Process safety and health integrity for you as our valued customer and / or user of our plasma sources is guaranteed by our compliance of the five security features:
No current flow through skin
We use so-called "indirect plasma sources" in which the patient does not act as a counter electrode and consequently there is no current flow through the patient.
Within the world’s first and largest clinical trial with cold plasma (over a period of eight years) terraplasma’s technology was tested and found to be safe for application. New plasma sources are scaled and tested according to the gained clinical data.
The concentration of produced trace gases such as O3, NO or NO2 must be below the statutory legal limits.
Low UV radiation
The design of plasma sources must aim to only produce a minimum of UV radiation (especially UV-C and UV-B). Limits for intact human skin must not be exceeded.
Cell and tissue research
Before cold plasma equipment is authorized for application, research on eukaryotic cells and tissue must be carried out in vitro and ex vivo. These tests include vitality, toxicity and mutagenicity analyses as well as investigations to ensure exclusion of the induction of histological changes and DNA damage.
Micro Plasma Technology
All our studies were based on our micro discharge technology and proved that micro-discharge plasmas can be designed for safe application on patients.
The world's largest clinical trial carried out by the Max Planck Institute for Extraterrestrial Physics, the public hospital Klinikum München, the University Hospital of Regensburg and terraplasma GmbH also verified that cold plasma - produced with the MicroPlaSter, an argon plasma based on microwave technology – can be applied safely on patients.
The study of chronic and acute wounds and Herpes Zoster with a total of 379 patients conducted over 8 years yielded the following results:
• no side effects
• no allergic reactions
• no induction of pain during treatment
In order to implement the results of this clinical trial into other cold plasma devices, detailed scaling of the plasma properties and the in vitro and ex vivo studies have to be performed.