Medical Devices

Today the medical device industry is highly regulated and standard biological safety assessments (ISO 10993) are required for products to be manufactured.

Intox offers biocompatibility and chemical characterization (ISO 10993) testing for medical devices.

Biocompatibility studies

• Cytotoxicity (ISO10993, Part 5)
• Sensitization (ISO10993, Part 10)
• Intracutaneous test (ISO10993, Part 10)
• Implantation studies (ISO10993, Part 6)
• Hemocompatibility (ISO10993, Part 4)
• Genetic toxicology (ISO10993, Parts 3 and 33)
• Systemic toxicity studies (ISO10993, Part 11)
  • Acute
  • Chronic
  • Developmental & reproduction
  • Carcinogenicity
• Pyrogen (ISO10993, Part 11)

Chemical characterization

• Chemical characterization (ISO10993, Part 18)
• E&L studies with risk assessment (ISO10993, Parts 17 and 18)