Materials used in the manufacture of medical devices 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, by conducting investigations to identify and quantify them.
The ISO 10993-9 standard brings together the different general principles for the evaluation and design of degradation studies of materials used in Medical Devices – “degradation” meaning here “decomposition of the material”. It deals only with degradation products resulting from chemical alteration of the device in the human body, not from mechanical stress or wear. Also, it is important to note that this standard does not refer to the extractable and leachable compounds studied in Part 18 of ISO 10993.
The method of assessing degradation will vary depending on the nature of the material being studied, the medical device and its anatomical location.
FILAB laboratory assists you in the identification and quantification of degradation products in your medical devices according to ISO 10993-9
Three standards complementary to ISO 10993-9 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
- ISO 10993-15: Identification and quantification of degradation products from metals and alloys
FILAB provides more comprehensive support for the biocompatibility assessment of your devices, including the following tests
- Chemical characterization according to ISO 10993-19
- Chemical characterization according to ISO 10993-18
- Characterization of nanomaterials according to ISO 10993-22
Our human size, our permanent investments and our knowledge of the medical devices sector guarantee our customers reliable results, rapid processing of requests and tailor-made support for their needs.
