How is biocompatibility verified for medical-grade silicone tubing?

The standard framework is ISO 10993, which defines a risk-based approach to biological evaluation of medical device materials. The process starts with a material characterization phase, where all chemical constituents are identified and assessed for known toxicity. Based on the nature, duration, and body location of the intended contact, a set of biological tests is determined. For tubing in contact with circulating blood or drug solutions, this typically includes cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and hemolysis testing, among others. Testing is conducted by accredited third-party laboratories, and the results form part of the biological evaluation report submitted to the relevant regulatory authority — NMPA in China, FDA in the US, or a notified body under the EU MDR. The registration certificate or filing acknowledgment issued by the regulator is the formal evidence that the material has been evaluated and accepted for the specific intended use. Ruixiang holds biocompatibility test reports covering eight ISO 10993 test categories and can provide documentation on request.

For product specifications, technical data sheets, or sample requests, contact the Ruixiang team: olivia@dgruixiang.com  |  www.medicalsiliconetube.com