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DIN SPEC 91315: A First Attempt to Implement Mandatory Test Protocols for the Characterization of Plasma Medical Devices

  • Veronika Hahn
  • Ronny Brandenburg
  • Thomas von Woedtke
Chapter

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.

Keywords

National and international standard Comparability Antimicrobial kINPen® Med Cold atmospheric plasma (CAP) 

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Copyright information

© Springer International Publishing AG, part of Springer Nature 2018

Authors and Affiliations

  • Veronika Hahn
    • 1
  • Ronny Brandenburg
    • 1
  • Thomas von Woedtke
    • 2
  1. 1.Leibniz Institute for Plasma Science and Technology (INP Greifswald)GreifswaldGermany
  2. 2.Leibniz Institute for Plasma Science and Technology (INP Greifswald) and University Medicine Greifswald, Institute for Hygiene and Environmental MedicineGreifswaldGermany

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