ISO 10993 Package

ISO 10993 Package: Biocompatibility of Medical Devices, particularly

• ISO 10993-3 Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• ISO 10993-5 Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10 Part 10: Tests for skin sensitization
• ISO 10993-23 Part 23: Tests for irritation

Summary

ISO 10993 offers comprehensive guidance and standard methods on the evaluation of biocompatibility for medical devices.  It covers a range of topics related to toxicity assessment for medical device products, including risk assessment, chemical composition, degradation, topical toxicity, cytotoxicity, genotoxicity and systemic toxicity, etc.

Typical Test Substances

• Medical devices, categorized by type of contact with humans and duration of contact

• Non-contacting medical devices (e.g., in-vitro diagnostics devices, etc.)
• Surface-contacting devices (e.g., catheters, contact lenses, etc.)
• Externally communicating devices (e.g., dialyzers, transfusion sets, etc.)
• Implantable devices (e.g., pacemakers, heart valves, etc.)

• Limited exposure – cumulative contact up to 24 hours
• Prolonged exposure – cumulative contact between 24 hours and 30 days
• Long-term exposure – cumulative contact exceeding 30 days

Regulatory Agencies / Purpose

• U.S. Food and Drug Administration (FDA)
• International agencies 

Similar Methods

• OECD toxicity testing methods