Training in ISO 19227 analysis for laboratories

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:

1. 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.
2. The design of a cleaning process based on the characteristics of the implant, its expected performance and its manufacturing steps.
3. Definition of minimum cleanliness criteria after final cleaning
4. Validation of cleaning methods for each type of implant
5. 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.