In Vivo Testing

In vivo tests; The biological response of the medical device in the tissue or body fluid it comes into contact with, depending on the contact time, is evaluated as local, systemic and mutagenic. After the in vitro tests are completed, the tests determined in the matrix are performed depending on the intended use and duration of the device.

The In Vivo test series has a wide range from irritation/sensitization tests to implantation or toxicity tests. Test times vary between 2 weeks and 6 months. Specifically, carcinogenicity testing is carried out for up to 2 years or for the lifetime of the animal.

SENSITIZATION TEST – EN ISO 10993-10 Does your medical device cause skin sensitivity?
IRRITATION TEST - EN ISO 10993-23 Are there potential irritants in your medical device?
HEMOLYTIC EFFECT EN ISO 10993-4 Is your medical device in contact with blood?
GENOTOXICITY – EN ISO 10993-3 Does your medical device cause genetic damage? Does it damage DNA?
IMPLANTASTON TEST – EN ISO 10993-6 Do you have an implantable device or a device that directly contacts living tissue?
PYROGENITY TEST – EN ISO 10993-11 Do you know the degree of pyrogenic contamination of your medical devices?