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IEC 61223-3-8 Ed. 1.0 b:2024

Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
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IEC 61223-3-8 Ed. 1.0 b:2024

Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy

PUBLISH DATE 2024
PAGES 204
IEC 61223-3-8 Ed. 1.0 b:2024
Evaluation and routine testing in medical imaging departments - Part 3-8: Acceptance and constancy tests - Imaging performance of X-ray equipment for radiography and radioscopy
IEC 61223-3-8:2024 applies to evaluation of the imaging performance and related quality control parameters of X ray equipment for radiography and radioscopy that conform to IEC 60601-2-54:2022 or IEC 60601-2-43:2022.
This document applies to the evaluation of the imaging performance of the entire imaging chain from image acquisition, image processing and image display.
This document applies to acceptance tests and constancy tests, which are part of the quality assurance program in medical imaging departments and are intended to be performed by or under the responsibility of the responsible organization. A detailed discussion of the position of these tests within the medical radiological equipment lifecycle is provided in Clause A.2. The methods included rely mainly on non-invasive measurements that use appropriate test equipment and are performed after the installation is completed in accordance with the manufacturerÂ’s installation instructions.
IEC 60601-2-54:2022 and IEC 60601-2-43:2022 require information to be provided to the responsible organization with respect to quality control. This document provides guidance to manufacturers regarding the acceptance and constancy tests for the X ray equipment in a manufacturer supplied quality control manual. Annex G provides guidance for such a manual.
SDO IEC: International Electrotechnical Commission
Document Number IEC 61223
Publication Date March 1, 2024
Language b - English & French
Page Count 204
Revision Level 1.0
Supercedes
Committee 62B
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