Identification and quantification of degradation products from polymer-based Medical Devices in accordance with the ISO 10993-13 standard

Your needs : to study degradation products from your polymer-based medical devices in accordance with the ISO 10993-13 standard

The ISO 10993-13 standard is part of the ISO 10993 set implemented for the assessment of the biocompatibility of medical devices. These biocompatibility tests are conducted to verify the aptitude of materials to carry out a given function without having undesired side effects.

The ISO 10993-13 standard specifies the relevant regulations surrounding the identification and quantification of degradation products from polymer-based Medical Devices.

Degradation products analyzed following the ISO 10993-13 may be the result of chemical alteration.

Are you looking to cooperate with a reliable and reactive laboratory for assistance in analyzing your medical devices in accordance with the ISO 10993-13 standard ? Feel free to contact us !

Our solution : to assist Medical Device producers in testing the biocompatibility in accordance with the ISO 10993-13 standard for the identification and quantification of degradation products

For over 10 years, FILAB laboratory have been developing a diverse analytical skillset applied to chemical analysis and material characterization. FILAB laboratory is equipped with a cutting-edge analytical fleet spread over 2100m² of laboratory space to be able to provide Medical Device producers with services fulfilling their criteria in terms of product compliance relating to the ISO 10993-13 standard.

Whatever your biomaterial, you can call upon an expert laboratory for the chemical characterization of your materials and the assessment of the biocompatibility of your Medical Devices :

our expertise

  • Chemical characterization of materials in accordance with the ISO 100993-18 standar

  • Characterization of Medical Devices containing nanomaterials in accordance with the ISO 10993-22 standard

  • Sample preparation in accordance with the ISO 10993-12 standard

  • Identification and quantification of degradation products from polymer-based medical devices in accordance with the ISO 10993-13 and ISO 10993-14 standards

FILAB is also able to provide the following services : 

Our services

  • Biocompatibility testing in accordance with the ISO 10993 set (ISO 10993-18 / ISO 10993-12 / ISO 10993-14 / ISO 10993-15 / ISO 10993-19 / ISO 10993-22)

  • Problem solving : non-compliance, ruptures, adhesive problems, corrosion…

  • R&D support : custom chemical analysis, material characterization, surface characterization and analytical development

  • Procedure validation : cleaning (ISO 19227), surface treatment

The fact that we work on a human scale, our continuous investments and our extensive knowledge of the field of Medical Devices all ensure the reliability of our results, a quick turnaround for requests and tailored support suited to your needs.

For more information about or analytical services for your Medical Devices in accordance with the ISO 10993-13 standard, feel free to contact us via email at contact@filab.fr or over the phone by calling +33 (0)3 80 52 32 05.

Thank you !

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