Biocompatibility (Medical device) –ISO10993


• Acute or systemic toxicity (sub-acute, sub-chronic and chronic)

  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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