This time, Alleder's PU Integral Skin Foam armrest product uses the MTT cytotoxicity test according to ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Test to determine the cytotoxicity of the sample extract.

Alleder's PU Integral Skin Foam armrest have passed the SGS In Vitro Cytotoxicity Test. In Vitro Cytotoxicity testing is a critical step in evaluating the safety and effectiveness of medical devices. During the marketing process, In Vitro Cytotoxicity testing can help determine whether a product has toxic effects on cells, thereby ensuring user safety.

What is In Vitro Cytotoxicity Test

In vitro cytotoxicity testing is a crucial step in biocompatibility testing. Without cytotoxicity data, there can be no biocompatibility evaluation. In vitro cytotoxicity testing serves as a gatekeeper in the biocompatibility testing system and is a crucial step in the safety assessment of medical devices or materials.  

In vitro cytotoxicity testing is an in vitro assay used to assess the toxic effects of a material on cells. By culturing cells and exposing them to the test material, cell survival and morphological changes can be observed to determine the material's toxicity. This assay is commonly used to assess the safety of medical devices, biomaterials, and pharmaceuticals.

Importance of In vitro cytotoxicity test

1. Ensure Product Safety

In Vitro Cytotoxicity Testing (ICT) can detect potential toxicity issues in medical device materials early on, preventing harm to patients during clinical use. In Vitro Cytotoxicity Testing ensures that medical device materials do not release harmful substances when in contact with the human body, thereby safeguarding patient health and safety.

2. Compliance with Regulatory Requirements

Regulators around the world have stringent requirements for the marketing of medical devices, and in vitro cytotoxicity testing is an essential component. For example, the US FDA and the EU CE certification both require in vitro cytotoxicity testing. By conducting in vitro cytotoxicity testing, companies can ensure their products meet international standards, enabling smooth entry into global markets.