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Training in ISO 19227 analysis for laboratories
Do you want to train your teams in the analysis of cleaning residues on medical devices according to the ISO 19227 standard?
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.
Why train to ISO 19227?
Validation of the exhaustiveness of the extraction method
Analysis of mineral acid residues by CLI
Measurement of Total Organic Carbon (TOC) by TOC meter
Analysis of heavy metal residues by ICP
Analysis of leachate residues by ICP
Analysis of total hydrocarbon residues (HCT) by GC-FID
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.
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²