ISO 10993-18 Laboratory: Chemical characterization of Medical Devices
ISO 10993-18 is a critical part of the ISO 10993 series, focusing on the chemical characterization of materials used in medical devices. For manufacturers, ensuring compliance with this standard is a regulatory requirement that directly impacts product safety, approval, and market access.
At Filab Laboratory, we provide specialized ISO 10993-18 testing services to support medical device manufacturers throughout the development and regulatory submission process. Our experts help you understand the chemical composition of your materials and ensure compliance with the latest international standards.
What is ISO 10993-18 ?
The ISO 10993-18 standard applies to the field of medical devices and specifies the requirements for the chemical characterization of materials (identification and quantification of chemical compounds) as part of biocompatibility testing on a Medical Device.
The chemical characterization of a material makes it possible to :
- Better understand the material being used in your production process
- Assess the leaching of chemical substances from Medical Devices
- Measure the balance of materials used in Medical Devices, as part of double sourcing or multi-sourcing
The chemical characterization of a material used in medical devices must be representative of its chemical nature, physical form and duration of clinical exposure and this must be established beforehand through toxicological risk assessment.
Why choose an ISO 17025 accredited laboratory to carry out your chemical characterizations in accordance with the ISO 10993-18 standard ?
Working with toxicologists and staying aware of regulatory changes, FILAB one of few French laboratories with ISO 17025 accreditation for the physicochemical analysis of Medical Devices.
Since summer 2019, the scope of our ISO 17025 accreditations has included the chemical characterization of materials in accordance with the ISO 10993-18 standard. We were therefore the first French laboratory to receive accreditation covering the ISO 10993-18 standard for the analysis of organic and inorganic residue.
This completes our set of ISO 17025 accreditations for tests on Medical Devices including THC/TOC analysis and inorganic residue analysis by ICP in accordance with the ISO 19227 standard (More information available at www.cofrac.fr – accreditation n°1-1793)
FILAB is able to provide a wide range of services, some under ISO 17025 accreditation, to assist you in assessing your biomaterials
FILAB laboratory has built up a diverse skillset in analytical chemistry and materials characterization to be able to provide services as part of the chemical characterization of all your biomaterials :
- Chemical characterization of materials in accordance with the ISO 10993-18:2018 standard
- Calculation of the AET
- Verification of extraction exhaustiveness in accordance with the ISO 10993-12 standard
- Detection and determination of organic and inorganic residue by ICP, GC-MS, LC-MS, HS-GC-MS
- Identification of impurities by LC-QToF
- Biological risk assessment in accordance with the 10993-1
- Analysis of cleaning residue in accordance with the ISO 19227:2018 standard
- THC/TOC analysis
- Analysis of inorganic residue
- Analysis of particulate contaminations
- Development, transfer and validation of analytical methods
- Problem solving : ruptures, surface contamination, adhesive problems, corrosion…
With three levels of services – analysis, expertise and R&D support – FILAB assists companies from all sectors and of all sizes in overcoming their industrial challenges by sharing its technical know-how and the wealth of experience of its team with its clients.
Why is ISO 10993-18 testing important?
- Patient safety: Identifies harmful substances that could leach from materials
- Regulatory approval: Required by authorities such as the FDA and notified bodies in Europe
- Global compliance: Recognized internationally across medical device markets
Laboratory services for ISO 10993-18 compliance
At Filab’s ISO 10993-18 laboratory, we offer a complete range of chemical characterization services tailored to medical device manufacturers. Our expertise includes:
- Identification of chemical substances released under simulated conditions
Quantification using advanced instrumentation (GC-MS, LC-MS, ICP-MS)
- Full profiling of polymers, metals, and composites used in medical devices
- Detection of additives, residual monomers, and potential contaminants
- Chromatography: HPLC, GC-MS
- Spectroscopy: FTIR, UV-Vis
- Mass spectrometry for trace-level detection
- ICP-MS for elemental impurities
Tailored studies based on device type, intended use, and regulatory requirements
Why choose Filab as your ISO 10993-18 laboratory?
- Accredited expertise: compliance with ISO/IEC 17025 standards
- State-of-the-art equipment for advanced chemical characterization
- Multidisciplinary team of chemists, toxicologists, and materials experts
- B2B focus: tailored support for industrial clients and medical device manufacturers
- Regulatory knowledge: assistance with FDA and CE-marking submissions
By choosing Filab, you partner with a laboratory that understands both technical challenges and regulatory expectations.
FAQ
All medical devices that come into direct or indirect contact with patients must undergo chemical characterization as part of their biocompatibility assessment.
Details about the device material, intended use, sterilization methods, and any additives used.
Yes. Many manufacturers rely on independent laboratories like Filab to conduct accredited testing and prepare compliant reports.
10993-18 provides the chemical data needed for toxicological risk assessment under ISO 10993-17.
