ReddRadar
Agent skill
extractables-leachables-analyzer
E&L study design and data analysis skill for chemical characterization of medical devices
Install this agent skill to your Project
npx add-skill https://github.com/a5c-ai/babysitter/tree/main/library/specializations/domains/science/biomedical-engineering/skills/extractables-leachables-analyzer
Metadata
Additional technical details for this skill
- domain
- science
- category
- Biocompatibility and Materials
- skill id
- BME-SK-017
- specialization
- biomedical-engineering
SKILL.md
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 Preparation
Dependencies
- Mass spectral databases
- Toxicology databases (ToxNet)
- ISO 10993-18 standard
- ICH Q3D guidelines
- Analytical laboratory capabilities
Configuration
extractables-leachables-analyzer:
extraction-types:
- exhaustive-extraction
- simulated-use
- accelerated
analytical-methods:
- GC-MS
- LC-MS
- ICP-OES
- ICP-MS
- headspace-GC
solvents:
- polar
- semi-polar
- non-polar
Output Artifacts
- E&L study protocols
- Extraction condition specifications
- Analytical method recommendations
- AET calculations
- Compound identification tables
- Toxicological risk assessments
- Chemical characterization reports
- Safety assessment summaries
Quality Criteria
- Extraction conditions appropriate for device use
- Analytical methods detect relevant compounds
- AET properly calculated and applied
- Compound identification well-supported
- Toxicological assessment comprehensive
- Documentation supports regulatory review
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