Characterization of the passivation of medical devices
Your needs: check the corrosion resistance performance of your implants
What is a passivation process?
Passivation is a chemical process that consists of treating the surface of a metal alloy in order to cover it with a uniform and compact layer of oxides thus improving its resistance to corrosion by acting as a barrier against external aggressive elements.
Why characterize the passivation of medical devices?
The surfaces of implants are the preferred sites for interactions with the biological host environments. In order to avoid adverse effects after deployment in the human body, medical devices must therefore have excellent corrosion resistance. Optimizing the corrosion resistance of medical devices is therefore essential for the biomedical field.
Therefore, the FDA requires supporting data to demonstrate that a medical device has sufficient corrosion resistance. Thus, controls must be carried out in order to verify the integrity and the thickness of the treatments, the conformity of the specifications, the corrosion resistance performance, …
Our solutions: characterize your passivation treatments and evaluate their performance
Our laboratory services to evaluate passivation processes
For more than 30 years, our FILAB laboratory has had the know-how and complementary state-of-the-art analytical equipment to support manufacturers in the medical device sector in the characterization of passivation treatments, both in the context of control and in the framework of failure assessment and process optimization.
The FILAB laboratory thus offers a multisectoral expertise in the face of several types of requests related to the passivation of medical devices:
- Characterization of the metallic and oxide forms of the chemical elements present on the surface of a medical device
- Observation of the uniformity and integrity of a surface treatment
- Measurement of the passivation thickness of a medical device
- Corrosion resistance test (salt spray test, …)
- Expertise of a corrosion initiation observed on a passivated device
- Support for the optimization of a passivation process of a metallic implant in titanium alloy or stainless steel.
For this type of service, the FILAB laboratory uses state-of-the-art analysis techniques such as Scanning Electron Microscopy coupled with a microprobe (SEM FEG-EDX), X-ray Photoelectron Spectroscopy (XPS) associated with corrosion tests (salt fog chamber) or even elementary analysis techniques (ICP-AES, ICP-AES, CLI)
