Summary of the Cytotoxicity Testing
According to the International Organization for Standardization and national standards, in addition to mechanical, physical, and chemical performance tests, medical devices must undergo a series of rigorous tests to determine their safety and biocompatibility before they have contact with the body. This series of experiments before entering a clinical environment include cytotoxicity, sensitization, intradermal irritation, acute systemic toxicity, and other biocompatibility tests to ensure that the product can be used safely and effectively. Cytotoxicity is one of the most important biological evaluation methods, because it has many advantages such as simplicity, fast, and high sensitivity. It is also the pilot project test and important indicator for the toxicity evaluation of medical devices. The International Organization for Standardization 109993-5 stipulates three types of cytotoxicity tests: extracts, direct contact and indirect contact tests. These in vitro testing methods are simple and economical tools that can be effectively used to evaluate new materials and ensure the lot-to-lot acceptability of plastics and polymers used in medical devices.
The Cytotoxicity Testing Provided by Creative BioMart Microbe
As an industry leader, Creative BioMart Microbe provides high-quality cytotoxicity testing for medical devices to customers all over the world. Our researchers can utilize our technology platform to efficiently perform extract, direct and indirect contact tests for you.
Molecular filtration: This method detects cytotoxicity by evaluating the activity of the monolayer succinate dehydrogenase effect by medical devices.
Agar overlay assay: This method is used to evaluate biomedical devices that can leach toxic substances, and can be performed on medical devices or extracts.
This method allows the solid medical devices to directly contact the cultured mammalian cells in vitro.
Also known as the 3-(4,5-dimethyl-2-thiazolyl)- 2,5-diphenyl-2H-tetrazolium bromide (methyl thiazolyl tetrazolium; MTT) assay, which is a colorimetric method for quickly assessing cell proliferation and cytotoxicity to measure cell metabolism or function.
In addition, we also provide UV spectrophotometer assay, cell growth inhibition tests, cell rehabilitation method, cell morphology observation, high pressure liquid chromatography and other methods to supplement cytotoxicity analysis.
Creative BioMart Microbe is a professional and advanced biotechnology company that provides a variety of microbial testing services for medical devices. Our advanced technology platform and well-trained technicians will help customers successfully solve their problems.
If you want to know more about this service, please feel free to contact us by phone or email, or you can consult through our inquiry form. We will ensure to provide you with efficient and high-quality experimental outsourcing services.
