Akademik Veri Yönetim Sistemi
Innovation in Medicine Summit-2, Gaziantep, Türkiye, 5 - 07 Mayıs 2017, ss.104
According to the ISO 10993-1 standard, cytotoxicity, irritation and sensitization of surface-contacting medical devices should
be evaluated before marketing. Although there are studies that monitor the toxicity of several marketed medical devices,
there are no studies describing the toxicity of surgical masks.
The aim of this studywas to evaluate thebiocompatibility of eight purchased surgical masks of different brands, investigating
their cytotoxicity and inflammation inducing capacity.
Masks were numbered and classified according to their materials. Extractions of the samples were prepared according to
ISO10993-12. Cytotoxicity was assessed via the MTS cell viability assay and inflammation was monitored by measuring nitrite
levels.
A preliminary study revealed that four of the collected sampleswere not cytotoxic while extracts obtained from the remaining
four samples were capable of killing L929 cells. To investigate in more details the origin of this toxicity, the materials
composing these masks were also evaluated separately. While the exposure to non-woven materials did not involve any
changes in cell survival when compared to the control medium, exposing cells to elastic and sponge materials led to their
death in significant levels. Also, some of these materials were shown to induce inflammation that could be related to the
observed cytotoxicity.
Our studies revealed that the half of the randomly collected masks did not suit the biocompatibility criteria established by
the ISO 10993-1 standard, which is a quite unexpected result.