TESTING SERVICES

Testing services for biocompatibility and safety evaluation of biomaterials and medical devices are offered. About twenty of these tests are accredited by Le Comite Francais d’Acreditation (COFRAC) of France. 

Evaluation meeting the requirements of ISO 10993, ASTM, USP, etc.  in the following areas are available  :

·      CYTOTOXICITY testing using in vitro cell culture technique

·      TOXICOLOGICAL evaluation covering systemic toxicity, irritation,  sensitization, 

      implantation, pyrogenicity and bacterial endotoxins

·      HISTOPATHOLOGICAL evaluation of material–tissue interaction  

·      BLOOD COMPATIBILITY tests for screening of blood contacting materials and

      devices

·      MICROBIOLOGICAL studies for sterility, antimicrobial properties, monitoring of

      air & water, bacterial adhesion and bioburden estimation 

·      PACKAGE VALIDATION of medical devices

Characterization of materials as per international standards using analytical techniques like following are also available:

·     FT-IR & UV-Vis spectrophotometry

·     X-ray powder diffractometry

·     Thermal analysis (DSC, TGA, DTA)

·     HPLC and Gel Permeation Chromatograhy

·     Gas chromatography 

·     Tensile / Compressive testing

·     Energy Dispersive X-ray analysis (SEM-EDS)

Calibration: Calibration of instruments and specialised systems are being carried out routinely. This covers temperature & humidity (ovens and incubators), volumetric dispensers, spectrophotometers, electronic balances, SEM and efficacy testing of steam and ethylene oxide sterilisers.

Preclinical Studies: Facilities and expertise exist for preclinical safety and efficacy studies of medical devices using large animal models. More than two decades of experience in the evaluation of critical cardiovascular and neurosurgical products provides a strong base for taking up challenging programmes.

For further details on testing and evaluation contact

Customer Service Cell

Phone  :   +91-471-252-0307 or 234-0801  Extn 307

Fax      :    +91-471-234-1814

Email    :    csc@sctimst.ac.in