Biocompatibility of medical devices
Safe use of materials
Biocompatibility describes the safe use of a material in the body without causing harmful reactions. This is a crucial criterion for medical devices and implants that remain in the body for long periods of time.
Your Benefits with Normec
Manufacturer-independent validation – compatible with all standard devices and systems
Accredited reliability – validation in compliance with current standards and DAkkS accreditation
Cross-specialty expertise – from dental clinics to hospitals: we understand your needs
Ensuring Compliance with MDR and ISO Standards
According to the MDR, medical devices must not pose a biological risk to patients. DIN EN ISO 17664 also requires that biocompatibility is not compromised by the intended reprocessing process. The aim is to protect the patient: materials used in medical devices must not pose a biological risk, either through their composition or through residues or substances released during reprocessing.
One of the initial tests is in vitro cytotoxicity, which we perform in our accredited testing laboratory. The in vitro cytotoxicity test in accordance with the DIN EN ISO 10993-5 series of standards checks whether substances that could have a cell-damaging effect are released from materials or medical devices.
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Validation of reprocessing instructions for medical device manufacturers
Leading company in this service
Normec Valitech
Falkensee Germany