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