objectifs
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 responsible for research & innovation, process & industrialization, production & maintenance…
Program
For more information about the program, please contact us
Information updated on 07.10.2024
Practical information
- In-house training
- Questionnaire at the beginning and end of the training (quiz)
- Attendance sheet
- Duration: 2 days
- Accessibility for PRM and PWD
- Adaptable according to the client’s needs
- Price on request
- No prerequisites are required to take this course
- A certificate of completion will be issued to beneficiaries at the end of the training
Nos formations sont accessibles pour les personnes en situation de handicap. Nous vous proposerons des solutions d'adaptations (exemple : supports de formation, rythme de la formation, soutien pédagogique, etc.) et d'aménagements en fonction de vos besoins.
Do your teams need training in cleaning residue analysis on medical devices according to ISO 19227?
What is ISO 19227?
The international standard ISO 19227, published under the title “Surgical implants — Cleanliness of orthopaedic implants — General requirements”, sets out the requirements relating to the cleanliness of orthopaedic implants as well as the validation of the cleaning processes used.
Implementing the ISO 19227 standard requires several complex steps carried out upstream by medical device manufacturers:
- A complete review of the risk analysis related to cleaning. Risk management is an iterative process that must be carried out by the client throughout the design, validation and use of the cleaning process.
- The design of a cleaning process based on the implant’s characteristics, its expected performance and its manufacturing steps.
- The definition of minimum cleanliness criteria after final cleaning
- The validation of cleaning methods for each type of implant
- The biological evaluation according to ISO 10993-1 and validation of the sterilization process
In this process, FILAB laboratory (ISO 17025 accredited for cleaning residue analysis) supports companies with the chemical analysis of cleaning residues (organic HCT/COT contaminants, inorganic and acidic residues, particulate contaminants) on medical devices.
Training on ISO 19227 by FILAB...
Do you want to carry out a cleaning residue analysis on your MDs? Are the competent person or persons no longer part of your teams? Do you want to deepen your expertise on ISO 19227?
As an approved training organization, FILAB offers you tailor-made training in chemical analysis of cleaning residues (organic HCT/COT contaminants, inorganic residues and particulate contaminants) on medical devices in light of the requirements of ISO 19227.
At FILAB, we develop and offer our clients only tailor-made 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.
There are several reasons behind the growing number of training requests at FILAB:
Des formations techniques sur-mesure : la plupart des formations proposées par de nombreux organismes de formations sont standards, non sur-mesure, et ne répondent pas à vos problématiques techniques
Des personnes hautement qualifiées : nos formateurs sont des personnes du laboratoire, docteurs ou ingénieurs spécialisés
Des connaissances industrielles : FILAB réalise des formations à ses clients depuis plus de 10 ans, quel que soit le secteur industriel
Un profil unique avec une double compétence en Chimie et en Matériaux
Une structure à taille humaine, qui nous permet une meilleure réactivité et une plus grande flexibilité
