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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This standard is superseded by: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

    Active implantable medical devices Directive (90/385/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    This standard has been withdrawn on 2021-09-30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

      Related Standards

    EN ISO 10993-9:2009

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

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

    EN ISO 10993-18:2020

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

    Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management...

    EN ISO 10993-12:2012

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

    Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012)

    EN ISO 10993-11:2018

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

    Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

    EN ISO 13408-2:2018

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

    Aseptic processing of health care products - Part 2: Sterilizing filtration (ISO 13408-2:2018)

    EN ISO 25424:2019

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

    Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

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