Open Access
28 October 2013 Substantiation of medical and technical requirements for noninvasive spectrophotometric diagnostic devices
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Abstract
A scientific approach to the formulation of medical and technical requirements (MTRs) for noninvasive spectrophotometric diagnostic devices using optical technologies such as laser Doppler flowmetry and absorption spectroscopy is proposed. The theoretical modeling framework, metrological certification, and testing of these devices are still in the early stages of development. The theoretical estimation of the received signal levels for wavelengths between 514 and 940 nm is highly dependent on the blood volume level in the subject tissue. The proposed approach allows, in particular, the calculation of technical and metrological performance constraints of the instruments, such as the ranges of the sensitivity and power-related signal-to-noise ratios for different spectral channels and different biomedical (biochemical and physiological) parameters. Substantiation of specialized MTRs for the noninvasive spectrophotometric diagnostic devices can enable them to develop to the level of standardized measurement techniques.
© 2013 Society of Photo-Optical Instrumentation Engineers (SPIE) 0091-3286/2013/$25.00 © 2013 SPIE
Andrey V. Dunaev, Evgeny A. Zherebtsov, Dimitrii A. Rogatkin, Neil A. Stewart, Sergei G. Sokolovski, and Edik U. Rafailov "Substantiation of medical and technical requirements for noninvasive spectrophotometric diagnostic devices," Journal of Biomedical Optics 18(10), 107009 (28 October 2013). https://doi.org/10.1117/1.JBO.18.10.107009
Published: 28 October 2013
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Cited by 30 scholarly publications.
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KEYWORDS
Blood

Diagnostics

Tissues

Tissue optics

Absorption

Biomedical optics

Signal to noise ratio

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