biocompatibility testing
Required laboratory evaluation of device materials to ensure they do not cause adverse biological reactions when implanted.
Full Definition
Comprehensive laboratory testing performed on cardiac device materials and components to evaluate their safety when in contact with human tissue. Biocompatibility testing follows ISO 10993 standards and includes assessments for cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, and implantation effects. For cardiac devices, this testing is particularly critical given the long-term implantation duration and close contact with blood and cardiac tissue. Results support regulatory submissions and ensure patient safety.
Usage
Usage note: Refer to specific ISO 10993 parts when discussing particular test types.
In Context
- "Biocompatibility testing confirmed the new polymer met all ISO 10993 requirements." — Regulatory submission
- "The biocompatibility testing protocol included both in vitro and in vivo evaluations." — Clinical development plan