International Organization for Standardization
ISO 10993
International Organization for Standardization
What Is ISO 10993?
ISO 10993 is a series of standards for the biological evaluation of medical devices. It covers testing for cytotoxicity, irritation, sensitization and systemic toxicity. Rekky silicone tubing meets ISO 10993 requirements, providing documented biocompatibility for medical and pharmaceutical applications.
Key Requirements
- Part 5: Tests for in vitro cytotoxicity
- Part 10: Tests for irritation and sensitization
- Part 11: Tests for systemic toxicity
- Part 23: Tests for irritation
- Internationally recognized biocompatibility standard
Applicable Products
All platinum-cured silicone tubing series.
Documentation Available
- Certification test reports
- Declaration of Compliance (DoC)
- Material safety data sheets
- Batch-specific COA on request
Questions about ISO 10993?
Our compliance team can provide detailed documentation and answer technical questions.