Iso10993 evaluator

Skill a5c-ai/babysitter/library/specializations/domains/science/biomedical-engineering/skills/iso10993-evaluator

Biological evaluation planning skill implementing ISO 10993-1 for biocompatibility testing strategyFrom its SKILL.md

Install

npx -y skills add a5c-ai/babysitter --skill iso10993-evaluator

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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
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

What ships with it

Read from the repository

Just SKILL.md. No reference files, no scripts.