Why study the surface properties of your medical devices?
First of all, what is the surface of a medical device? It is an area composed of different specific characteristics. These can impact the overall performance of the medical device and potentially its reliability and robustness in case of failure.
In addition, the surface properties of medical devices also condition their qualities and biocompatibility. They are thus the subject of interrogations at the time of the creation of the medical device until its biological evaluation.
Moreover, the knowledge of the properties and surface states of a material can allow you to adapt your manufacturing processes. Thus, it is possible to implement specific surface treatment or cleaning processes.
FILAB supports you in the surface analysis of medical devices
In this context, advanced physico-chemical techniques make it possible to obtain precise data on the surface analysis of medical devices, including the nature and composition of the extreme surface:
Morphological study of the surface of a material (porosity, roughness,...)
Study of surface extractables and leachables according to ISO 10993-18
PMT study according to ISO 10993-19
Study of degradation products according to ISO 10993-9/-13/-14/-15
Measurement of the thickness of surface layers
Process validation: Cleaning (ISO 19227), surface treatment
Identification of surface pollution (analysis of particles, deposits, etc.)
Cleaning process validation
The standards that accompany the surface analysis of medical devices...
The international standard ISO 19227, entitled “Surgical Implants – Cleanliness of Orthopaedic Implants – General Requirements”, describes the requirements for the cleanliness of orthopaedic implants and the validation of the cleaning processes used.
ISO 10993-19 provides a set of parameters and analytical methods associated with the physical, morphological and topographical (PMT) characterization of DM. Indeed, these parameters play an important role in the evaluation of biocompatibility but also in the screening of new materials. The surface properties studied are: morphology, crystallinity, surface chemistry, porosity, bio interactions. They are obtained by SEM, XPS or ToF-SIMS.
The ISO 10993-18:2020 standard – “Chemical characterization of medical device materials” – studies the soluble and non-soluble extractables present on the surface of the device. For soluble extractables, they are identified after extraction, filtration and analysis by SEM and Infrared Microscopy.
