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Medical device testing laboratory is accredited by the National Accreditation Agency of Ukraine for compliance with the requirements of State Standard of Ukraine (DSTU) ISO/IEC 17025:2006 (ISO/IEC 17025:2005, IDT) as part of the conformity assessment made by Ukrainian Certification Agency
Accreditation Certificate of Medical Device Testing Laboratory No. 2Н1445
The main objective of the laboratory is to ensure reliability and accuracy of measurement and product test data, compliance with the requirements of regulatory documents on test methods, rules for the use of measuring equipment, testing equipment and measurement methods, timely fulfillment of applicants’ orders in full and with minimal costs. This is achieved by implementation and continuous operation of the quality assurance system.
The quality policy of the testing laboratory is aimed at achieving and maintaining a high level of personnel qualification and organization of testing activities to ensure that all procedures are carried out objectively and reliably.
All laboratory personnel have an appropriate level of education, necessary technical knowledge and work experience in the declared field of accreditation.
The laboratory “Ukrainian Certification Agency” performs tests for the following product groups in accordance with the field of accreditation:
- medical gauze: test for foreign fibers, surface density, number of threads, dive time;
- medical gauze bandages: test for tightness of the package seam, linear dimensions and measurements;
- napkins and medical gauze squares: linear dimensions and measurements.
Phone: +38 044 223 7208
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