Analysis of heavy metal residues according to ISO 19227

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 (, according to validated and documented methods, helping you to comply with the requirements of the ISO 19227 standard.

To go further

  • Search for traces in a cleaning product (detergent, oil, lubricant...) 

  • Inorganic contamination analysis by ICP-MS and CLI

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The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Eve BALEY Technical Sales Representative
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+33 (0)3 80 52 32 05 Request
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