Chemical analysis and characterization services for implantable medical devices according to ISO 10993-18

The biocompatibility assessment of a medical device is carried out in accordance with ISO 10993-1, which refers to ISO 10993-18 for the physico-chemical analysis of the materials used. This step makes it possible, among other things, to:

• Gain a better understanding of the material used in your production process, whether metallic, polymer, or ceramic materials
• Assess the leaching of chemical substances from medical devices
• Measure the equivalence of materials used in medical devices, including in the context of dual or multi-sourcing

This step is particularly essential for implantable medical devices.

COFRAC 17025 accredited for these analyses, FILAB laboratory offers you a complete service to support your characterization efforts in line with the requirements of ISO 10993-18:

• AET calculation
• Validation of extraction completeness according to ISO 10993-12
• Identification and quantification of organic residues by HS/GC-MS, GC-MS, LC-MSMS…
• Identification and quantification of inorganic residues by ICP-MS, ICP-AES, CLI…

For all types of materials (polymer, metal, ceramic) and implantable devices.

Examples of work:

• Physico-chemical characterization of an implantable textile
• Physico-chemical characterization of a catheter in silicone
• Physico-chemical characterization of dental implants in TA6V
• Physico-chemical characterization of a metallic implantable prosthesis

FILAB also supports you with the following services:

• Study of Biocompatibility according to ISO 10993 (-18 / –12 / –13 / –14 / -15 / -19 / –22)
• R&D support: Custom chemical analysis, materials and surface characterization, analytical development
• Problem solving: non-conformity, failure, adhesion, corrosion…
• Process validation: Cleaning (ISO 19227), surface treatment