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60601-1 or explain how to simplify implementation of 60601-1
to a particular device type, e.g., cardiac defibrillators (IEC
60601-2-4). In spite of the 60 particular standards, a particular
standard for clinical electroporators currently does not exist.
Therefore, it will be necessary to define additional rules for
manufacturing and safe and efficient use of clinical electroporators as relatively new medical devices in addition to those
defined by ISO and EN/IEC standards.
Considering the general standard for medical devices EN/
IEC 60601-1, key safety factors that have to be considered in
electroporator's design include: voltage and energy limits,
adequate insulation, limitation of leakage currents, electromagnetic compatibility requirements as presented in the
standard EN/IEC 60601-1-2 and consideration of fault operations while maintaining quality, efficiency and smooth
operation of the device. Other standards to be considered
for developing clinical electroporators are: ISO 14971 for risk
analysis, ISO 13485 for quality management system, EN/
IEC 60601-1-6 and ISO 62366 for usability, ISO 62304 and IEC
80002-1 for medical device software, and IEC 62311 in case of a
battery powered clinical electroporator.

Industrial Electroporators
In biotechnology and even more in food processing technology, high-power and high-voltage electroporators are needed
due to the requirement to electroporate large volumes of liquid. In food processing, electroporation is more frequently
termed as pulsed electric field (PEF) treatment used for food
structure modification or liquid food pasteurization. By PEF
treatment, permeabilization of biological cells is achieved,
mass transfer is improved, and therefore an efficient way for
extraction of liquid and valuable substances from cells is enabled. PEF treatment systems are usually composed of a pulse
power generator and a treatment chamber.
Depending on the application, a suitable pulse generator
has to be chosen with adequate parameters for:
◗◗ pulse shape;
◗◗ peak voltage, which is highly dependent on the desired
application;
◗◗ peak current, which is determined by the object and
volume being treated;
◗◗ geometry of the treatment chamber;
◗◗ average power required, depending on the desired
processing capacity (kilograms/h or liters/h).
In terms of power requirements, scale-up from several kW
for laboratory to more than 100 kW for continuous-flow industrial-level processing was achieved. Therefore, regular average
power of contemporary PEF devices ranges between 30 kW
and 400 kW [10]. Commercial PEF treatment applications are
mostly set up in potato (tuber) industry, fruit juice preservation,
and vegetable processing. For juice processing, electroporation
treatment systems with continuous flow have already been established with capacity of 8000 liters/h, whereas for potato
processing capacity ranges up to 50-80 tons/h.
The use of new processes applied in food industry always requires appropriate process control options and set up
April 2020	

of a systematic preventive approach to food safety - Hazard
Analysis Critical Control Point (HACCP). HACCP has seven
principles that need to be followed, stated in the international
standard ISO 22000 FSMS 2011. In the US, the adoption of different technologies in the food processing industry is also
subject to the regulation of the FDA, and in the EU it falls under the Regulation EU 2015/2283 for novel foods. Regarding
safety of the device, protection against electric shock in case
of insulation failure is important when using the device in
wet environments. For this reason, wineries for example, are
equipped with residual current devices that are responsive to
a leakage current of about 30 mA. Furthermore, electromagnetic compatibility according to standards is recommended.
Thus, the pulse circuit has to be shielded with metal housing,
and mains and leads to the control circuity should be protected
against over-voltage [11].

Laboratory Electroporators
For conducting experiments in the laboratory, users can choose
between several commercially available laboratory-based
electroporators. Choosing the right laboratory electroporator
can be crucial for experiments and treatment protocols as some
laboratory electroporators have limited range and control over
pulse parameters.
An important step to be considered during electroporation is to assure pulse measuring and monitoring because only
few electroporators can report and provide accurate measurements. Large variation of load characteristics is another reason
to measure. The electrical properties of the sample between
the electrodes might affect the current delivered (conductivity
versatility). The resistance of the cuvette, for example, can vary
depending on the conductivity of the media which can drastically change the required current.
However, in laboratories where experiments are done, oscilloscopes and current probes are often not readily available.
Therefore, built-in measurement systems should be provided
to be used with laboratory electroporators. The device should
be able to perform self-tests to ensure flawless operation and
detect single faults. Some use "test" pulses which should be
specified and should not affect/change the sample or influence the outcome of the result. Furthermore, the device should
be able to interact with the operator to ensure safe and efficient
treatment and generation of output pulses, which ensure an
effective experiment. The accuracy of measurements should
be specified in advance, and measuring and comparison of
results during experiments should be reported. Periodic calibrations of the device and equipment need to be made as
well as electrode replacement based on predefined intervals.
When single-use electrodes or electroporation cuvettes are
used, safe disposal after the experiment should be provided
due to the chemical reactions that can change the electrical
properties of the electrodes in the next experiment. Recently,
nanosecond electroporators were introduced and are now being used in laboratory setups. Here, measurement protocols
and delivery of the pulses are more challenging. Special attention and more advanced measurement setups are required, as

IEEE Instrumentation & Measurement Magazine	77



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