Safety evaluation studies (in vitro and in vivo) are conducted on a variety of biomaterials, medical devices, and related products to identify the presence of toxins or any other potentially harmful effects. Biocompatibility testing ranges from the initial screening of new materials to product release testing, periodic audit testing, and non-clinical or pre-market safety evaluations to meet current FDA and international standards.
NAMSA performs testing to evaluate biocompatibility appropriate to the intended use of the component material or finished product. These biocompatibility tests challenge various biological models with the test material or a suitable extract. Specific safety programs follow FDA guidance and ISO 10993 standards.
Primary test categories used to determine biological effect include:
- Acute systemic toxicity testing
- Biodegradation testing
- Carcinogenicity testing
- Chronic toxicity testing
- Cytotoxicity testing
- Genotoxicity testing
- Hemocompatibility testing
- Implantation testing
- Intracutaneous irritation testing
- Reproductive/developmental testing
- Sensitization testing
- Subchronic toxicity testing
To view our Biocompatibility test matrix, click here.