Instrumentation & Measurement Magazine 23-2 - 76

Fig. 2. Block diagram of an electroporator. An electroporator comprises a user interface, to enable setting of the pulse; a control unit; a high-voltage (HV) power
supply and pulse generator for generation and forming of electrical pulses; an output module, and in case of multiple electrodes, a commutator for switching the
voltage pulses to different electrodes. Measuring of the delivered pulses is preferable and warnings in case of malfunction and/or incorrect operation should be
generated.

applications, pulses with specifically predefined parameters
have to be used. Therefore, electroporators are often designed
and developed for specific applications, where quality and efficiency have to be assured [8].

Clinical Electroporators
Electroporation-based medical/clinical applications such
as ECT, GET, IRE and PFA, have so far been focused predominantly on cancer treatments. Electroporators used for
medical treatments in clinics, i.e., clinical electroporators,
have been developed to implement antitumor therapy using
a limited number of predefined settings of electrical pulses in
associations with chemotherapeutic drugs (ECT) or foreign
substances such as DNA (GET) within protocols based on reversible electroporation or as stand-alone ablation treatment
based on irreversible electroporation (IRE). The target tissue
(e.g., tumor) should be covered with sufficiently high electric
field, which should be above the threshold of reversible or irreversible electroporation 500-600 V/cm local electric field
(which often requires pulse amplitudes up to 3000 V and currents up to 50 A), to achieve the desired effect. Therefore, HV
pulse generators are needed which should not present potential risk for hazardous event for the patient, operator and
nearby devices.
Clinical electroporators are considered to be medical devices, and thus, patient and operator safety must be ensured
under both normal and single-fault conditions. Furthermore,
they are obligated to meet medical device standards and follow the requirements defined by local medical regulations
(e.g., Medical Device Regulation 2017/745 in Europe or Code
of Federal Regulations Title 21 in the US) in order to get approval for selling the device on the market, (e.g., certification
mark (CE) in Europe or Food and Drug Administration (FDA)
approval in the US). In spite of agreements signed between the
EU and the US, a clinical electroporator approved for use in
Europe cannot be automatically used in the US and vice versa,
because each country has different regulatory regimes.
76	

Based on our review, there are only few certified clinical
electroporators on the market. The most used clinical electroporators are the Cliniporator and the NanoKnife System. In
Europe, the Cliniporator (two different models: Cliniporator
EPS02 and Cliniporator VITAE), manufactured by IGEA S.p.A.
(Carpi MO, Italy) and used for both ECT and GET, was approved by the Italian notified body and has CE mark. Another
certified clinical electroporator in Europe is SENNEX (BionMed Technologies, Germany), which is used only for ECT.
Recently, a new CE approved clinical electroporation generator ePORE (Mirai Medical, Galway, Ireland) was developed
for simple and reliable delivery of ultra-short electrical pulses
up to 250 kHz to enable treatment on an outpatient endoscopy
basis. On the other hand, in the US, the NanoKnife System,
manufactured by AngioDynamics, Inc. (Queensbury, NY),
was approved by the FDA for surgical ablation of soft tissue
[9]. Additionally, it is CE marked for Europe and has license
approval for Canada for soft tissue ablation. However, it does
not have FDA clearance for other treatments and therapies for
specific disease or condition.
To help verify the safety of medical devices, electrical
safety standards have been established in the US, Europe and
other parts of the world. The first medical standard for medical electrical equipment IEC 60601 was published in 1977 by
the International Electrotechnical Commission (IEC), which is
a family of technical standards whose scope covers the safety,
essential performance and electromagnetic compatibility of
medical electrical equipment and systems. As of 2011 it consists
of a general standard for medical electrical equipment: 60601-1
(EN 60601-1:2006/A1:2013 in EU or IEC 60601-1:2005/A1:2012
in the US), ten collateral standards and about 60 particular
standards. Collateral standards (numbered 60601-1-X) define
the general requirements for certain aspects of safety and performance, e.g., Electromagnetic Compatibility (IEC 60601-1-2).
Particular standards (numbered 60601-2-X) define particular
requirements for specific products or specific measurements
built into products and add conditions not mentioned in

IEEE Instrumentation & Measurement Magazine	

April 2020



Instrumentation & Measurement Magazine 23-2

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