Standard

ISO 10993-3:2014

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Obs: Denne standarden har et forslag: ISO/FDIS 10993-3

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Omfang

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially irreversible biological effects arising as a result of exposure to medical devices: genotoxicity; carcinogenicity; reproductive and developmental toxicity. ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • products.specs.Expires:
  • Utgave: 3
  • Versjon: 1
  • Varetype: IS
  • ICS 11.100.20
  • ISO TC ISO/TC 194

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