Metrological reliability of optical coherence tomography in biomedical applications

Optical coherence tomography (OCT) has been proving to be an efficient diagnostics technique for imaging in vivo tissues, an optical biopsy with important perspectives as a diagnostic tool for quantitative characterization of tissue structures. Despite its established clinical use, there is no international standard to address the specific requirements for basic safety and essential performance of OCT devices for biomedical imaging. The present work studies the parameters necessary for conformity assessment of optoelectronics equipment used in biomedical applications like Laser, Intense Pulsed Light (IPL), and OCT, targeting to identify the potential requirements to be considered in the case of a future development of a particular standard for OCT equipment. In addition to some of the particular requirements standards for laser and IPL, also applicable for metrological reliability analysis of OCT equipment, specific parameters for OCT's evaluation have been identified, considering its biomedical application. For each parameter identified, its information on the accompanying documents and/or its measurement has been recommended. Among the parameters for which the measurement requirement was recommended, including the uncertainty evaluation, the following are highlighted: optical radiation output, axial and transverse resolution, pulse duration and interval, and beam divergence