Individual skill
extractables-leachables-analyzer
E&L study design and data analysis skill for chemical characterization of medical devices
library/specializations/domains/science/biomedical-engineering/skills/extractables-leachables-analyzer/SKILL.md
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- Last checked
- Nov 9, 2026
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- Repository last updated
- Nov 1, 2026
- License
- MIT
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SKILL.mdcore · 3,162 bytes
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# 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