Chemical characterization of medical device materials
According to ISO 10993-18 standard
FILAB laboratory confirms the biocompatibility of your medical devices according to the ISO 10993-18 standard. We are one of the first French laboratory accredited ISO 17025 by COFRAC* on ISO 10993-18.
From your sample’s handling to the interpretation of your results, our doctors and technicians guide you through the biocompatibility validation process of your medical devices.
How is biocompatibility of a material assessed according to ISO 10993 ?
In a changing regulatory context, the harmonized standards of the NF EN ISO 10993 series are the current references for the biological evaluation of medical devices and the biocompatibility of materials.
Thus, ISO 10993-18 is about chemical characterization of Materials.
Why do you need to submit your medical devices to an ISO 10993-18 analysis before they are put on the market?
In order to test the biocompatibility of your medical devices, qualitative and quantitative data must be collected on the materials that make up the devices in the context of biological safety. In the absence of such information, the material should be analyzed using appropriate techniques to collect data on its composition.
How FILAB can guide you through your need of biocompatibility validation process ?
FILAB is the first French laboratory to be COFRAC accredited for ISO 10993-18 analysis. Based on this experience, we have mastered the analysis of a large number of medical devices. But also, through our partners, we can assist you on other parts of the ISO 10993.
ISO 10993-1 (BRA) : Assessment and testing within a risk management process
ISO 10993-18 : Chemical characterization of medical device materials within a risk management process
ISO 10993-17 (TRA) : Establishment of allowable limits for releasable substances
What results can you expect from this analytical expertise?
The objective of this analytical expertise will be to identify and quantify the soluble and insoluble elements that will potentially be released from the Medical Device.
When should ISO 10993-18 be performed?
The ISO 10993-18 tests must be performed when developing a new medical device, when changing the manufacturing process or when changing materials and/or suppliers. Please be aware that even if a material has been historically shown to be biocompatible, it still must be testing ISO 10993-18.
Simulated, exaggerated or exhaustive extraction according to ISO 10993-18 ?
Simulated extraction : An extraction with simulated use is performed to estimate the type and quantity of substances expected to be released from a medical device during its clinical use.
Exaggerated Extraction : Extraction intended to result in the release of a larger number or quantity of chemical constituents than would be produced under clinical conditions of use.
Exhaustive Extraction : Multi-stage extraction performed so that the amount of extracted material recovered in a later step is less than 10% of that detected, by gravimetric analysis (or by any other means), in the initial extraction step.
FILAB : a laboratory dedicated to ISO 10993-18
FILAB has dedicated an entire department to ISO 10993-18. This unit is highly qualified in analytical chemistry and materials characterization. We also continue to invest in order to remain at the leading edge of analytical quality.
We have in-house all the instruments and techniques necessary for ISO 10993-18: ICP, GC, LC, CI.
FILAB offers tailor-made support, both in terms of price and technique for the analysis of your medical devices biocompatibility. Indeed, we develop the most suitable methods for your MDs and their use. And above all, our lead times are short and our prices very competitive.
Our doctors and technicians will support you during all the process of your sample’s analysis. At every step, they will explain you why and how your medical device is getting test. Above all, they stay at your disposal for any further questions about testings according to ISO 10993-18 standard.
Biocompatibility of your medical devices according to ISO 10993-18 but also...
ISO 10993-12: Sample preparation and reference materials
ISO 10993-13: Identification and quantification of degradation products of polymeric medical devices
ISO 10993-14: Identification and quantification of degradation products on ceramic materials
ISO 10993-19: Physicochemical, morphological and topographical characterization of materials
ISO 10993-22: Guidelines on nanomaterials
Customized chemical analysis
Characterization of materials
Development of analytical methods with ICHQ2 validation
Problem solving (adhesion of a coating on a material, corrosion, surface problems)
Why FILAB ?
With a team of 60 people including 5 doctors and 7 engineers, FILAB is an independent laboratory, experienced in the analysis and characterization of the surface of materials. Our human size, our multisectoral know-how and our permanent investments in the latest technologies guarantee our clients reliable results, rapid processing of requests and tailor-made support to our clients’ needs.
