Biocompatibility Testing at IIBAT
At IIBAT, we are accredited to conduct comprehensive biocompatibility testing in compliance with NABL standards. Our state-of-the-art Test Facility ensures that medical devices meet stringent safety requirements, confirming their compatibility with biological systems they may contact in clinical settings.
Purpose of Biocompatibility Testing
The objective of biocompatibility testing is to identify any potential adverse effects that medical devices may cause in humans or animals. This evaluation includes a range of tests, such as chemical characterization, toxicological risk assessments, and biological evaluations. Key assessments focus on cytotoxicity, irritation and sensitization through both in vitro and in vivo methods.
Global Regulatory Compliance
Biocompatibility testing requirements differ across countries, with key regulatory bodies such as the FDA (U.S.), ASTM, EMA (Europe), and in India, the CDSCO (Central Drugs Standard Control Organization), overseeing device testing standards.
Medical Device Testing Services
IIBAT provides the following testing services for medical devices:
1. Chemical Characterization Testing
(a) Extractables & Leachable
(b) Degradation products
(c) Residual ethylene oxide
2. Toxicology Testing (In Vivo)
(a) Short-term and long-term toxicity studies
(b) Irritation
(c) Sensitization
3. Systemic Toxicity (In Vivo)
(a) Implantation Studies
(b) Developmental and Reproductive Toxicity (DART)
4. In vitro Biocompatibility Testing
(a) Cytotoxicity
(b) Hemocompatibility
(c) Genotoxicity
