naSRPS EN IEC 63483:2025

Methods for spectral imaging performance evaluation of computed tomography

Scope

IEC 60601-2-44:2026 is applicable to spectral image types based on data provided by a CT scanner that conforms to IEC 60601-2-44 . The spectral images can be generated either on the CT scanner or with separate software.
The purpose of this document 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 image;
– 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 the manufacturer.
This document does not specify performance criteria for acceptance testing or constancy testing, nor does it specify requirements for manufacturers to provide such criteria. However, manufacturers can provide performance data, quality assurance test criteria, or both according to the methods described in this document.
Additionally, phantom requirements are specified accordingly.
Spectral image types not listed above are not covered by this document, as explained in Annex D.