biocompatibility-test-selector

# Biocompatibility Test Selector Skill ## Purpose The Biocompatibility Test Selector Skill recommends appropriate biocompatibility tests and protocols based on device categorization, supporting biological evaluation planning and test laboratory coordination. ## Capabilities - Test battery recommendation by category - ISO 10993 part selection guidance - Test lab capability assessment - Protocol review checklist - In vitro vs. in vivo decision support - Alternative testing approaches (21st century toxicology) - Cost and timeline estimation - Sample requirement calculation - Control material selection - Test article preparation guidance - Results interpretation support ## Usage Guidelines ### When to Use - Selecting biocompatibility tests - Planning testing programs - Evaluating alternative methods - Coordinating with test laboratories ### Prerequisites - Device categorization completed - Materials characterized - Testing gaps identified - Budget and timeline constraints known ### Best Practices - Prioritize in vitro methods where validated - Consider 3Rs (Replace, Reduce, Refine) - Select appropriate positive/negative controls - Plan for sufficient sample quantities ## Process Integration This skill integrates with the following processes: - Biological Evaluation Planning (ISO 10993) - Biomaterial Selection and Characterization - 510(k) Premarket Submission Preparation - EU MDR Technical Documentation ## Dependencies - ISO 10993 test standards - ICCVAM alternative m...