We offer services for biocompatibility / toxicity related testing of Medical Devices as per ISO guidelines.
ISO guideline | Studies |
ISO 10993 | Biocompatibility |
ISO 10993- 1:2009 | Evaluation and testing in the risk of management process |
ISO 10993-3 | Tests for genotoxicity, carcinogenicity and reproductive toxicity |
ISO 10993-4 | Selections of tests for interactions with blood |
ISO 10993-5 | Tests for in vitro Cytocompatibility evaluation |
ISO 10993-6 | Tests for local effects after implantation |
ISO 10993-10 | Tests for irritation and delayed-type hypersensitivity |
ISO 10993-11 | Tests for systemic toxicity |
ISO 10993-16 | Toxicokinetic study design for degradation products and leachables |
ISO 10993-20 | Principles and methods for immunotoxicology testing of medical devices |