Toxicology Studies
1. Systemic toxicity study
2. Irritation Studies
3. Skin Sensitization Study
4. Pyrogen Tests
5. Implantation studies
6. Invitro Cytotoxicity Test
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Shanmuga Nagar, Padappai, Tamil Nadu 601301
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Working Hours : 24/7
NABL MEDICAL DEVICES
NABL MEDICAL DEVICES
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: