📍Atatürk Bulvarı No: 72/16, İkitelli, Başakşehir / İstanbul
We verify that bedside medical devices operate safely and accurately through performance tests based on international standards. Brand- and model-independent, with nationwide on-site service.
Medical devices wear over time; their sensors drift and the values they report may diverge from reality. Even a deviation of a few units in the gas volume delivered by an anesthesia machine, the pressure applied by a ventilator, or the energy discharged by a defibrillator can directly put patient safety at risk.
Our Testing Laboratory measures the physical quantities produced by devices (volume, pressure, flow, oxygen concentration, energy, etc.) using reference test equipment and verifies whether they remain within the limits declared by the manufacturer and required by the relevant standard.
All tests are carried out under the 25 June 2015 “Regulation on the Testing, Control and Calibration of Medical Devices”, with TS EN ISO/IEC 17025 testing infrastructure and our certified expert team. Your device is evaluated regardless of its brand.
Each device group is evaluated according to its specific international standards by measuring the relevant physical quantities.
The gas parameters and safety functions delivered by anesthesia workstations to the patient circuit are verified.
Relevant Standards
TS EN ISO 80601-2-13 / -12 / -55
The pressure, volume and timing parameters delivered by intensive-care and respiratory-support ventilators are tested.
Relevant Standards
TS EN ISO 80601-2-12
The vacuum (negative pressure) level and flow performance generated by medical suction units are verified.
Relevant Standards
TS EN ISO 10079-1 / -3
The energy output and signal-reading functions of defibrillators are tested by comparison against the selected values.
Relevant Standards
TS EN 60601-2-4
Our laboratory is authorized in the following quantity and function groups for medical device testing.
Verification of patient monitor and physiological parameter reading functions.
Testing of respiratory-support devices such as anesthesia machines, ventilators and suction units.
Verification of fundamental physical quantities measured against reference equipment.
Output power and safety functions of electrosurgical (cautery) devices.
Energy and signal tests of defibrillators and electrotherapy devices.
There is no need to ship your devices off-premises. Our expert team comes to your healthcare facility with portable reference test equipment and performs the tests on-site with minimal disruption to clinical workflow.
From request to reporting, every step follows a traceable, standards-based workflow.
Device inventory is collected via the Test Request Form; the site visit and test schedule are planned.
Traceable, calibrated reference test equipment is prepared according to the test conditions.
The quantities produced by the device (volume, pressure, flow, energy, etc.) are measured at the points defined in the standard.
Results are evaluated according to the decision rule; a conformity/non-conformity decision is made.
Results are documented as a test report; the traceable record is delivered to your institution.
Tests are carried out according to the current TS EN ISO/IEC standards specific to each device group.
Decision Rule: Conformity assessment is performed according to our decision-rule instruction, which takes measurement uncertainty into account.
To start the testing process you can fill in the request form, and review the scope of our services in the presentation profile.
DOCX · Form to initiate a test request
DOCX · Service scope and details
All forms and documents are available on the Documents page.
Share your inventory and we will prepare a tailored proposal covering the on-site schedule, scope and pricing. All our services are brand- and model-independent.
1997
Experience since founding
AB-0769
TÜRKAK accreditation no.
On-site
Nationwide field service