extractables-leachables-analyzer

# Extractables and Leachables Analyzer Skill ## Purpose The Extractables and Leachables Analyzer Skill supports E&L study design and data analysis for chemical characterization of medical devices per ISO 10993-18, including extraction study design and toxicological risk assessment. ## Capabilities - Extraction solvent and condition selection - Analytical method recommendations (GC-MS, LC-MS, ICP) - AET (Analytical Evaluation Threshold) calculation - Compound identification assistance - Toxicological risk assessment templates - ICH Q3D elemental impurity guidance - Study protocol generation - Data interpretation support - Safety assessment reporting - Simulated use extraction design - Accelerated extraction studies ## Usage Guidelines ### When to Use - Designing E&L characterization studies - Analyzing E&L data - Conducting toxicological risk assessments - Preparing chemical characterization reports ### Prerequisites - Device materials documented - Contact conditions defined - Analytical capabilities identified - Toxicological resources available ### Best Practices - Use risk-based approach per ISO 10993-18 - Consider worst-case extraction conditions - Calculate AET based on patient exposure - Document compound identification rationale ## Process Integration This skill integrates with the following processes: - Extractables and Leachables Analysis - Biological Evaluation Planning (ISO 10993) - Biomaterial Selection and Characterization - 510(k) Premarket Submission P...