IEC 61223-3-6-ed.1.0

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Bezeichnung: IEC 61223-3-6-ed.1.0

Ausgabedatum: 07.02.2020

Seiten: 0

Land: Internationale technische Norm

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Annotation

IEC 61223-3-6:2020 applies to the performance of MAMMOGRAPHIC X-RAY EQUIPMENT when used in MAMMOGRAPHIC TOMOSYNTHESIS modes of operation, with respect to image quality and dose. Excluded from the scope of this document are: - MAMMOGRAPHIC X-RAY EQUIPMENT modes of operation other than MAMMOGRAPHIC TOMOSYNTHESIS; - 2D images synthesised from the tomosynthesis images; - reconstructive TOMOGRAPHY other than MAMMOGRAPHIC TOMOSYNTHESIS; - CT SCANNERS covered by IEC 61223-3-5. IEC 61223-3-6:2020 defines a) the essential parameters which describe the acceptability criteria of MAMMOGRAPHIC TOMOSYNTHESIS modes of operation of MAMMOGRAPHIC X-RAY EQUIPMENT with regard to image quality and dose, b) the methods of testing whether measured quantities related to those parameters comply with specified tolerances, and c) CONSTANCY TEST frequency when required. This document is intended to be applied along with the acceptability criteria included in IEC 61223-3-2 or equivalent protocol for 2D mammography which are also relevant for MAMMOGRAPHIC TOMOSYNTHESIS modes of operation. These methods mainly rely on non-invasive measurements that use appropriate test equipment and are performed during or after the installation. Signed statements covering steps in the installation procedure can be used as part of the ACCEPTANCE TEST. Tests required by a higher level of compliance take precedence over similar tests with a lower level of compliance. When the results of the ACCEPTANCE TEST are in compliance with the expected values, the BASELINE VALUES for the subsequent CONSTANCY TESTS are established. LIEC 61223-3-6:2020 sapplique aux performances des APPAREILS DE MAMMOGRAPHIE A RAYONNEMENT X utilises en mode TOMOSYNTHESE EN MAMMOGRAPHIE, en matiere de qualite dimage et de dose. Sont exclus du domaine dapplication du present document: - les modes de fonctionnement des APPAREILS DE MAMMOGRAPHIE A RAYONNEMENT X autres que la TOMOSYNTHESE EN MAMMOGRAPHIE; - les images 2D synthetisees a partir dimages de tomosynthese; - la TOMOGRAPHIE reconstructrice autre que la TOMOSYNTHESE EN MAMMOGRAPHIE; - les TOMODENSITOMETRES couverts par lIEC 61223-3-5. LIEC 61223-3-6:2020 definit: a) les parametres essentiels qui decrivent les criteres dacceptabilite des modes TOMOSYNTHESE EN MAMMOGRAPHIE des APPAREILS DE MAMMOGRAPHIE A RAYONNEMENT X en matiere de qualite dimage et de dose; b) les methodes dessai visant a determiner si les grandeurs mesurees liees a ces parametres sont conformes aux tolerances specifiees; et c) la frequence dESSAI DE CONSTANCE, le cas echeant. Le present document est destine a sappliquer avec les criteres dacceptabilite inclus dans lIEC 61223-3-2 ou un protocole de mammographie 2D equivalent, lesquels sappliquent egalement aux modes TOMOSYNTHESE EN MAMMOGRAPHIE. Ces methodes reposent principalement sur des mesures non invasives, executees pendant ou apres linstallation, en utilisant des equipements dessai appropries. Des declarations signees couvrant des etapes de la procedure dinstallation peuvent etre utilisees dans le cadre de lESSAI DACCEPTATION. Les essais exiges par un niveau de conformite plus eleve prevalent sur les essais similaires associes a un niveau de conformite plus faible. Lorsque les resultats de lESSAI DACCEPTATION sont conformes aux valeurs attendues, les VALEURS DE BASE des ESSAIS DE CONSTANCE ulterieurs sont etablies.