Abstract
The continuous development of novel plasma sources for therapeutic applications is leading to a growing demand for test protocols that allow a standardized physical characterization and the estimation of biological efficacy. These data are mandatory for estimating the biological performance of a given plasma source, and to serve as a tool that enables a rough comparison of different plasma sources. Additionally, data can be used for the technical improvement of plasma devices, and regarded as a preliminary stage for the licensing of such sources as medical devices. Thus, a DIN SPEC 91315:2014-06 was implemented to characterize plasma sources in terms of their biological performance including risk and safety potential for the therapeutic use of plasma in medicine.
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Hahn, V., Brandenburg, R., von Woedtke, T. (2018). DIN SPEC 91315: A First Attempt to Implement Mandatory Test Protocols for the Characterization of Plasma Medical Devices. In: Metelmann, HR., von Woedtke, T., Weltmann, KD. (eds) Comprehensive Clinical Plasma Medicine. Springer, Cham. https://doi.org/10.1007/978-3-319-67627-2_35
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