devices, – that outputs data to other devices, and – that is intended to be - for normal use, under the authority of appropriately qualified persons, by operators having the required skills and training, - used and maintained in accordance with the recommendations given in the instructions for use, and – used within the environmental conditions specified in the technical description. This document applies to any software application that is used for the development, evaluation, or approval of a treatment plan, whether stand-alone or part of another system. IEC 62083:2025 cancels and replaces the second edition published in 2009. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: – modification of the title from Medical electrical system - Requirements for the safety of radiotherapy treatment planning systems, to Medical device software - Requirements for the safety of radiotherapy treatment planning systems; – Adaptive radiotherapy is added with Clause 16; – The title reflects different implementations of radiotherapy treatment planning systems. LIEC 62083:2025, avec linclusion des essais de type et des essais sur le site, sapplique a la conception, a la fabrication, a linstallation et a la maintenance du systeme de planification de traitement en radiotherapie. Le present document sapplique a la communication du systeme de planification de traitement en radiotherapie avec dautres dispositifs – utilises dans la pratique medicale, – qui utilisent des donnees entrees par loperateur ou importees depuis dautres dispositifs, – qui produisent des donnees de sortie vers dautres dispositifs, et – qui sont destines a • une utilisation normale, sous la responsabilite de personnes qualifiees de facon appropriee, par des operateurs (3.45) ayant les competences et la formation exigees, • etre utilises et entretenus selon les recommandations donnees dans les instructions dutilisation, et • etre utilises dans les conditions denvironnement specifiees dans la description technique. Le present document sapplique a toute application logicielle utilisee pour le developpement, levaluation ou lapprobation dun plan de traitement, autonome ou qui fait partie dun autre systeme. LIEC 62083:2025 annule et remplace la deuxieme edition parue en 2009. Cette edition constitue une revision technique. Cette edition inclut les modifications techniques majeures suivantes par rapport a ledition precedente: – remplacement du titre Appareils electromedicaux – Exigences de securite pour les systemes de planification de traitement en radiotherapie par Logiciels de dispositifs medicaux – Exigences de securite pour les systemes de planification de traitement en radiotherapie; – ajout de la radiotherapie adaptative a lArticle 16; – le titre reflete differentes mises en ouvre des systemes de planification de traitement en radiotherapie.
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