title: Substantiation of medical and technical requirements for noninvasive spectrophotometric diagnostic devices.
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.
authors.affiliation: University of Dundee, Photonics and Nanoscience Group, School of Engineering, Physics and Mathematics, Dundee DD1 4HN, United KingdombState University-Education-Science-Production Complex, Scientific-Educational Center of Biomedical Engineering, Oryol 302020, Russian Federation.
authors.forename: Andrey V
authors.initials: AV
authors.lastname: Dunaev
authors.forename: Evgeny A
authors.initials: EA
authors.lastname: Zherebtsov
authors.forename: Dmitrii A
authors.initials: DA
authors.lastname: Rogatkin
authors.forename: Neil A
authors.initials: NA
authors.lastname: Stewart
authors.forename: Sergei G
authors.initials: SG
authors.lastname: Sokolovski
authors.forename: Edik U
authors.initials: EU
authors.lastname: Rafailov
mesh_terms: D020405:Dermis / Q000098:blood supply / Q000737:chemistry; D006403:Hematologic Tests; D006801:Humans; D017078:Laser-Doppler Flowmetry / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D061848:Optical Imaging / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D012815:Signal Processing, Computer-Assisted; D059629:Signal-To-Noise Ratio; D013053:Spectrophotometry / Q000295:instrumentation / Q000379:methods / Q000592:standards*