| name | iso10993-evaluator |
| description | Biological evaluation planning skill implementing ISO 10993-1 for biocompatibility testing strategy |
| allowed-tools | ["Read","Write","Glob","Grep","Edit","Bash"] |
| metadata | {"specialization":"biomedical-engineering","domain":"science","category":"Biocompatibility and Materials","skill-id":"BME-SK-016"} |
| graph | {"domains":["domain:biomedical-engineering"],"skillAreas":["skill-area:statistical-analysis","skill-area:data-analysis","skill-area:compliance-automation"],"workflows":["workflow:experiment-design","workflow:peer-review-cycle"],"roles":["role:biomedical-engineer","role:lab-technician"]} |
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
- Report template generation
- Risk-based testing strategy
- Alternative testing approaches
- Literature review guidance
- Toxicological risk assessment support
Usage Guidelines
When to Use
- Planning biocompatibility testing programs
- Evaluating existing biocompatibility data
- Assessing material equivalence
- Preparing biological evaluation reports
Prerequisites
- Device materials identified
- Contact type and duration defined
- Manufacturing process documented
- Existing data compiled
Best Practices
- Apply risk-based approach per ISO 10993-1:2018
- Evaluate existing data before new testing
- Consider material equivalence carefully
- Document rationale for testing decisions
Process Integration
This skill integrates with the following processes:
- Biological Evaluation Planning (ISO 10993)
- Extractables and Leachables Analysis
- Biomaterial Selection and Characterization
- 510(k) Premarket Submission Preparation
Dependencies
- ISO 10993 series standards
- FDA G95-1 guidance
- Material databases
- Testing laboratory capabilities
- Toxicological databases
Configuration
iso10993-evaluator:
contact-categories:
- surface-device
- external-communicating
- implant
contact-types:
- skin
- mucosal-membrane
- breached-surface
- blood-path-indirect
- tissue-bone
- blood
duration-categories:
- limited
- prolonged
- permanent
Output Artifacts
- Device categorization documents
- Testing requirement matrices
- Biological evaluation plans
- Gap analysis reports
- Equivalence assessments
- BER templates
- Literature review summaries
- Testing rationale documents
Quality Criteria
- Categorization follows ISO 10993-1:2018
- Testing endpoints appropriate for device
- Existing data properly evaluated
- Equivalence arguments supported
- Gap analysis comprehensive
- Documentation supports regulatory review
