As a manufacturer, you want to realise Extractables and Leachables analysis according to FDA guidance
ISO 10993-18 regulations on Extractables and Leachables
ISO 10993-18 is part of the ISO 10993 series of international standards for assessing 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, guaranteeing comprehensive analysis of your device components, according to the standard.
This rigorous process helps to identify and quantify extracted substances and degradation products that may be released from materials during clinical use.
Why carry out an analysis of E&L ?
For medical device manufacturers wishing to export their products, navigating the US regulatory landscape and meeting the stringent requirements of the Food and Drug Administration (FDA) can prove 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 guaranteeing the safety and efficacy of medical devices, plays an important role in the FDA approval process, which is a prerequisite for access to the US market.
What are the FDA's recommendations for ISO 10993-18 ?
ISO 10993-18 is widely recognized and used throughout the world, including by the U.S. Food and Drug Administration (FDA), to assess the biological safety of medical devices.
The FDA uses this standard as part of an overall assessment of the biocompatibility 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 stresses 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 releasable substances in materials, which could influence device safety. FILAB can help you ensure that your medical device complies with ISO 10993-18 for successful export to the USA.
The FDA recommends the use of appropriate, validated analytical methods to ensure the accuracy of chemical characterization results.
FILAB can help you to realise Extractables and Leachables analysis according to FDA guidance
Why choose FILAB ?
For over ten years, the FILAB laboratory has developed extensive expertise in chemical analysis and material characterization, and works with recognized toxicological risk assessors to provide a comprehensive service for the chemical characterization of all your medical devices. FILAB supports DM manufacturers in the analysis of their DM according to ISO 10993-18 and FDA recommendations.
Accredited COFRAC 17025 for these analyses, FILAB offers a complete range of services to support you in your characterization procedures according to the requirements of IOS 10993-18.
