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Babysitter extractables-leachables-analyzer

E&L study design and data analysis skill for chemical characterization of medical devices

install
source · Clone the upstream repo
git clone https://github.com/a5c-ai/babysitter
Claude Code · Install into ~/.claude/skills/
T=$(mktemp -d) && git clone --depth=1 https://github.com/a5c-ai/babysitter "$T" && mkdir -p ~/.claude/skills && cp -r "$T/library/specializations/domains/science/biomedical-engineering/skills/extractables-leachables-analyzer" ~/.claude/skills/a5c-ai-babysitter-extractables-leachables-analyzer && rm -rf "$T"
manifest: library/specializations/domains/science/biomedical-engineering/skills/extractables-leachables-analyzer/SKILL.md
tags
#extractables-analysis#leachables-study#biocompatibility#chemical-characterization#toxicological-assessment#regulatory-compliance
source content

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