With DICTATOR interlock control systems, Inomed meets the quality standards of ISO 13485 for medical device manufacturers
The company Inomed in Emmendingen (Germany) produces medical systems for all surgical areas for the protection and therapy of neurological functions. It goes without saying that these products must be manufactured under clean room conditions.
When certifying a quality management system according to ISO 13485 for manufacturers of medical devices, technical precautions must also be taken for small interlocks such as this one, which exclude human error and thus ensure quality in every case – even if it can normally be assumed that the employees themselves are compliant with the regulations.
In this case, the interlock already existed. For Inomed it was important to have an easily retrofittable interlock control system that could be installed and programmed by the company who takes care of all of Inomed’s electrical matters.
In the interlock and the clean room situated behind it a pressure measuring ensure that the pressure in the clean room is higher than in the interlock and that the pressure in the “unclean” corridor in front of it is also higher. This prevents impure air from entering the clean area.
Complete interlock system from one provider
After the required interlock functions and the necessary components had been determined, DICTATOR supplied the interlock terminals for both sides of the doors complete with the pluggable connection cables, power pack, distribution box, bar magnets and mounting accessories as surface boxes for the terminals and brackets for the bar magnets.
Connecting the interlock control system to the pressure compensation measuring system on site was no problem, so that in the event of a pressure drop in the clean room or in the corridor to the unclean exterior area the interlock control system prevents the opening of the respective door.