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EN ISO 10993-11:2009 Standard

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  Keywords:

#reactions #materials #cause #adverse #systemic

This standard is superseded by:
  •   EN ISO 10993-11:2018
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

      Purpose

    This part of ISO 10993 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-09-30

      Reference

    This standard supersedes the "EN ISO 10993-11:2006"

    Anyway is still possible use the "EN ISO 10993-11:2006" until March 21st, 2010

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