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EN ISO 10993-18:2009 Standard

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  Keywords:

#device #assessment #material #equivalence #used

This standard is superseded by:
  •   EN ISO 10993-18:2020
  •   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 18: Chemical characterization of materials (ISO 10993-18:2005)

      Purpose

    This part of ISO 10993 describes a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications, for example: - As part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971). - Measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17). - Judging equivalence of a proposed material to a clinically established material. - Judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former. - Screening of potential new materials for suitability in a medical device for a proposed clinical application.

      Publication

    Friday 17th of November 2017

      Reference

    This standard supersedes the "EN ISO 10993-18:2005"

    Anyway is still possible use the "EN ISO 10993-18:2005" until March 21st, 2010

      Related Standards

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    EN ISO 11140-1:2009

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    Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

    EN ISO 11607-1:2009

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    EN ISO 11737-1:2006

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