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