testing of medical devices Turkey

...The safety of your electrically powered medical devices has become a significant concern for organizations manufacturing electrical medical devices, as the IEC 60601-1 standard identifies various risks associated with medical devices. As Türcert certification body, we provide consultancy for medical testing to ensure compliance with this standard. We also offer consultancy services for test reports in your technical files during the approval stages of the European and U.S. Food and Drug Administration (FDA).

... Leak Test Devices can monitor the test at a level of 0.1 Pa, capturing even very low pressure differences and providing you with measurement precision. It is suitable for automation and can manage the system it is part of. By being able to manage the system, it eliminates the need for an operator. It is suitable for mass production lines as it shortens the testing time, allowing more products to be tested throughout the day. It can operate within a measurement range of -1 to +40 Bar. The advanced leak test devices produced by Adlema also offer reporting features.

... results, which can be ensured by complying with international standards. Calibration means reporting the results of a measurement device whose accuracy is uncertain by comparing it with another measurement device whose accuracy is assured and traceability is established. In order to determine that the medical devices in a laboratory or any medical institution are operational and measuring accurately, they must be calibrated. For this purpose, the operational control, testing, and maintenance intervals of these devices should be established.

... easy loading, unloading, let to clean the chamber by forced air circulation after the post-operation and pass-through option for cleanroom operations. To eliminate pressure risk, security lock jaws have been installed on the sterilizer’s door. The inflatable silicone gasket eliminates risks of gas leakage which occurs by air pressure. System testing for gas leakage under vacuum conditions per each cycle provides full security. Devices are long-lasting thanks to their stainless steel structure. Axis Industrial Type of Ethylene Oxide Sterilizers can work under negative and positive pressures.

...The LVD test for Eurolab is the technical core component of the institution's working committees on European standards. - Committee CT62 for medical devices, - Committee CT59 for instruments, - Committee CT34 for lighting fixtures, - And many others. Eurolab (conducts tests within the framework of safety inspections related to all its laboratories and associated laboratory tests, both...

... become a necessity. Some of the product groups that receive testing and certification services in the EMC laboratory include: - Electrical Household Appliances - Electrical Commercial Equipment - Lighting Fixtures - Professional and Industrial Devices - Measurement and Control Equipment - Medical Devices EMC has separation systems that comply with the standards applied in its respective areas. These standards are recognized worldwide. Civil standards are designed for military products.