Our laboratory supports R&D's development of innovative medical devices and examines their biocompatibility.
Introduction
In accordance with the ISO 10993 standard, medical devices must pass a series of tests on biocompatibility, i. e. biological assessment.
Our laboratory was created in order to satisfy the need for these tests, which are required for certification of medical devices, developed by the Research and Development department.
In the course of the first studies we conducted we have found that the Laboratory has great potential for development and can successfully expand its activity to support the Research and Development Department with expertise and equipment.
Currently, our laboratory conducts in vitro studies in the field of biomedicine and molecular biology.
Achievements
Currently, we carry out most of the in vitro tests required by the ISO 10993 standard for certification of medical products.
We cooperate with the best research centres in Poland. With professionals and laboratory equipment we are able to realize very complicated projects.
Technologies and equipment
In the laboratory we have equipment that allows us to carry out in vitro tests in the fields of biomedicine and molecular biology.
-
Technologies
Molecular biology techniques, human cell cultures (normal and tumor), animal cell cultures, UV-Vis spectrophotometry, microscopy.
-
Tests
Cytotoxicity, genotoxicity, irritation, immunoassay, pH measurement, bacterial endotoxin concentration, detection of Mycoplasma sp DNA, other tests.
-
Equipment
Laminar flow cabinets (BSL-2), analytical balances, UV-Vis spectrophotometer, microplate reader, autoclaves, pH meter, light microscopes (with cameras), magnetic stirrer, vortex, cell culture incubator, thermoblock, dynamometer with a movable base, water baths
-
Projects
Development of new medical devices or testing pre-existing products. Testing biocompatibility of medical devices for their certification. We participate in academic researches, usually basic research projects.
Scientific collaboration
We collaborate with the best research units in Poland. Our potential in the form of human resources and laboratory equipment allows us to implement projects that are very complex and even seemingly impossible to do.
Leading National Research Center
Military Institute of Medicine
Military Institute of Hygiene and Epidemiology
Warsaw University of Technology
Warsaw University of Technology
Warsaw University of Technology
A further development of the Laboratory is planned, so that we can perform full scope of tests of biological evaluation of medical devices required by the ISO 10993 standard in-house.
The full scope of research includes:
- cytotoxicity,
- sensitization,
- irritation/intradermal reactivity,
- acute toxicity,
- subacute toxicity,
- genotoxicity,
- implantation,
- hemocompatibility