The accreditation of testing laboratories of Ukraine against DSTU ISO/IEC 17025:2019 is an integral part of the procedure for recognition of the results of the tests these laboratories carry out (International Laboratory Accreditation Cooperation (ILAC)). The accreditation of a laboratory against this standard indicates that the laboratory is capable of providing accurate, reliable and reproducible results of product testing and of fulfilling the applicant’s orders in a timely manner and in full.
The National Accreditation Agency of Ukraine confirmed the technical competence of the UNI-CERT Testing Laboratory against DSTU ISO/IEC 17025:2019 General Requirements for the Competence of Testing and Calibration Laboratories (ISO/IEC 17025:2017, IDT) with an Accreditation certificate No. 201394 dated 20 April 2021).
The laboratory’s scope of activities covers the testing of the following products:
- medical devices, namely medical gauze, gauze roller bandages, elastic medical bandages, gauze pads and gauze cuts, disposable medical gloves, single-use syringes, sterile single-use injection needles;
- in vitro diagnostic devices, namely single-use receptacles for the collection of specimens, other than blood, from humans, single-use containers for human venous blood specimen collection, single use intravascular sterile catheters, and the information compliance on the labels applied by the manufacturer;
- active implantable medical devices as related the information compliance on the labels applied by the manufacturer;
- personal protective equipment, namely masks, half masks and quarter masks;
- anti-aerosol filters, threaded connections for face pieces, filter half masks for protection against aerosols, filter half masks with valves to protect against gases or gases and aerosols, half masks without inhalation valves and with separable filters to protect against gases or gases and aerosols, or only from aerosols , filters with breathing hoses (non-mask filters): aerosol, gas mask and combined, gas and combined filters;
- safe shoes;
- protective clothing, protective gloves;
- surgical masks;
- nipple rubber and latex babies;
- walking aids operated with one hand;
- rubber condoms;
- sets and clothing for protection from the cold;
- protective clothing against infectious agents;
- protective clothing against chemicals;
- textile materials.
The Testing Laboratory provides testing for compliance with 49 international and domestic standards using 146 test methods for medical devices and personal protective equipment.
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We will be glad to answer your questions. You can contact us via the contact page