Biocompatibility test selector

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/biocompatibility-test-selector

Babysitter enforces obedience on agentic workforces and enables them to manage extremely complex tasks and workflows through deterministic, hallucination-free self-orchestration

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npx -y skills add a5c-ai/babysitter --skill biocompatibility-test-selector

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Biocompatibility test selection and protocol recommendation skill based on device categorization

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