Chemical characterization of medical devices according to ISO 10993-18 & FDA guidance
ISO 10993-18 Guidelines for Extractables and Leachables Testing According to FDA Recommendations
The FDA draft guidance on “Chemical Analysis for Biocompatibility Assessment of Medical Devices” sets forth a comprehensive approach to chemical characterization.
Following ISO 10993-18, it outlines requirements for extraction, analytical testing, and documentation, aiming to ensure reliable and consistent chemistry studies that support the safety and efficacy of medical devices.
FILAB: Your Partner for FDA-Compliant Extractables and Leachables Testing
Why Choose FILAB for ISO 10993-18 Analysis According to FDA Guidance?
FILAB offers expertise and state-of-the-art facilities to help medical device manufacturers comply with FDA recommendations and ISO 10993-18 standards.
- Regulatory expertise: in-depth knowledge of FDA guidance ensures analyses meet all regulatory expectations
- ISO 10993-18 Compliance: all chemical characterization studies follow international standards for extractables and leachables
- Advanced analytical facilities: over 5,200 m² of fully equipped laboratories
- Accreditation: FILAB is COFRAC-accredited for ISO 10993-18
- Reliable documentation & reporting
Choosing FILAB ensures safe, reliable, and FDA-compliant extractables and leachables analyses, leveraging accredited facilities and advanced expertise to support medical device manufacturers.
Our services according to ISO 10993-18 (Chemical characterization of medical devices)
Guarantee complete chemical extraction of devices following ISO 10993-12
Analysis of organic residues
Calculation of AET
Analysis of inorganic residues
Extraction procedures: guidelines and best practices
The FDA guidance highlights the critical role of proper extraction procedures in ensuring reliable chemical analysis of medical devices. These procedures are designed to provide worst-case estimates of analytes while maintaining device integrity. Key considerations include:
- Extraction conditions
- Solvent Compatibility
- Non-Volatile Residue (NVR) Analysis
Following these guidelines ensures consistent, reliable, and reproducible chemical analysis in line with FDA guidance and ISO 10993-18, supporting the safety and performance of medical devices.
FAQ
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.
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.
