Testing of the product characteristics

The National Accreditation Agency of Ukraine confirmed the technical competence of the UNI-CERT Testing Laboratory against DSTU ISO/IEC 17025:2017 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.

Select test types

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Other services

Information services

The Ukrainian Scientific Institute of Certification provides information services exclusively within its competence related to medical devices, personal protective equipment and certification of quality management systems. Thanks to the experience of cooperation with the largest suppliers and manufacturers on the Ukrainian market, concluded agreements on the recognition of the conformity assessment results with leading European […]

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Education and training

The main specialization of the UNI-CERT Training Center is the advanced training of quality managers and regulatory managers of suppliers, distributors, manufacturers of medical devices and personal protective equipment. In addition, regular internal training of our own employees is carried out. In addition to the main topics that are in constant demand among most market […]

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Conformity assessment of personal protective equipment

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