Analysis and expertise laboratory

ISO 10993-18: Customized training for your medical devices

5200 m² laboratory
5200 m² laboratory + 99% of services are provided in-house
Accredited laboratory
Accredited laboratory COFRAC ISO 17025
CIR
CIR Research tax credit

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

Pedagogical resources

  • Screening of training material
  • Handover of training material
  • Training led by experts in the techniques required

Target audience

Technicians or engineers in charge of research & innovation, process & industrialisation, production & maintenance, quality control, health, safety & environment, purchasing & supplies …

Program

For more information on the program, please contact us

Information updated on 09.10.2024

Practical information

  • In-company training
  • Questionnaire at the beginning and end of the course (Quizzes)
  • Attendance sheet
  • Duration: 2 days
  • PRM and PSH accessibility
  • Adaptable to customer needs
  • Price on quotation
  • No pre-requisites required for this course
  • A certificate of completion will be issued at the end of the course.
PRM and PSH access

Our training courses are accessible to people with disabilities. We will offer you solutions for adaptations (e.g. training aids, pace of training, teaching support, etc.) and adjustments to suit your needs.

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…

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.

To register for the course or to obtain a quote, please contact us directly by email or telephone.

Training will start within 3 months of acceptance of the agreement.

The filab advantages
A highly qualified team
A highly qualified team
Responsiveness in responding to and processing requests
Responsiveness in responding to and processing requests
A COFRAC ISO 17025 accredited laboratory
A COFRAC ISO 17025 accredited laboratory
(Staves available on www.cofrac.com - Accreditation number: 1-1793)
A complete analytical park of 5,200m²
A complete analytical park of 5,200m²
Tailor-made support
Tailor-made support
Thomas ROUSSEAU Scientific and Technical Director
Ask for your quote