Contact person
Karin Nydahl
Laboratorieingenjör
Contact Karin
ISO 10993-5 Cytotoxicity Test - in vitro
Cytotoxicity testing is a crucial part of the biological evaluation of medical devices and is a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts cytotoxicity testing according to ISO 10993-5 and is accredited under ISO/IEC 17025 or GLP (Good Laboratory Practice).
Why conduct cytotoxicity tests?
By conducting cytotoxicity testing, you ensure that your medical device meets the necessary regulatory requirements under the Medical Device Regulation (MDR) and international standards such as ISO 10993-5.
The test is crucial for guaranteeing patient safety, ensuring that your product does not have harmful effects on cells when it comes into contact with the body. Additionally, cytotoxicity testing helps minimize risks by identifying and eliminating potentially harmful effects at the cellular level early in the product development process, protecting your company from costly recalls and legal issues.
Which methods do we use?
We conduct cytotoxicity testing according to ISO 10993–5 Annex C, the MTT test. This method is used to measure cell viability, i.e., the ability of cells to survive and function normally after exposure to extracts from a test material.
The MTT test is based on the principle that metabolically active cells can convert MTT, a yellow tetrazolium salt, into a blue-purple formazan crystal. The amount of formazan formed is proportional to the number of viable cells, providing a measure of the material’s cytotoxicity.
If the viability of the extract is reduced to <70% of the blank sample, the test is considered to have cytotoxic potential according to the standard.
We follow GLP
We are accredited under ISO/IEC 17025 and follow GLP (Good Laboratory Practice), ensuring that cytotoxicity tests are conducted in a scientifically valid and regulatory-compliant manner.
Delivery
After completing the MTT test according to ISO 10993-5:2009, you will receive a detailed test report in English. The report includes quantitative data showing cell viability after exposure to the test material, as well as recommendations for further testing or actions if the test material shows signs of cytotoxicity.
More information
At RISE, we are pleased to offer testing services for medical devices according to both ISO 10993-5:2009 and ISO 10993-23:2021.
We also provide services to ensure that your products can be cleaned, disinfected, and sterilized safely and effectively according to ISO 17664-1/2 and ISO 17665:2024.
By combining our services under these standards, we can help ensure that your medical devices are biocompatible, sterile, and suitable for reuse—critical factors for patient safety and the product’s success in the market.
