DIN EN IEC 63483:2025-09
Methods for spectral imaging performance evaluation of computed tomography (IEC/CDV 63483:2025); German and English version prEN IEC 63483:2025 / Note: Date of issue 2025-08-22
| Fecha edición: |
2025-09-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document applies to spectral image types based on data provided by a CT scanner that confirms to IEC 60601-2-44 . The spectral images can be generated either on the CT scanner or with separate software. The purpose of this standard is to provide selected methods and metrics for evaluation of imaging performance associated with the following spectral image type (if available): - Conventional image; Virtual monoenergetic image; Virtual non contrast image; Iodine concentration imag; Electron density image. NOTE?The methods presented in this document do not provide comprehensive technical performance evaluation of CT spectral imaging. The results obtained using the methods of this document do not replace CT spectral imaging performance specifications and testing protocols as provided by manufacturer. This standard does neither specify performance criteria for acceptance testing or constancy testing nor does it specify requirements for manufacturers to provide such criteria. However, manufacturers may provide performance data and/or quality assurance test criteria according to the methods described in this standard. Additionally, phantom requirements are specified accordingly. Spectral image types not listed above are not covered by this document, as explained in Annex D. |
| Keywords: | Computed tomography|Definitions|Diagnostic equipment|Imaging|Instructions for use|Irradiation apparatus|Medical equipment|Medical radiology|Medical technology|Methods|Operational instructions|Performance record|Radiology apparatus (medical)|Spectral|Spectroradiometry|Wear-quantity |
| ICS: | 35.240.80 - Aplicaciones de las tecnologías de la información en la sanidad, 11.040.50 - Equipo radiográfico |
| CTN: | |
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Equivalencia Internacional |
Idéntica prEN IEC 63483:2025 |
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