Identification and quantification of degradation products on ceramic medical devices according to ISO 10993-14

Your needs: perform a biocompatibility study of your ceramic medical devices according to the ISO 10993-14 standard

The ISO 10993-14 standard is a reference standard set up by the competent authorities within the framework of the good conformity of ceramic medical devices. It is part of the NF EN ISO 10993 series of standards set up to assess the biocompatibility of medical devices. In addition, it allows the control of the ability of materials to perform a given function without adverse effects.

The ISO 10993-14 standard describes 2 analytical methods for the identification and quantification of degradation products of ceramic medical devices.

You are looking for a reliable and reactive laboratory to assist you in the analysis of your medical devices according to the ISO 10993-14 standard.

FILAB supports medical device manufacturers in the identification and quantification of degradation products of ceramic medical devices according to 10993-14

FILAB laboratory has a state-of-the-art analytical park of more than 2100 m2 and high level human skills. All of this has a specific goal: to offer services that meet their compliance criteria within the framework of the ISO 10993-14 standard.

Whatever your biomaterial, call on a laboratory of expertise for the chemical characterization of your materials and the evaluation of the biocompatibility of your medical devices:

our expertise

  • Chemical characterization of materials according to ISO 10993-18

  • Identification and quantification of degradation products of polymeric medical devices according to ISO 10993-13

  • Preparation of samples and reference materials according to ISO 10993-12

  • Characterization of nanomaterial-based medical devices according to ISO 10993-22

For more information on our analysis services for your medical devices according to the ISO 10993-14 standard, contact us via contact@filab.fr or at 03 80 52 32 05.

FILAB also assists you with the following services: 

Our services

  • Biocompatibility study according to ISO 10993 ( -18 / -12 / -13 / -14 / -15 / -19 / -22 )

  • Problem solving: non-conformity, breakage, adhesion, corrosion...  

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

  • Process validation: Cleaning (ISO 19227), surface treatment

Our human size, our permanent investments and our knowledge of the medical devices sector guarantee to our customers a reliability of the results, a fast treatment of the requests and a tailor-made support of their needs.

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