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.

中文翻译：

---

实现电穿孔设备和协议的标准化

细胞暴露于高电压、短持续时间的电脉冲会导致在质膜中暂时形成亲水性孔并增加膜的渗透性，从而增加分子的跨膜转运，否则这些分子无法穿过膜。这种现象被称为膜电穿孔，目前在生物医学、生物技术、食品技术和环境应用等不同领域是一种适用的技术。电穿孔脉冲由称为电穿孔器的脉冲功率发生器产生，并通过电极传递到细胞（组织中）。本文的目的是回顾和比较文献中描述的和/或市场上存在的电穿孔应用和设备的特性。由于没有具体的标准或法规专门涉及具有预期医疗用途的医疗器械的安全性，我们提出了临床电穿孔仪的设计指南，并定义了其安全和有效使用的最低要求，这些要求可以纳入特定的未来的标准。为了便于比较不同研究组获得的数据并在相同条件下重现结果，我们想强调定义电穿孔器的输出参数和基于电穿孔疗法的电穿孔参数公差的必要性。我们为临床电穿孔器的设计提出了指导方针，并为其安全和有效使用定义了最低要求，这些要求可以在未来纳入特定标准。为了便于比较不同研究组获得的数据并在相同条件下重现结果，我们想强调定义电穿孔器的输出参数和基于电穿孔疗法的电穿孔参数公差的必要性。我们为临床电穿孔器的设计提出了指导方针，并为其安全和有效使用定义了最低要求，这些要求可以在未来纳入特定标准。为了便于比较不同研究组获得的数据并在相同条件下重现结果，我们想强调定义电穿孔器的输出参数和基于电穿孔疗法的电穿孔参数公差的必要性。