With regard to the materials used in the manufacture of medical devices, they can generate degradation products when exposed to their biological environment.
In this context, it is important to ensure their level of tolerability for the safety of certain medical devices. To do this, investigations must be carried out to identify and quantify them.
The ISO 10993-15 standard gathers the different general principles for the evaluation and design of degradation studies of materials used in Medical Devices. “Degradation” here means “decomposition of the material”. It deals only with degradation products from metals and alloys.
The method of evaluating degradation varies according to several elements:
the nature of the material studied,
the medical device
its anatomical location
FILAB laboratory can assist you in the identification and quantification of degradation products in your medical devices according to ISO 10993-15
Two standards complementary to ISO 10993-15 and specific to non-resorbable materials describe these conditions:
- ISO 10993-13: Identification and quantification of degradation products of polymer-based medical devices
- ISO 10993-14: Identification and quantification of degradation products of ceramics
FILAB can assist you in the analysis of your medical devices, including the following tests
- Chemical characterization according to ISO 10993-19 and ISO 10993-18
- Characterization of nanomaterials according to ISO 10993-22
- HCT and TOC analysis according to ISO 19227
Our human size, our permanent investments and our knowledge of the medical devices sector guarantee our customers a reliability of the results, a fast treatment of the requests and a tailor-made support of their needs.
