Medical Device Testing
Medical Device Testing Laboratory
Prof. Dr. Yekta Ülgen
Research Assistants Fatma Gülden Simsek and Hakan Solmaz
|Phone: +90 212 358 15 40 / 1438|
Our Laboratory offers the following services to Health Institutions;
1. Examination of biomedical device inventories for the classification of medical equipment according to their importance and risks and detecting the priority of devices for calibration test measurements.
2. Scheduling the first prior groups (Operating Room, Radiology, Intensive Care Unit…) for the calibration test measurements.
3. Determination of the compliance of medical devices with the international standards; Emergency Care and Research Institute (ECRI) and American Advancement of Medical Instrumentation (AAMI) and radiology devices with the international standards; American College on Radiology (ACR) and American Association of Physicists in Medicine (AAPM).
4. Testing and controlling the compliance of devices, which have been repaired and calibrated by private companies by means of special testing devices.
5. Performing acceptance tests of newly purchased medical devices and controlling the devices that have been tested by the vendor company.
6. Control of compliance of electrically operated medical devices with the international standards (IEC-601 / NFPA-99) performing the Leakage Current and Electrical Safety tests.
7. Control of compliance of electrical insulations and grounding of electrical outlets in the Operating Room and Intensive Care Units with the international standards.
8. Control and test measurements of all electrical wiring and grounding of electrical outlets (NFPA-99) in the Operating Room and Intensive Care Units and amount of oil, aerosol, water vapor and carbon monoxide at the outputs of medical gas outlets for compliance with the international hospital standards (Z305.1 / HTM 2022).
9. Control and test measurements of air quality by “clean-air” particle tests in the Operating Rooms for the compliance with the international hospital standards (ISO 14644 / FED-STD-209E).