Device Compliance Tests

Device Compliance Tests

The principles of the Machinery Safety Regulation issued by the Ministry of Industry and Trade include the following devices covered by the Regulation on Electrical Equipment Designed for Use within Certain Voltage Limits (2006 / 95 / AT): household appliances, audio and video intended for use in homes. devices, basic office machines, information technology devices, low voltage switches and control panels and electric motors, high voltage electrical equipment switches and control devices and various types of transformers.

All these devices and machines, which are properly established, maintained and used for the purpose they are manufactured in accordance with the principles of the Regulation, should not harm human health and safety and goods while working.

In addition to these devices, medical devices are also subject to conformity checks. In this context, physical and physicochemical tests of medical devices (such as volume, size, dropper and similar scale control, acidity-alkalinity determination, conductivity, flow rate, non-permeability, tightness and surface tension tests) and mechanical tests (eg breaking strength, separation adhesion strength, compressive strength, tensile strength and bending strength tests).

Manufacturer companies must apply one of the conformity assessment procedures specified in the regulation in order to certify the suitability of the devices.

In the scope of device compatibility tests, analytical performance evaluation of various measuring devices used for medical purposes, tests related to heart stents, tests on implant materials, tests on surgical thread and needles and many more tests are performed.

During the conformity test studies, current legal regulations and related standards published by many domestic and foreign organizations are taken into consideration. In accordance with the needs of enterprises, our company conducts device conformity tests within the framework of conformity tests.

In the meantime, our company complies with the TS EN ISO / IEC 17025 Standard for the Adequacy of Testing and Calibration Laboratories. From ÖSAS Accreditation Agency has been accredited and serves within this framework.