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Testing Laboratory "SRC for Assessing Compliance with Safety Indicators for Medical Products"

Testing laboratory "Research center for assessing compliance with safety indicators of medical products PE "POLITOKS" within the framework of the agreement on scientific and technical cooperation with the testing laboratory" Department of Polymers of Medical Applications "of the Institute of Macromolecular Chemistry of the National Academy of Sciences of Ukraine, accredited by NAAU in accordance with the requirements of DSTU ISO / IEC 17025: 2017 (Accreditation Certificate No. 20725 dated 03.05.2019) performs tests in accordance with international standards DSTU EN ISO 10993-1: 2015, DSTU EN ISO 10993-4: 2015, DSTU EN ISO 10993-5: 2015, DSTU ISO 10993-10: 2004, DSTU EN ISO 10993-11: 2015.

The results of the biocompatibility assessment and the sanitary-chemical analysis make it possible to carry out the full volume of tests for medical products in accordance with the requirements of international standards.

Biomedical Testing. Testing Laboratory

The testing laboratory "Research center for the assessment of compliance with safety indicators for medical devices" within its scope of accreditation carries out medical-biological tests of medical products, medical products for diagnosis in vitro, active implantable medical products, sanitary and hygienic products, polymeric materials, and products based on their medical purpose, cotton gauze products, rubber and latex products of medical purpose, medical metal instruments, medical devices and their warehouse and so on.

The testing laboratory is equipped with an analyzer of heavy metals M-XA 1000-5 and conducts studies on the content of heavy metals in drinking water and other products of the food industry.

Full Certificate Document