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Babysitter iso10993-evaluator

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

install
source · Clone the upstream repo
git clone https://github.com/a5c-ai/babysitter
Claude Code · Install into ~/.claude/skills/
T=$(mktemp -d) && git clone --depth=1 https://github.com/a5c-ai/babysitter "$T" && mkdir -p ~/.claude/skills && cp -r "$T/library/specializations/domains/science/biomedical-engineering/skills/iso10993-evaluator" ~/.claude/skills/a5c-ai-babysitter-iso10993-evaluator && rm -rf "$T"
manifest: library/specializations/domains/science/biomedical-engineering/skills/iso10993-evaluator/SKILL.md
tags
#biocompatibility#iso-standards#medical-devices#risk-assessment#regulatory-compliance
source content

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