DIN SPEC 91315:2024-08 - Draft

This document gives guidelines for the characterization of basic performance parameters of cold atmospheric pressure plasma sources intended for biomedical or biological experiments and for further development into medically applicable plasma sources. The tests cover both physical-technical criteria (including UV irradiance, gas emission, electrical current flow) for plasma sources for biomedical applications, as well as basic criteria for characterizing biological plasma effects (including detection of chemical species and effects on cell cultures, microorganisms and tissue samples). This document is intended for test laboratories and manufacturers of therapeutic cold atmospheric pressure plasma sources that are classified as ME devices or ME systems in accordance with IEC 60601-1. This document is also intended for research institutions working in the field of research, design and development of therapeutic cold atmospheric pressure plasma sources. This DIN SPEC has been developed according to the PAS procedure. The development of a DIN SPEC according to the PAS procedure is carried out in DIN-SPEC-consortiums and does not require the participation of all stakeholders.