Standard

ISO 10993-3:2026

Publisert

Obs: Denne standarden har et forslag: ISO 10993-3:2026

Forhåndsvisning

Rettelser og tillegg kjøpes separat.

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Omfang

This document specifies strategies for risk estimation and evaluation of biological harms with respect to: genotoxicity; carcinogenicity; reproductive toxicity; and developmental toxicity. This document is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity has been established. This document is not applicable to active pharmaceutical ingredients of device-drug combination products or biological components of device-biologic combination products which are covered by regulations. NOTE            Guidance on selecting relevant biological effects for medical devices is covered in ISO 10993-1.

Dokumentinformasjon

  • Standard fra ISO
  • Publisert:
  • Utgave: 4
  • Versjon: 1
  • Varetype: IS
  • ICS 11.100.20
  • ISO TC ISO/TC 194

Produktrelasjon

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