As a medical device manufacturer, you want to conduct a degradation products study of your medical devices according to ISO 10993-15
Identification of degradation products
The materials used to manufacture medical devices may generate degradation products when exposed to their biological environment. The FILAB laboratory conducts degradation products studies of medical devices according to ISO 10993-15.
In this context, it is important to ensure that their level of tolerability is suitable for the safety of certain medical devices. To achieve this, investigations must be carried out to identify and quantify them.
What does ISO 10993-15 specify?
The ISO 10993-15 standard sets out the general principles for evaluating and designing degradation studies of materials used in medical devices. “Degradation” here means “decomposition of the material.” It deals exclusively with degradation products from metals and alloys. The FILAB laboratory supports you in conducting degradation products studies of medical devices according to ISO 10993-15.
The method used to evaluate degradation varies according to several factors:
- the nature of the material being studied,
- the medical device,
- its anatomical location
The FILAB laboratory supports you in conducting your medical device degradation products study according to ISO 10993-15
Why choose FILAB?
Two complementary standards to ISO 10993-15, specifically covering non-resorbable materials, describe these conditions:
- ISO 10993-13: Identification and quantification of degradation products from polymer-based medical devices
- ISO 10993-14: Identification and quantification of degradation products from ceramics
FILAB is the only laboratory accredited by COFRAC to ISO 17025 for all THREE material degradation tests: metals, polymers and ceramics.
Our medical device testing services
Our human scale, ongoing investments and knowledge of the medical device sector guarantee our clients reliable results, fast processing of requests and tailored support to meet their needs.
