OBJECTIFS
Identification of impurities by LC-QTOF (database of more than 1,000 substances)
Teaching methods
- Presentation of the training materials
- Distribution of the training materials
- Training led by experts in the requested techniques
Target audience
Technicians or engineers in charge of research & innovation, process & industrialization, production & maintenance, quality control, hygiene, safety & environment, purchasing & procurement …
Program
- Context and evolution of ISO 10993-18 standard
- Principles and applications
- Analytical conditions
- Extractables conditions
- Methods and instruments
- AET calculation
- Extractables identification
- Discussion of real-world cases encountered
Information updated on 09.10.2024
Practical information
- In-company training
- Questionnaire at the start and end of the training (quiz)
- Attendance sheet
- Duration: 2 days
- Accessibility: PRM and PWD
- Adaptable to the client’s needs
- Price on request
- A certificate of completion will be issued to participants at the end of the training
Our training courses are accessible to people with disabilities. We will offer adapted solutions (for example: training materials, training pace, educational support, etc.) and adjustments according to your needs.
Your teams need training on ISO 10993-18...
What is ISO 10993-18 all about?
The ISO 10993-18 standard describes a framework used to identify a material and determine and quantify its chemical compounds. As such, ISO 10993-18 helps ensure the biocompatibility of the medical device under study.
Indeed, identifying biological hazards as well as estimating and controlling the biological risks associated with material constituents according to ISO 10993-18 are more than essential steps. Several chemical characterization elements are therefore studied:
- the measurement of chemical substances released by a medical device under its specific clinical use conditions
- the identification of the materials making up the medical device
- the characterization of the constituent materials through the identification and quantification of chemical constituents (material composition)
- the chemical substances introduced during the manufacture of the medical device: release agents, sterilization residues…
Training according to the ISO 10993-18 standard from FILAB...
As an approved training organization, FILAB offers you custom training for the analysis and chemical characterization of materials on medical devices in light of the requirements of ISO 10993-18.
At FILAB, we develop and offer our clients only customized training courses, aligned with your industrial challenges or analytical needs.
To register for the training or to obtain a quote, please contact us directly by email or phone.
The training will start within 3 months from the acceptance of the agreement.
Why choose FILAB for any training in analytical chemistry or materials?
The FILAB laboratory is QUALIOPI certified for its training activities.
Thanks to this certification, the training courses we provide may be eligible for funding requests from OPCOs.
Analytical training is essential for professionals seeking to master analysis and characterization techniques; indeed, it covers a wide range of techniques intended for the analysis and characterization of substances, materials, or products in various industrial sectors.
Our analytical training programs are designed to equip participants with the skills needed to excel in their field, combining rigorous theory with practical applications. Discover how our analytical training can transform your skill set within your company.
Several reasons explain the growing number of training requests received by FILAB:
Tailor-made technical training: most of the training courses offered by many training organizations are standard, not tailored to your needs, and do not address your technical challenges
Highly qualified professionals: our trainers are laboratory staff, specialized PhD holders or engineers
Industrial expertise: FILAB has been providing training to its clients for over 10 years, regardless of the industrial sector
A unique profile with dual expertise in Chemistry and Materials
A human-sized organization, allowing us to provide greater responsiveness and flexibility
ISO 10993-18: when training your teams boosts compliance and innovation
- Development of new medical devices
- Anticipation of regulatory audits and inspections
- Optimization of interactions with subcontractors and partner laboratories
- Continuous improvement and product innovation
- Reduction of costs related to analytical and regulatory errors
FAQ
The objectives include: AET calculation, identification of impurities by LC-QTOF (database of >1,000 substances), quantification of organic and inorganic residues (ICP, CLI, GC/MS, LC, HS/GCMS), and validation of extraction completeness according to ISO 10993-12.
It is intended for medical device manufacturers, quality and regulatory affairs managers, as well as R&D engineers seeking to master best practices in chemical characterization.
The training strengthens expertise in biological evaluation, safeguards your regulatory dossiers, reduces the risks associated with non-compliance, and optimizes the development of innovative medical devices.
FILAB laboratory offers a tailored approach, combining expertise in analytical chemistry with regulatory experience to effectively support your compliance and innovation projects.
ISO 10993-18 defines the requirements for the chemical characterization of materials used in medical devices. It enables the identification and quantification of extractable and leachable substances in order to assess their potential impact on human health. This step is essential for demonstrating a device’s biocompatibility, ensuring its safety in clinical use, and meeting international regulatory requirements.
