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Vanta Bioscience offers biocompatibility assessment solutions in accordance with ISO 10993 guidelines and the US FDA modified ISO matrix. Our team has the expertise in handling various devices and with the support of pharma services and the regulatory support team, we can develop a customized solution for your product development and commercialization needs.

The guideline documents from ISO 10993 (FDA's version #G95-1) followed at Vanta Bioscience include:
10993-1: Guidance on Selection of Tests
10993-2: Animal Welfare Requirements
10993-3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
10993-4: Selection of Tests for Interactions with Blood
10993-5: Tests for Cytotoxicity-In Vitro Methods
10993-6: Tests for Local Effects after Implantation
10993-7: Ethylene Oxide Sterilization Residuals
10993-9: Degradation of Materials Related to Biological Testing
10993-10: Tests for Irritation and Sensitization
10993-11: Tests for Systemic Toxicity
10993-14: Materials Evaluation

The US FDA modified ISO matrix is indicated below:

X = ISO Evaluation Tests for Consideration
O = Additional Tests which may be applicable
Note + Tissue includes tissue fluids and subcutanous spaces
Note ^ For all devices used in extracorporeal circuits

For more details on the specific tests, please click here