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Biocompatibility studies
Biocompatibility (Medical device) –ISO10993
• Acute, sub-acute, sub-chronic and chronic toxicity
ISO 10993-11 (2017)
• Genotoxicity, carcinogenicity, and reproductive toxicity
ISO 10993-3 (2014)
• In vitro cytotoxicity
(extract and direct contact assays)
ISO 10993-5 (2009)
• Irritation and skin sensitization
ISO 10993-10 (2010) and ISO 10993-23 (2021)
• Local tolerance after implantation
ISO 10993-6 (2016)
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