Bio-compatibility / Toxicology Tests


Astute labs Pvt Ltd offers testing services for the medical devices as per ISO 10993 series of standards,

EN ISO 10993-5:2009 In vitro cytotoxicity in L929

EN ISO 10993-10:2010 Intracutaneous reaction in rabbits

EN ISO 10993-11:2006 Systemic injection test in mice

EN ISO 10993-11:2006 Systemic injection test in mice with polar and non polar extract

EN ISO 10993-10:2010 Primary Skin Irritation test

EN ISO 10993-10:2010 Mucous Membrane Irritation Test

EN ISO 10993-10:2010 Mucous membrane irritation test with polar and non polar extract

EN ISO 10993-6:2007 Acute implantation test in rabbits

EN ISO 10993-6:2007 Subacute implantation in rabbits…30 days

EN ISO 10993-6:2007 Subacute implantation in rabbits …90 days



EN ISO 10993-4:2002 Haemocompatibility test

EN ISO 10993-10:2010 Skin sensitization test in guinea pigs

EN ISO 10993-10:2010 Skin sensitization test with polar and non polar extract in guinea pigs

EN ISO 10993-3:2003 Genotoxicity Test option 1 of ISO 10993-3


   a. AME’S Test

   b. In Vitro Genotoxicity Test OECD 473


   c. In Vitro Genotoxicity Test OECD 476


EN ISO 11737-1:2006 Bio Burden test

EN ISO 11737-1:2006Sterility test

EN ISO 10993 Part 10:2010 Irritation

EN ISO 10993 Part 10:2010 Intracutaneous reactivity

Astute Labs Pvt Ltd