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