Identification and quantification of potential degradation products in accordance with the ISO 10993 set

ISO 10993-9 and Medical Devices

The ISO 10993-9 standard specifies the general principles for the conception and examination of a study into potential degradations of materials used in Medical Devices.

The data collected during these studies could be useful when evaluating the toxicological risks of Medical Devices (resorbable or non-resorbable materials)

Three complementary standards allow for degradation products to be identified and quantified:

  • ISO 10993-13: Identification and quantification of degradation products from polymer-based medical devices
  • ISO 10993-14: Identification and quantification of degradation products from ceramics.
  • ISO 10993-15: Identification and quantification of degradation products from metals and alloys

What FILAB can do for you

The implementation of degradation analyses depends on collaboration and information exchanges between characterization specialists, analytical specialists and toxicologists.  

 For over ten years, the FILAB laboratory has been developing a wide skillset in analytical chemistry and material characterization and has been collaborating with toxicology experts when conducting biodegradation analyses on your biomaterials:

  • Quantitative and qualitative analyses of degradation products from ceramics in accordance with ISO 10993-14
  • Quantitative and qualitative analyses of degradation products from polymers in accordance with ISO 10993-13
  • Quantitative and qualitative analyses of degradation products from metallic alloys in accordance with ISO 10993-15

In the context of an examination of the quality and security of your Medical Devices, the FILAB laboratory can offer complementary analytical services with high added value:

  • Chemical characterization of materials in accordance with ISO 10993-18
  • Custom chemical analyses
  • Ceramic analyses (ex. Dental fillings)
  • Elemental analyses
  • Impurity analyses
  • Material characterization
  • Heavy metal analysis
  • Sampling of reference materials in accordance with ISO 10993-12
  • Cleaning residue analysis (THC/TOC)
  • Metallurgical analysis of Medical Devices
  • Development of new, custom analytical methods

Discover the analytical techniques we use at FILAB here

To know more about the analytical services offered at FILAB click here

For more information, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05

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