Maintenance

The following document on Good Practice in the maintenance of medical devices describes the specific measures that hospitals can take to organise medical device maintenance in conformity with the existing legal requirements.
Standard SN EN 62353 details the requirements of the Medical Devices Ordinance as regards the maintenance of medical electrical equipment and is applicable to the entities responsible for maintenance, for example in hospitals.

 

Hypothermia devices (heater cooler units)

08.02.2017
We would like to inform you about new directives on the operation and the surveillance of hypothermia devices (Heater-Cooler Devices / Units) in the operation room:

Link to the information from the FOPH (in German):
https://www.swissmedic.ch/content/swissmedic/en/home/medical-devices/reprocessing---maintenance/maintenance.html