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ISO 10993-3:2026

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Note: This standard has a draft: ISO 10993-3:2026

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Abstract

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.

Document information

  • Standard from ISO
  • Published:
  • Expires:
  • Edition: 4
  • Version: 1
  • Document type: IS
  • ICS 11.100.20
  • ISO TC ISO/TC 194

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