Biocompatibility test selector

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