How do I install the Iso10993 Evaluator skill?

Run npx skillmds@latest add a5c-ai/iso10993-evaluator in your terminal (requires Node.js), paste this page's agent-chat prompt into Claude, Cursor, or any MCP-connected agent, or download the SKILL.md file and copy it into your agent's skills directory.

Is Iso10993 Evaluator safe to use?

This skill has not completed SkillMD's automated safety review yet. Independent scanners report: SkillSpector: PASS, Skill Scanner: PASS. Capability flags: docs only. SkillMD never runs a skill's scripts for you; review the SKILL.md before installing.

Which AI agents work with Iso10993 Evaluator?

This skill is tagged as working with Claude Code, Claude.ai, OpenAI Codex. SKILL.md is an open format, so most agents that read a skills directory can load it too.

Is Iso10993 Evaluator free to use?

Yes. Installing skills from SkillMD is free, and the skill stays under its author's original license.

Who published Iso10993 Evaluator?

a5c-ai (@a5c-ai) published this skill. Their other Agent Skills are listed on their SkillMD profile.

Iso10993 Evaluator by a5c-ai — Agent Skill

Name: Iso10993 Evaluator
Rating: 4.2 (5 reviews)
Author: a5c-ai

File contents

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

---name: iso10993-evaluatordescription: Biological evaluation planning skill implementing ISO 10993-1 for biocompatibility testing strategy--- # 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 ```yaml 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

Frequently asked questions

Iso10993 Evaluator