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biocompatibility-test-selector

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Biocompatibility test selection and protocol recommendation skill based on device categorization

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Source SKILL.md: https://github.com/a5c-ai/babysitter/blob/HEAD/library/specializations/domains/science/biomedical-engineering/skills/biocompatibility-test-selector/SKILL.md

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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 methods
  • Test laboratory databases
  • Sample preparation guidelines
  • Control material sources

Configuration

biocompatibility-test-selector:
  test-categories:
    - cytotoxicity
    - sensitization
    - irritation
    - acute-toxicity
    - subchronic-toxicity
    - genotoxicity
    - implantation
    - hemocompatibility
  method-preferences:
    - in-vitro-first
    - validated-alternatives
    - traditional

Output Artifacts

  • Test battery recommendations
  • Protocol specifications
  • Sample requirements
  • Cost estimates
  • Timeline projections
  • Lab capability assessments
  • Control material lists
  • Results interpretation guides

Quality Criteria

  • Tests appropriate for device category
  • Protocols reference current standards
  • Sample quantities adequate
  • Cost estimates realistic
  • Timelines achievable
  • Alternative methods considered