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Content DescriptionIEC 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 manufacturer’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. About IECThe IEC is a global, not-for-profit membership organization, whose work underpins quality infrastructure and international trade in electrical and electronic goods. The IEC facilitates technical innovation, affordable infrastructure development, efficient and sustainable energy access, smart urbanization and transportation systems, climate change mitigation, and increases the safety of people and the environment.
The IEC brings together ~170 countries and provides a global, neutral and independent standardization and conformity assessment platform for 30 000 experts globally. It administers 4 Conformity assessment systems whose members certify that devices, systems, installations, services and people work as required.
The IEC publishes around 10 000 IEC International Standards which together with conformity assessment provide the technical framework that allows governments to build national quality infrastructure and companies of all sizes to buy and sell consistently safe and reliable products in most countries of the world. IEC International Standards serve as the basis for risk and quality management and are used in testing and certification to verify that manufacturer promises are kept. |
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