INTERNATIONAL WORKSHOP ON BIOCOMPATIBILITY EVALUATION OF MEDICAL DEVICES

The objective of the 4 days workshop is to expose the participants, the different parts of ISO 10993 and OECD standards for the biological evaluation of medical devices that come into direct or indirect contact with the human body. From concept to practical approach of ISO 10993 standard, this workshop will provide insights on
The need of biocompatible evaluation.

Global regulation on medical devices and biocompatibility testing guidelines.

Requirements for a valid biocompatibility test report and more.

Tentative workshop schedule
•Theory : ISO 10993 part 1, 3, 4, 5, 10, 11 and 12.
•Hands on training: ISO 10993 part 3, 4, 5, 10 and 12.
ISO 10993 – 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
ISO 10993 - 4 : Selection of tests for interactions with blood
ISO 10993 - 5 :Tests for in vitro cytotoxicity
ISO 10993 - 10 : Tests for irritation and skin sensitization
ISO 10993 - 12 : Sample preparation and reference materials
OECD 439 in vitro skin irritation

Expert speakers

Mrs. G.N. Geetha, Head, Microbiology and Mutagenicity

Mr. Sridhar, Senior Scientist        

Dr. Christian Pellevoisin, Scientific Director-SkinEthic Laboratory, France.

Mr. Vasudev Seeram, Scientist ,Bioneeds, Bangalore
 

Category           Registration fees (INR)

Students               7500 

Faculty                  10,000 

Industry                 15,000 

E mail registration form to the Head, CoE-Medical Textiles at coemed@sitra.org.in; sitrameditech@gmail.com.

Contact
Dr. E. Santhini, +91-9600923986
Ms. V.M. Pramila, +91-9944761380
Ms. K. Sujitha, +91-86809 69904