Do you want to train your teams in the analysis of cleaning residues on medical devices according to the ISO 19227 standard?
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 07.10.2024
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.
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.
Do your teams need training in the analysis of cleaning residues on medical devices in accordance with the standard ISO 19227?
What is the ISO 19227 standard?
The international standard ISO 19227, published under the name “Surgical implants – Cleanliness of orthopaedic implants – General requirements”, describes the requirements for the cleanliness of orthopaedic implants and the validation of the cleaning processes used.
The implementation of ISO 19227 requires several complex steps to be carried out upstream by Medical Device companies:
- A complete review of the cleaning risk analysis. Risk management is an iterative process that must be conducted by the customer throughout the design, validation and use of the cleaning process.
- The design of a cleaning process based on the characteristics of the implant, its expected performance and its manufacturing steps.
- Definition of minimum cleanliness criteria after final cleaning
- Validation of cleaning methods for each type of implant
- Biological evaluation according to ISO 10993-1 and validation of the sterilization process
In this process, FILAB laboratory assists companies in the chemical analysis of cleaning residues (organic HCT/COT contaminants, inorganic and acidic residues, particulate contaminants) on medical devices.
FILAB's ISO 19227 training...
Do you want to perform a cleaning residue analysis on your DM? The competent person(s) are no longer part of your team? Would you like to improve your expertise on the ISO 19227 standard?
As an accredited training organization, FILAB offers customized training for the chemical analysis of cleaning residues (organic HCT/COT contaminants, inorganic residues and particulate contaminants) on medical devices in accordance with the requirements of the ISO 19227 standard.
At FILAB, we develop and offer our clients 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.
