Actors of the Medical Devices sector, you wish to analyze the heavy metal residues on your products
What is the 19227 standard?
The international standard ISO 19227 with the name “Surgical implants – Cleanliness of orthopaedic implants – General requirements“, describes the requirements for the cleanliness of orthopaedic implants as well as the validation of the cleaning processes used.
The objective of cleaning validation via ISO 19227:2018 is to verify the effectiveness of the cleaning process in reducing physical, chemical and microbiological contaminants below a customer-defined level.
Why analyze heavy metals according to the 19227 standard?
Although some are essential to industry (lead, chromium, etc.), other heavy metals have a particular toxicological profile (mercury, titanium, etc.).
Thus, their use is strongly regulated in the medical devices sector.
Therefore, the analysis of heavy metals according to the 19227 standard, allows to check the conformity of your medical devices and to put them on the market.
FILAB supports you in the analysis of heavy metals according to the 19227 standard
FILAB laboratory offers a wide range of services, some of which are COFRAC ISO 17025 accredited (www.cofrac.fr), according to validated and documented methods, helping you to comply with the requirements of the ISO 19227 standard.
To go further
Analysis of organic contaminations by TOC meter, GCMS, LCMS
Surface analysis by SEM-FEG or Optical Microscope
Search for traces in a cleaning product (detergent, oil, lubricant...)
Inorganic contamination analysis by ICP-MS and CLI
