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 EN ISO/IEC 17025:2019 (EN ISO/IEC 17025:2017, IDT; ISO/IEC 17025:2017, IDT) with an Accreditation certificate No. 201394 dated 31 Marсh 2022).
The laboratory’s scope of activities covers the testing of the following products:
Physico-mechanical and chemical tests of inactive medical products, namely: medical gauze bandages, medical gauze, napkins and pieces of medical gauze, disposable medical gloves, disposable injection syringes, sterile disposable injection needles; rubber and latex children’s nipples; walking aids controlled by one hand; rubber condoms, as well as their marking; physical tests and verification of labeling of medical products for in vitro laboratory diagnostics, namely: single-use collections and containers, intravascular catheters; personal protective equipment: shoes, masks, half masks, quarter masks and filters, clothes and gloves; checking the labeling of active implantable medical devices.
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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