EN ISO 10993-3:2014 standard - CE Marking assistant

EN ISO 10993-3:2014 Standard

Home Active implantable medical devices Directive (90/385/EEC) EN ISO 10993-3:2014

Active implantable medical devices Directive EN ISO 10993-3:2014

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Keywords:

#part #tests #selection #risk #biological

Directive

Active implantable medical devices Directive (90/385/EEC)

Last Official Journal reference

Wednesday 25th of March 2020

Description:

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

Purpose

This part of ISO 10993 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.
This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity,
carcinogenicity, or reproductive toxicity has been established.
NOTE Guidance on selection of tests is provided in ISO 10993-1.