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Ethylene oxide gas (EO) is a flammable and colorless gas commonly used in medical device sterilization. Its permitted maximum residual levels are set by a range of international and local organizations, including the International Organization for Standardization (i.e., ISO 10993-7:2008) and Japanese Industrial Standards (i.e., JIS T 0993-7:2012).   1.Biological Effect: Physical and/or Chemical information […]

  PYROGENICITY is the ability of a chemical agent or other substance to produce a febrile response.Pyrogenic responses may be material-mediated, endotoxin-mediated, or mediated by other substances.In accordance with the ISO 10993-11 we commonly conduct two test types:LAL (Limus Amebocyte Lisate) test to detected endotoxin-specific factors,Material-mediated pyrogenicity test (Rabbit Pyrogen Test) which has a wide […]

An important part of the products we handle are medical devices, that come to contact with blood (blood paths, circulating blood). For such devices, a dedicated group of tests needs to be performed, described in 10993-4, called hemocompatibility tests. This part of the biocompatibility evaluation process consists of many different parts, among which the most […]

One of the most interesting studies carried out in our laboratory are genotoxicity studies, carried out according to ISO 10993-3 and 10993-33. We conduct genotoxicity with both prokaryotic (bacterial strains – AMES method) and eukaryotic test systems (mammalian cell lines – Mouse Lymphoma Assay). Genotoxicity testing applies to various kinds of medical devices, ranging from […]

By the decision of the Polish Accreditation Center (PCA), we obtained ISO 17025 accreditation! From this moment, European Biomedical Institute is ISO 17025 accredited with the accreditation number AB 1763. The main purpose of implementing the ISO 17025 system is to improve the quality of tests and measurements performed. The requirements of the ISO 17025 […]

ISO 10993-23:2021 Biological evaluation of medical devices – Part 23: Tests for irritation. The long-awaited ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation has been finally published!   Irritation tests of medical devices were taken out from ISO 10993-10, and now are fully described in dedicated ISO 10993-23 – many […]

We are heappy to annouce that the Walletmor payment implant has successfully passed cytotoxic testing. Check more!