DANSK DS/EN IEC 62464-1 PDF

This part of IEC 62464 specifies measurement procedures for the determination of many essential image quality parameters for MR EQUIPMENT. Measurement procedures as addressed in this document are suitable for - quality assessment in the ACCEPTANCE TEST, and - quality assurance in the CONSTANCY TEST. Required levels of performance for ACCEPTANCE TESTS are not provided for all tests. This document does not address - image quality assessment of MR EQUIPMENT with a static magnetic field intensity greater than 8 Tesla, if not otherwise stated, - image quality affected by MR-compatibility issues, - special diagnostic procedures such as flow imaging, perfusion, diffusion, radiotherapy and image-guided therapy applications, and - TYPE TESTS. The scope of this document is also limited to measuring image quality characteristics in images acquired on TEST DEVICES, not in PATIENT images. The measurement procedures specified in this document are directed to - MANUFACTURERS, who can demonstrate compliance by performing ACCEPTANCE and CONSTANCY TESTS as described by this document, - test houses, who can confirm performance of MR EQUIPMENT using methods described in this document, - regulatory authorities, who can reference this document, and - RESPONSIBLE ORGANISATIONS who want to perform ACCEPTANCE and CONSTANCY TESTS using methods described in this document. The essential image quality parameters and measurement methodologies defined in this document are - SIGNAL TO NOISE RATIO, - UNIFORMITY, - SLICE THICKNESS in 2-D scanning, - 2-D GEOMETRIC DISTORTION, - SPATIAL RESOLUTION, and - GHOSTING ARTEFACTS. Each of these procedures can be performed standalone or in combination with any of the other procedures. This document describes the preferred measurement procedures. It also describes alternative normative methods in Annex A. The preferred test methods may be substituted with these If necessary, other methods not described in this document can be used, ...