Quality Management

Quality ManagementOur steam sterilizers are the first devices in Turkey holding the standards of ISO and CE mark. Our products, which are certified as required by our quality management system, are used in the public and private organizations in the health sector.

Trans by Getinge designs its sterilizer devices in its own production facilities and carries out the mechanical, electrical and electronic production processes on site, in its own production facilities.

The production of our devices is conducted using standard configurations. Upon request by organizations, additional equipment can be added to the standard configuration.

 

QUALITY CONTROL

Quality Control Unit works depend on our Quality Management System gives factory approval. Product shipping can only be done after this approval. Quality Control Unit applies the tests below and gives permission for shipping only if positive results are taken.

  • Air – Leakage
  • Bowie-Dick
  • ETS
  • Helix
  • Chemical Indicators
  • Biological Indicators

 

QUALITY CONTROL SYSTEM
  • We are certified in CE marking under the Quality Management System Medical Devices Directive (93/42/EEC) according to ISO 9001 and ISO 13485and in CE marking under Pressure Vessel Directive (97/23/EEC) by the notified certification bodies like Meyer and Turkish Standards Institution.
  • Our products are used in central sterilization units at hospital and clinical applications.
  • Quality testing and inspections are indispensable elements of our Quality Management System.
  • Products are manufactured with minimum maintenance costs by the careful selection of equipment and using advanced design technology.
  • Our modern technology provides ease of management and monitoring of products.
  • Sterilizer boiler, jackets and the doors are produced with high quality, 316L or 316 Ti stainless steel materials.
  • Sterilizer boiler and steam generator are designed according to the special quality design standards and approved according to Pressure Equipment Directive by Turkish Standards Institution.
  • Sensors on the devices are calibrated before installation and are delivered ready to use.
LIGHT, NOISE AND WEIGHT CONTROLS

User may get actual informations about the working conditions of device like noise level, light intensity and material weight. The following devices are used to make measurements on Sterilizers physical work environments.


Weighing


Noise level meter


Light intensity meter