The characteristics of medical systems and their components must be documented comprehensively. During a PCs, high requirements and liability risks exist for the respective examiner. Controls carried out safety in most cases by medical technicians or specially trained electricians. Especially for medical technology, a high risk for patients and users is malfunction. In addition, be many rules and laws, which applies it to comply. For these reasons, training, knowledge and practical experience in the field of medical technology be provided controller.
The end of the test person may be subject to any authority. That means she are completely independent and must be not be affect by the contracting authority. Furthermore, the examiner in the possession of the necessary test and measurement must be, which must comply with the current state of the art. The safety begins with the inspection control. While it’s an outwardly perfect condition.
Damages, deformations, imperfections but also pollution, bonding or wear represent a deviation from the ideal State. Should these be identified, an internal Visual inspection or the communication to the operators of the affected medical device is first. A Visual inspection sounds while on the surface, however, includes Visual scrutiny of the following inventory and components: Housing body parts display devices inscriptions short operating instructions checklists labeling or designation of the body parts accessories and wear parts instruction manual, if necessary added safety information and instruction for maintenance medical product book presence of CE-marking according to MPG general warnings (in English or in the language of the user) fuse-links (according to manufacturer’s instructions) power cord extension cords, multi-plugs software version is completeness and good condition of Earth potential balancing cable and connectors for controlling the functioning of medical technology (combinations with PCs) assuming the presence of the instruction manual.