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ISO 10993-3:2026

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

This document specifies strategies for risk estimation and evaluation of biological harms with respect to:

 
     
  • genotoxicity;
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  • carcinogenicity;
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  • reproductive toxicity; and
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  • developmental toxicity.
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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.

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International Organization for Standardization [iso]

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