Medical Device Biocompatibility Testing

We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.

Our biocompatibility testing is a fundamental step in allowing a medical device to be recognised as safe for use. All medical devices which encounter human tissue should be subject to biocompatibility testing, critically cytotoxicity evaluation. We offer tests which aid in addressing the biocompatibility of medical device materials. These tests are performed to ISO 10993-5 to determine cytotoxic potential.

To determine which test are relevant to your device, we offer a biological evaluation plan (BEP) which will identify the tests needed for your medical device, as well as sourcing available information on your product. After constructing the BEP and performing the required tests and sourcing the biocompatibility information, Test labs offer a biological evaluation Report (BER) with the complete set of justifications and results on your product.

Medical Device Biocompatibility Testing: Everything You Need to Know

Biocompatibility testing is fundamental in deciphering if a medical device is safe to use when introducing a medical device into t...

ISO 10993-10 Skin Sensitization: Everything You Need to Know

ISO 10993-10 Skin sensitization testing assesses the possible contact of hazards from chemicals which are released from a medical ...

What does ‘Knowledgeable and Experienced Professionals’ mean when choosing your BEP author

ISO 10993 states the evaluation must be performed by knowledgeable & experienced professionals, but is you BEP author is up for th...