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Updated: Sep 14, 2026

Accessing the Cytotoxicity and Cell Response to Biomaterials
Published on: July 8, 2021
Study of the in vitro cytotoxicity testing of medical devices
Weijia Li1, Jing Zhou1, Yuyin Xu1
1Henan Province Institute for Medical Equipment Testing, Zhengzhou, Henan 450003, P.R. China.
Abstract:
The cytotoxicity test is one of the biological evaluation and screening tests that use tissue cells in vitro to observe the cell growth, reproduction and morphological effects by medical devices. Cytotoxicity is preferred as a pilot project test and an important indicator for toxicity evaluation of medical devices as it is simple, fast, has a high sensitivity and can save animals from toxicity. Three types of cytotoxicity test are stated in the International Organization for Standardization 109993-5: Extract, direct contact and indirect contact tests. The xCELLigence real-time cell analysis system shows a significant potential in regards to cytotoxicity in recent years. The present review provides a brief insight into the in vitro cytotoxicity testing of medical devices.
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