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EN ISO 10993-3:2014 Standard

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  Keywords:

#part #tests #selection #risk #biological

  Directive

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

  Last Official Journal reference

Wednesday 14th of April 2021

  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.

  Publication

Friday 17th of November 2017

  Related Standards

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Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products (...

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