FILAB : 1st French laboratory with ISO 17025 accreditation for the characterization of Medical Devices in accordance with the ISO 10993-18

Reminder : what is the ISO 10993-18 standard ?

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 analyses 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
  • Toxicological evaluation in accordance with the 10993-17 standard
  • 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.

 

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