Biocompatible

In vitro skin irritation test according to ISO 10993-23:2021

Regulatory reference:	ISO 10993-23:2021.
Claim:	Biocompatible
Application field:	Raw materials and finished products.
Description of the test:	In vitro skin irritation test for solid medical devices according to ISO 10993-23:2021.

Posted in Filter devices, shielding films and plasters, Protection and barrier effect, Raw materials for medical devices, Surgical devices and medications, Claim for medical devices, Biocompatible

Cytotoxicity test for the identification of substances with acute oral toxicity LD50>2000 mg/kg

Regulatory reference:	OECD 129: on using cytotoxicity tests to estimate starting doses for acute oral systemic toxicity tests; EURL-ECVAM 2011: follow-up study on the predictive capacity of the 3T3 Neutral Red Uptake cytotoxicity assay to correctly identify substances not classified for acute oral toxicity under the EU CLP system.
Claim:	Biocompatible and Non citotoxic
Application field:	Chemical substances or mixtures.
Description of the test:	The in vitro LD50 prediction test is designed to test chemicals or mixtures by evaluating their cytotoxic effect on an in vitro model of BALB/c 3T3 murine fibroblasts.

Posted in Non citotoxic, Cosmetic raw materials, Claim for cosmetics, Biocompatible

Biocompatibility test

Regulatory reference:	ISO 10993-10
Claim:	Biocompatible
Application field:	Finished products, textiles, solid products by eluate.
Description of the test:	Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential.

Posted in Vaginal products and Condom, Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Raw materials for medical devices, Substance-based, Surgical devices and medications, Claim for medical devices, Biocompatible