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Fig. 4. a) Electroporation square wave pulse: pulse parameters and tolerances. b) Permeabilization curve (solid line) and cell survival (dashed line) with defined
tolerances [19]. For amplitudes between 90% and 110% of the defined SOP amplitude will still be possible to achieve efficient treatment. With amplitudes values
higher than 110%, cell survival will be increasingly lowered and can lead to IRE while with amplitudes values lower than 90%, the cell permeabilization will
decrease and can lead to inefficient tumor treatment.

◗◗ pulse repetition rate may deviate from SOP pulse repetition rate (for both options) for maximum ±5%.
For successful ECT it is important to keep within these
tolerances, as we calculated them to define the maximum deviations where it is still possible to achieve the desired effect. For
example, higher (more than 110% of the amplitude) or lower
(less than 90%) values of the SOP amplitude can lead to IRE
or insufficient electric field for ECT, respectively. Based on the
permeabilization curves (Fig. 2 from reference [19]), even for
pulses with the lowest or highest defined tolerances (for pulse
amplitude and pulse durations), it will still be possible to stay
on the part of the permeabilization curve where the treatment
will be efficient (Fig. 4b).
ECT devices should work within the tolerances on zero
load and on electronic emulator of ECT load. Operation of the
limitation should be tested by the device on power up and conformity by using electronic emulator of biological load.
All electrodes should be manufactured utilizing a biocompatible material, usually stainless-steel. However,
materials tested by the requirements stated in the ISO 10993
series of standards for biological evaluation of medical devices that come into direct or indirect contact with biological
tissues (parts -1, -5 and -10 are the most important) may be
allowed.
Following the SOP, all electrodes need to be for single use.
We propose the option of using multiple-use electrodes. In this
case, clear instructions for electrode cleaning and maintenance
after every treatment should be provided. Moreover, multipleuse electrode replacement on predefined intervals should be
stated and provided in the instructions for use.
80	

The allowed tolerances for the diameters of the electrodes,
the distances between the electrodes and the length of the needles should also be defined.

Conclusions
With implementation of a specific standard for particular applications, electroporation devices will be safer, treatments
more efficient and results more reproducible, which will allow
faster and more straight-forward progress of electroporation
as well as treatments and therapies based on electroporation.
By implementing a particular medical standard for electrochemotherapy electroporation devices, the standard operating
procedure will be improved which will result in better and
more effective cancer treatment.

References
[1]	 T. Kotnik, L. Rems, M. Tarek, and D. Miklavcˇicˇ, "Membrane
electroporation and electropermeabilization: mechanisms and
models," Annu. Rev. Biophys., vol. 48, no. 1, pp. 63-91, May 2019.
[2]	 D. Miklavcˇicˇ, Ed., Handbook of Electroporation. New York, NY, USA:
Springer International Publishing, 2017.
[3]	 D. Miklavcˇicˇ, B. Mali, B. Kos, R. Heller, and G. Serša,
"Electrochemotherapy: from the drawing board into medical
practice," BioMed. Eng. OnLine, vol. 13, no. 1, p. 29, 2014.
[4]	 A. Sugrue et al., "Irreversible electroporation for catheterbased cardiac ablation: a systematic review of the preclinical
experience," J. Interventional Cardiac Electrophysiology, Jul. 2019.
[5]	 T. Kotnik, W. Frey, M. Sack, S. Haberl Meglicˇ, M. Peterka, and D.
Miklavcˇicˇ, "Electroporation-based applications in biotechnology,"
Trends in Biotechnology, vol. 33, no. 8, pp. 480-488, Aug. 2015.

IEEE Instrumentation & Measurement Magazine	

April 2020



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