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Analysis of medical devices

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Our laboratory offers a number of tests that are necessary for checking the quality/safety of medical devises.

Our capabilities include the following tests:

  • Testing  the content of harmful substances (organic substances and metals) in extracts

(Methodological instructions on toxicological and hygienic researches of polymeric materials and products based on their medical purpose, Kiev, 2004,

ISO 10993-13 Biological evaluation of medical products. Part 13. Qualitative and quantitative analysis of degradation products of polymeric medical products

  • Residues after sterilization with ethylene oxide (ISO 10993-7 Biological evaluation of medical products – Part 7. Residues after sterilization with ethylene oxide products.
  • Control of invisible particles by the light obscuration particle count test ( Ph.Eur 2.9.19, USP <788>)
  • Sterility (Test of Sterility) (Ph.Eur 2.6.1, USP <71>, ISO 11737-2: 2015)
  • Microbial Bioburden test (Ph.Eur 2.6.12, USP <61>, ISO 11737-1: 2006)
  • Bacterial endotoxins (gel-thrombus test) (Ph.Eur 2.6.14, USP <85>, <161>)

To contact the experts use the information in the “Contacts” section.

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