Your needs: conducting a biocompatibility study of your ceramic medical devices according to ISO 10993-14
What does ISO 10993-14 say?
The standard ISO 10993-14 is a framework established by the relevant authorities to ensure proper compliance of medical devices made of ceramic. It is part of the NF EN ISO 10993 series of standards ISO 10993 established for the evaluation of biocompatibility of medical devices. In addition, it makes it possible to assess the suitability of materials for performing a given function without causing adverse effects.
The ISO 10993-14 standard describes two analytical methods for identifying and quantifying degradation products of medical devices made of ceramic.
FILAB supports medical device manufacturers in the identification and quantification of degradation products from ceramic medical devices according to ISO 10993-14
Why choose FILAB for your ISO 10993-14 testing?
FILAB laboratory has a state-of-the-art analytical facility and highly skilled experts to meet the requirements of ISO 10993-14 and support medical device manufacturers in the identification and quantification of degradation products from ceramic medical devices.
Whatever your biomaterial, turn to an expert laboratory for the chemical characterization of your materials and the biocompatibility assessment of your medical devices:
Our expertise
FILAB also supports you with the following services:
Our services
R&D support: Tailored chemical analysis, material and surface characterization, analytical development
Process validation: Cleaning (ISO 19227), surface treatment
Problem solving: non-compliance, breakage, adhesion, corrosion...
Our human-scale organization, ongoing investment and knowledge of the medical device sector guarantee our clients reliable results, fast processing of requests and tailored support for their needs.
Our FAQ
ISO 10993-14 is intended for medical device manufacturers, testing laboratories, as well as regulatory and certification bodies. It is essential for research and development engineers, regulatory compliance specialists and quality control teams.
