Most recent

ONORM EN ISO 10993-3:2015

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) (Austrian Standard)

ISO 10993-3 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 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

CONTENT PROVIDER
Austrian Standards Institute [on]

Included in Packages
This standard is not included in any packages.
Document History
Revises:
Amendments & Corrections
We have no amendments or corrections for this standard.