Introduction to DIN-specification 91315 based on the characterization of the plasma jet kINPen® MED

Standardization is an important tool to reduce costs and risks of research. For the innovative field of plasma medicine, no national or international standards could be identified until now. The present study introduces the first German DIN (German Institute of Standardization)-specification 91315 named “General requirements for medical plasma sources” which was published in June 2014. This developable specification describes obligatory basic criteria for the characterization of different biocompatible cold atmospheric pressure plasma (CAP) sources which are intended supposed for medical applications. With these test methods it is possible to obtain information about performance characteristics as well as effectiveness and safety of medical plasma sources. The suggested biological and physical test methods have been carried out with the CAP jet kINPen® MED. We demonstrate that both test methods described in the DIN-SPEC 91315 are easily to adapt and that the plasma device kINPen® MED is safe and effective with regard to its physical and biological requirements.