Instrumentation & Measurement Magazine 23-2 - 78

those electroporators mainly do not have built-in measurement systems.
All of these problems and requirements could be solved
with implementation of a specific standard for electroporators based on the application. As laboratory electroporators
are not considered to be medical devices, medical device standards do not apply, and therefore, the only solution is to gather
all previously mentioned requirements into one standard and
agreeing on requirements that will be followed by all manufacturers to enable comparability and reproducibility of research
and laboratory results. Additionally, electroporation cuvettes
and electrodes should be standardized with defined tolerances
and materials used.

Recommendations for Further Research
and Standardization
Nowadays, the electroporation industry is growing even
faster than before. Taking into consideration the new technologies, treatment protocols, increased research intensity
and knowledge, we already have well-established protocols,
equipment and promising treatments.
For achieving successful and efficient electroporation, it
is necessary to have well defined output pulses and measure
them in each treatment or experiment to make sure that the
pulses are delivered as requested. Thus, suitable reproduction
and comparison of results can be made if necessary. When delivering electrical pulses for electroporation, regardless of the
application, it is very important to provide complete reports
to enable comparability and reproducibility of the results [4],
[12]-[14].
A description of pulses and how the electrical pulses were
measured is necessary. The researchers must provide all specifications of the measuring equipment, identify the point
of measurement and state if the pulses were delivered and
measured in each experiment. Additionally, parameters and
complete time-domain waveforms of the pulses should be
provided with an appropriate description of the electroporator and electrodes used. For commercial equipment, the name
of the company and model should be specified. If the pulse
generator is a laboratory prototype or specially manufactured
unit, suitable description of the components, electrical configuration, measurement and data acquisition systems should
be provided. Lastly, the electric field induced by the delivered
pulses inside the biological load should be calculated and/
or all data describing the electric field should be listed i.e.,
electrode shape and their position with respect to the treated
sample/tissue.
Currently, we can say that we have a developing market
for clinical electroporators and new electroporators designed
for specific applications are coming up. However, the absence of industry, laboratory and medical specific standards
may eventually become an obstacle for further development of approved electroporation devices and associated
equipment. Papers calling for standardization for other applications of electroporation have already been published
(e.g., for standardization of IRE techniques and protocols),
78	

in which authors propose a set of technical recommendations for the use of IRE for treatment of locally advanced
pancreatic cancer [15]. Having a specific standard for each
application will simplify the harmonization of all commercial, certified electroporators and improve the safety, quality
and efficiency of these devices. Current problems like voltage drop during pulse delivery, unknown pulse parameters,
insufficient electrical field, and non-comprehensive reports
can be solved by stating limits and recommendations for
voltage/current, energy, load, electrodes used, insulation
and design.
The standard should define:
◗◗ maximum tolerances of generated pulses compared to
expected values by considering the plasma membrane
permeabilization of the load and technical limitations of
electroporation device development;
◗◗ how to provide technical specifications of the device,
together with conditions under which they are achieved,
e.g., to define maximum amplitude of the pulses together
with the pulse duration range and load resistance at
which it can be achieved;
◗◗ pre-pulses (amplitude, pulse duration and exact timing
regarding the preset sequence), if used;
◗◗ how to implement safety features like galvanic isolation, current, energy and voltage limitations, warnings if
the pulse delivery was stopped or limited, or if any other
unforeseeable event or malfunction has occurred;
◗◗ by which load the electroporators should be tested to
ensure effectiveness at specific applications, or to ensure
predictable operation or operation within tolerances (this
can be quite challenging in case of delivery of nanosecond
pulses as pulse reflections can occur due to the dynamics and variability of the biological load, i.e., conductivity
increase due to electroporation);
◗◗ which electroporation cuvettes and electrodes should be
used;
◗◗ maximum tolerances of the distances between the
electrodes.
The standard should also consider procedures for different
materials used and recommend a way of defining a treatment volume and an electric field distribution between the
electrodes.

Recommendation for Electrochemotherapy
Device Standardization
ECT is an established cancer treatment used in clinics [16] for
safe and convenient treatment of cutaneous and subcutaneous tumors following standard operating procedure (SOP)
[17], [18]. The pulses are delivered to target tissue via electrodes, which are considered to be medical accessories, used
only in combination with a particular pulse generator (mostly
used is the Cliniporator EPS02). If the electrodes are placed on
the patient's skin (e.g., plate or non-penetrate electrodes), they
are considered to be non-invasive medical accessories, used
to treat cutaneous tissues. In cases when they are intended to
be placed inside the patient's body (e.g., needle electrodes),

IEEE Instrumentation & Measurement Magazine	

April 2020



Instrumentation & Measurement Magazine 23-2

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