Towards standardization of electroporation devices and protocols

Cell exposure to high-voltage, short-duration electric pulses can lead to temporary formation of hydrophilic pores in the plasma membrane and an increase in the membrane's permeability which consequently increases the transmembrane transport of molecules that are otherwise unable to cross the membrane. This phenomenon, termed membrane electroporation, is currently an applicable technique in different areas such as biomedicine, biotechnology, food technology and environmental applications. Electroporation pulses are generated by pulse power generators known as electroporators and delivered to the cells (in tissue) via electrodes. The objective of this paper is to review and compare characteristics of electroporation applications and equipment described in the literature and/or present on the market. Since there are no specific standards or regulations that specifically refer to the safety of medical devices with intended medical uses for electroporation, we propose guidelines for the design of clinical electroporators and define minimal requirements for their safe and efficient use which can be incorporated within the particular standards in the future. In order to facilitate the comparison of data obtained by different research groups and to enable reproduction of results under the same conditions, we want to stress the necessity of defining the electroporator's output parameters and tolerances of electroporation parameters for electroporation-based therapies.