ISO 10993-18: Customized training for your medical devices

Your teams need training on the ISO 10993-18 standard...

What is the ISO 10993-18 standard about?

The ISO 10993-18 standard describes a framework for the identification of a material and the determination and quantification of its chemical compounds. Therefore, ISO 10993-18 allows to ensure the biocompatibility of the medical device under study.

Indeed, the identification of biological hazards as well as the estimation and control of biological risks related to the constituents of materials according to the ISO 10993-18 standard are more than essential steps. Thus, several elements of chemical characterization are studied: 

  • the determination of chemical substances released by a medical device under its specific clinical use conditions
  • the identification of the materials constituting the medical device
  • characterization of the constituent materials via the identification and quantification of the chemical constituents (composition of the material)
  • chemical substances introduced during the manufacturing of the medical device: release agents, sterilization residues…

Why train to ISO 10993-18?

  • Calculation of the TEA

  • Impurity identification by LC-QTOF (database of more than 1000 substances)

  • Research and determination of organic and inorganic residues by ICP and CLI... 

  • Research and determination of organic residues by GC/MS, LC, HS/GCMS

  • Validation of extraction completeness according to ISO 10993-12

FILAB's ISO 10993-18 training...

As an accredited training organization, FILAB offers customized training for the analysis and chemical characterization of materials in medical devices in accordance with the requirements of ISO 10993-18.

At FILAB, we develop and offer our customers tailor-made training courses, in line with your industrial issues or analytical challenges.

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Thomas ROUSSEAU Scientific and Technical Director
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