TECHNICAL TESTING LABORATORY

The laboratory for technical testing of medical devices was created on the basis of IMPROVE MEDICAL LLC.

IMPROVE MEDICAL laboratory is the only technical testing laboratory in Ukraine that can test medical devices used in modern interventional cardiology and cardiac surgery. Drawing on our in-depth knowledge of cardiovascular fluid dynamics, understanding of mechanical and biological prosthetic heart valve testing requirements, and regulatory frameworks, our team is able to assess the hydrodynamic performance of surgical heart valve prostheses and test their strength in accordance with ISO 5840 requirements. -2: 2015.
In addition, the IMPROVE MEDICAL laboratory team has extensive experience in testing modern transcatheter aortic and mitral valve prostheses for compliance with the requirements of ISO 5840-3: 2015.

List of product range tested by the laboratory:

– Parts and devices for the production of medical devices
  CERTIFICATE No. 2H1388 (June 1, 2016)

– Appearance check. Checking labelling, packaging.
– Checking structural elements and their dimensions.
– Tests for vibration resistance, vibration strength.
– Impact tests: impact resistance.
– Bending resistance tests.
– Leak test.
– Measurement of the electrical resistance of a conductive wire.
– Measurement of electrical insulation resistance
– Test with AC voltage and DC voltage.
– Test for the effect of increased operating temperature of the environment.
– Test for the effect of reduced operating temperature of the environment.
– Tests for exposure to high humidity.
– Testing products for resistance to special environments.
– Determination of resistance to pre-sterilization cleaning, disinfection, sterilization.

32300 UKRAINE
Khmelnitsky region
Kamyanets-Podolsky
st. Khmelnytsky highway, 38
E-mail: lab@improvemed.space

Slabinskaya Maria Dmitrievna

Head of the Laboratory of Technical Tests LLC “Improve Medical”
tel: +380 96 578 95 46

tel +38044 355 50 30

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