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Analysis and characterization services for medical devices in accordance with the ISO 10993-18 standard
What do we mean by implantable medical devices ?
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.
FILAB laboratory is able to assist you in characterizing your implants in accordance with the ISO 10993-18
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 :
- To get a better understanding of the materials used in your production process whether they be metallic, polymer or ceramic in nature
- To assess the leaching of substances by medical devices
- To measure differences between materials used in medical devices as part of multi-sourcing
This step is essential for implantable medical devices.
With ISO 17025 accreditation for these analyses, FILAB laboratory is able to offer complete services to assist you in your endeavors surrounding material characterization in line with the ISO 10993-18 :
- Calculation of the AET
- Verification of extraction exhaustiveness in accordance with the ISO 10993-12 standard
- Detection and determination of organic residue by HS-GC-MS, GC-MS, LC-MS/MS…
- Detection and determination of Inorganic residue by ICP-MS, ICP-AES, IC…
For all types of materials (polymers, metals, ceramics) and implantable devices.
Examples of services :
- Physicochemical characterization of an implantable textile
- Physicochemical characterization of a silicone catheter
- Physicochemical characterization of TA6V Titanium dental implants
- Physicochemical characterization of a metallic implantable prosthetic
FILAB is also able to provide the following services :
- Biocompatibility assessment in accordance with the ISO 10993 set (10993-18 / 10993-12 / 10993-13 / 10993-14 / 10993-15 / 10993-19 / 10993-22)
- R&D support : custom chemical analysis, material characterization, surface characterization, analytical development
- Problem solving : non-compliance, rupture, adhesive problem, corrosion…
- Validation of procedures : Cleaning (ISO 19227), Surface Treatment