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EN ISO 10993-9:2009 Standard

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  Keywords:

#product #standards #specific #methodologies #applicable

This standard is superseeded by:
  •   EN ISO 10993-9:2009 from: 2010-03-21 00:00:00
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 25th of March 2020

      Description:

    Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009)

      Purpose

    This part of ISO 10993 provides general principles for the systematic evaluation of the potential and observedbiodegradation of medical devices and for the design and performance of biodegradation studies.This part of ISO 10993 is not applicable to:a) viable-tissue engineered products;b) methodologies for the generation of degradation products by mechanical processes. Methodologies for theproduction of this type of degradation product are described in specific product standards, where available;c) leachable components which are not degradation products.Where product standards provide applicable product-specific methodologies for the identification and quantificationof degradation products, those standards shall be considered as alternatives.

      Publication

    Friday 17th of November 2017

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