Analysis and characterization services for medical devices in accordance with the ISO 10993-18 standard
Anaïs DECAUX
Customer Support Manager
Ask for your quote
Home • Our services • Expertise • Laboratory biocompatibility tests in accordance with ISO 10993 • Analysis and characterization services for medical devices in accordance with the ISO 10993-18 standard
An implantable medical device is an invasive device designed to stay in the patient’s body : ex. Catheters, orthopedic implants, dental implants…
As a class 3, the criticality of implantable medical devices is high and requires important quality control procedures for such a device to be authorized to go to market.
The assessment of the biocompatibility of a medical device is carried out in accordance with the ISO 10993-18 standard, which refers to the ISO 10993-18 standard for the physicochemical analysis of materials. This step has multiple uses :
This step is essential for implantable medical devices.
With ISO 17025 accreditation for these analysis, FILAB laboratory is able to offer complete services to assist you in your endeavors surrounding material characterization in line with the ISO 10993-18 :
For all types of materials (polymers, metals, ceramics) and implantable devices.
Our characterization services – ISO 10993-18 :
Download our brochure on Medical Devices
FILAB is also able to provide the following services :