As an industrial manufacturer, you want to carry out the analysis of your medical devices according to ISO 10993-18 and FDA recommendations
What does ISO 10993-18 say?
The ISO 10993-18 standard is part of the ISO 10993 series of standards, which are international standards for evaluating the biocompatibility of medical devices.
This standard focuses on the chemical characterization of the materials used. Our laboratory offers in-depth expertise in the medical device industry, ensuring comprehensive analysis of your equipment components in accordance with the standard.
This rigorous process helps identify and quantify extractable substances and degradation products that may be released from the materials during clinical use.
Why perform a medical device analysis according to ISO 10993-18?
For medical device manufacturers wishing to export their products, navigating the US regulatory landscape and meeting the strict requirements of the Food and Drug Administration (FDA) can be complex, especially when it comes to compliance with specific standards such as ISO 10993-18, dedicated to assessing the biocompatibility of medical materials.
This standard, which is essential for ensuring the safety and effectiveness of medical devices, plays an important role in the FDA approval process, a mandatory step for accessing the US market.
What are the FDA's recommendations regarding ISO 10993-18?
ISO 10993-18 is widely recognized and used worldwide, including by the Food and Drug Administration (FDA) of the United States, to assess the biological safety of medical devices.
The FDA uses this standard as part of an overall biocompatibility assessment of medical devices, as specified in its guidance document “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process'”. In this document, the FDA emphasizes the importance of thorough chemical characterization according to ISO 10993-18 as a key step in determining the biological risks associated with medical devices. The agency expects manufacturers to provide comprehensive data on extractable and/or leachable substances from materials that could affect device safety. FILAB supports you in ensuring your medical device’s compliance with ISO 10993-18 for successful export to the United States
The FDA recommends using validated and appropriate analytical methods to ensure the accuracy of chemical characterization results.
FILAB laboratory supports you in the analysis of medical devices according to ISO 10993-18 and FDA recommendations
The FILAB laboratory supports you in medical device analysis according to ISO 10993-18 and FDA recommendations
For more than ten years, the FILAB laboratory has developed extensive expertise in chemical analysis and material characterization and works with recognized toxicological risk assessors to provide you with a comprehensive service for the chemical characterization of all your medical devices. FILAB supports medical device manufacturers in analyzing their devices according to ISO 10993-18 and FDA recommendations.
Accredited by COFRAC 17025 for these analyses, FILAB laboratory offers a complete solution to support you in your characterization processes in accordance with the requirements of standard ISO 10993-18.
