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iso10993-evaluator

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Biological evaluation planning skill implementing ISO 10993-1 for biocompatibility testing strategy

library/specializations/domains/science/biomedical-engineering/skills/iso10993-evaluator/SKILL.md

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# ISO 10993 Evaluator Skill

## Purpose

The ISO 10993 Evaluator Skill supports biological evaluation planning per ISO 10993-1, determining biocompatibility testing requirements based on device categorization, contact type, and duration.

## Capabilities

- Device categorization (body contact, duration)
- Testing endpoint determination matrix
- Existing data evaluation guidance
- Equivalence assessment templates
- Gap analysis for testing requirements
- Biological evaluation plan generation
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