Standard

NS-EN ISO 10993-3:2014

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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 SN
  • Publisert:
  • Utgave: 2014-10
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.100.20
  • National Committee SN/K 115

Referanser i lov

EU lov: 93/42/EEC, 90/385/EEC, 2007/47/EC

Produktrelasjon

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