Why study the surface properties of your medical devices?
First of all, what is meant by the surface of a medical device? It is an area made up of various specific characteristics. These can affect the medical device’s overall performance and potentially its reliability and strength in the event of failures.
Furthermore, the surface properties of medical devices also determine their quality and biocompatibility. They are therefore considered from the design of the medical device through to its biological evaluation.
In addition, understanding the properties and surface conditions of a material can help adapt your manufacturing processes. This makes it possible to implement specific surface treatment or cleaning processes.
FILAB supports you with the surface analysis of medical devices
In this context, advanced physicochemical techniques provide precise data on the surface analysis of medical devices, including the nature and composition of their outermost surface:
Morphological study of a material’s surface (porosity, roughness, etc.)
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
analysis according to ASTM A967/967M and A380/A380M
Measurement of the thickness of surface layers
Process validation: Cleaning (ISO 19227), surface treatment
Identification of surface contamination (particle and deposit analysis, etc.)
Validation of cleaning processes
analysis according to ASTM F86-21
Standards applicable to the surface analysis of medical devices...
The international standard ISO 19227, entitled “Surgical implants — Cleanliness of orthopedic implants — General requirements,” describes the requirements relating to the cleanliness of orthopedic implants and the validation of the cleaning processes used.
The ISO 10993-19 standard provides a set of parameters and analytical methods associated with the physical, morphological and topographical (PMT) characterization of medical devices. These parameters play an important role in biocompatibility assessment and in the screening of new materials. The surface properties studied include morphology, crystallinity, surface chemistry, porosity and biointeractions. They are determined using SEM, XPS or ToF-SIMS.
The ISO 10993-18:2020 standard — “Chemical characterization of materials used in medical devices” — focuses on soluble and insoluble extractables present on the device surface. Soluble extractables are identified after extraction, filtration and analysis by SEM and infrared microscopy.
