IEC 61223-3-7-ed.1.0

Detail information

Designation: IEC 61223-3-7-ed.1.0

Publication date: 07/12/2021

Pages: 83

Country: International technical standard

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Anotation

IEC 61223-3-7:2021 applies to DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT, hereafter also called DENTAL CBCT EQUIPMENT, that conforms to IEC 60601-2-63:2012 and IEC 60601-2-63:2012/AMD1:2017. This document applies to ACCEPTANCE TESTS and CONSTANCY TESTS on DENTAL CONE-BEAM COMPUTED TOMOGRAPHY X-RAY EQUIPMENT. The aim of ACCEPTANCE TESTS is to verify compliance of the installation or MAJOR SERVICE ACTION with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. The requirements specified in this document are minimal requirements. The MANUFACTURER can establish criteria for the tests described here that exceed the levels contained in this document. CONSTANCY TESTS are performed to ensure that the functional performance of ME EQUIPMENT meets established criteria and to enable the early recognition of changes in the properties of components of the ME EQUIPMENT, and to verify compliance with specifications affecting the image quality, RADIATION OUTPUT and PATIENT positioning. This document also contains requirements for the ACCOMPANYING DOCUMENTS associated with ACCEPTANCE AND CONSTANCY TESTING of the DENTAL CBCT EQUIPMENT. This document does not apply to: - aspects of thermal, EMD (electromagnetic disturbances), mechanical and electrical safety; - aspects of mechanical, electrical and software performance, unless they are essential for performing the ACCEPTANCE TESTS and CONSTANCY TESTS, and directly affect image quality, RADIATION OUTPUT and PATIENT positioning. Equipment in the scope of IEC 61223-3-5 is excluded from the scope of this document. DENTAL EXTRA-ORAL X-RAY EQUIPMENT can provide modalities which are in the scope of IEC 61223-3-4. In this case, the respective clauses of the IEC 61223-3-4 apply. The object of this document is to establish: - the essential parameters which describe the performance of DENTAL CBCT EQUIPMENT with regard to the image quality, RADIATION OUTPUT and PATIENT positioning; - methods of testing and whether measured quantities related to those parameters comply with the specified requirements. These methods rely on non-invasive measurements performed once the installation or a MAJOR SERVICE ACTION is completed. LIEC 61223-3-7:2021 sapplique aux APPAREILS A RAYONNEMENT X DENTAIRES a TOMODENSITOMETRIE A FAISCEAU CONIQUE, ci-apres egalement appeles APPAREILS CBCT DENTAIRES, qui sont conformes a IEC 60601-2-63:2012+AMD1:2017+AMD2:2021. Le present document sapplique aux ESSAIS DE RECEPTION et aux ESSAIS DE CONSTANCE des APPAREILS A RAYONNEMENT X DENTAIRES A TOMODENSITOMETRIE A FAISCEAU CONIQUE. Les ESSAIS DE RECEPTION ont pour objet de verifier la conformite de linstallation ou dune OPERATION DE MAINTENANCE IMPORTANTE aux specifications relatives a la qualite de limage, au RAYONNEMENT DE SORTIE et au positionnement du PATIENT. Les exigences specifiees dans le present document sont des exigences minimales. Dans le cadre des essais decrits ici, le FABRICANT peut etablir des criteres qui depassent les niveaux indiques dans le present document. Les ESSAIS DE CONSTANCE ont pour objet dassurer que les performances fonctionnelles de lAPPAREIL EM satisfassent aux criteres etablis et de permettre lidentification precoce des modifications des proprietes des composants de lAPPAREIL EM, mais egalement de verifier la conformite aux specifications relatives a la qualite de limage, au RAYONNEMENT DE SORTIE et au positionnement du PATIENT. Le present document contient egalement les exigences associees aux DOCUMENTS DACCOMPAGNEMENT lies aux ESSAIS DE RECEPTION ET DE CONSTANCE de lAPPAREIL CBCT DENTAIRE. Le present document ne sapplique pas: – aux aspects concernant la securite thermique, la securite liee aux perturbations electromagnetiques (EMD - electromagnetic disturbances), la securite mecanique et la securite electrique; – aux aspects concernant les performances mecaniques, electriques et logicielles, a moins quils ne soient essentiels a lexecution des ESSAIS DE RECEPTION et des ESSAIS DE CONSTANCE, et quils affectent directement la qualite dimage, le RAYONNEMENT DE SORTIE et le positionnement du PATIENT. NOTE 3 Ces aspects sont en general traites dans l’IEC 60601-1 (toutes les parties). Le materiel relevant du domaine dapplication de lIEC 61223-3-5 est exclu du domaine dapplication du present document. Certaines modalites des APPAREILS A RAYONNEMENT X DENTAIRES EXTRA-ORAUX peuvent relever du domaine dapplication de l’IEC 61223-3-4. Dans ce cas, les articles correspondants de l’IEC 61223-3-4 sappliquent. Le present document a pour objet detablir: – les parametres importants qui decrivent les performances des APPAREILS CBCT DENTAIRES en ce qui concerne la qualite dimage, le RAYONNEMENT DE SORTIE et le positionnement du PATIENT; – les methodes dessai et si les grandeurs mesurees liees a ces parametres sont conformes aux exigences specifiees. Ces methodes sappuient sur des mesurages non invasifs executes a lissue de linstallation ou dune OPERATION DE MAINTENANCE IMPORTANTE.