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Standards Development
This standard describes the performance metrics associated with dual-energy capable digital X-ray imaging devices meant for medical applications and specifies the methods for their determination. These metrics analyse tissue-subtracted images to evaluate dose performance, noise characteristics, resolution, susceptibility to object motion, and tissue-subtraction efficacy. The described methods indicate the procedures to obtain dual-energy images and to compute their derived tissue-subtracted images.
The intended users of this part of IEC 62220 are manufacturers and well-equipped test laboratories. This standard is restricted to DIGITAL X-RAY IMAGING DEVICES that are used for single or multiple exposure dual-energy radiographic imaging based on, for example, CR systems, direct and indirect flat panel-detector based systems. This standard is not applicable to:
– DIGITAL X-RAY IMAGING DEVICES intended to be used in mammography or in dental radiography;
– slot scanning DIGITAL X-RAY IMAGING DEVICES;
– COMPUTED TOMOGRAPHY.
– devices for dynamic imaging (where series of images are acquired, as in fluoroscopy or cardiac imaging).
Market offerings of dual-energy capable radiography detectors have now been available for over four decades and are well-known to provide clinical benefits. The first dual-energy X-ray device was commercialized in the 1980s and used a stacked computed-radiography plates approach. The digitalization of X-ray detectors allowed for the introduction of a kVp switching system in the early 2000s. More recently, advances in the field of dual-energy imaging as well as a reduction in component cost have allowed more equipment manufacturers to enter this market, supporting a wider spread adoption of dual-energy radiography. This technology’s potential to offer a lower cost, lower radiation alternative to computed tomography in certain applications has contributed to significant market traction gains.
There is therefore an industrial and regulatory need for a standard metric and method to evaluate the quality of the tissue-subtracted images that different dual-energy devices produce. This is especially true given that the large number of different technological approaches – including traditional kVp switching, filter switching, dual-layer and triple-layer single-shot devices, among others – make it difficult to compare different offerings and distinguish high-quality products. Additionally, the qualitative nature of current tissue-subtracted image assessment makes it time and resource consuming for manufacturers to tune and optimize new technologies, which presents a barrier for new companies to enter this market. This standard will support the ability to measure a device’s quality in an objective and reproducible way. It will not only aid in the development of better quality products but will also enable new technological approaches to tissuesubtracted imaging.
A standard quantitative metric for dual-energy X-ray imaging will enable stakeholders to assess the physical image performance and improve efficiencies of dual-energy X-ray detectors. For manufacturers and system integrators, such a metric is valuable as it supports the comparison of different detectors or technologies. It also facilitates targeted and efficient system optimization, and hence contributes to improving the final image quality of products in the market.
Similarly, this metric will support regulators, by providing additional tools to evaluate dual-energy submissions, especially when assessing new technologies. Having objective quality assessment capabilities supports regulators when establishing requirements for tissue-subtracted image quality, ensuring higher quality systems.
Lastly, this standard will also help healthcare institutions develop their imaging protocols. To achieve this, they must be able to ensure a minimum level of image quality and have the ability to objectively compare detectors. A standard metric supports this, as well as the institutions’ ability to interpret results of external clinical studies and aid in the development of their own internal protocols.
This standard is recommended as an addition to the IEC 62220 Medical electrical equipment - Characteristics of digital X-ray imaging devices standard series, since dual-energy X-ray devices require digital X-ray imaging devices, and the contents of the standard will very closely align with those of IEC 62220-1-1 through 62220-1-3.
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