The so-called periodic safety checks

 
The so-called periodic safety checks started on diagnostic radiology equipment in about 2001, after coming Decree No. 47/1999. of the Minister of Health (which was recently replaced by Decree No. 4/2009. of the Minister of Health) into force. It takes place under the surveillance of the Directorate of Medical Devices. This check is an explicitly safety control, serving for electrical, mechanical and radiation safety. As safety is inherently interdependent with quality, some quality aspects also were included. 27th paragraph and 13th Annex of the mentioned decree requires the safety checking, for interventional X-ray equipment annually and for all other (diagnostic) radiology equipment (except CT) bi-yearly, moreover, after major servicing. Main aim of this specific Hungarian requirement is to warrant safety of equipment many of which are not under any technical surveillance (maintenance, QC). These tests are performed by organizations, authorized – upon application – by the Directorate of Medical Devices. Checking electrical and mechanical safety remains always an important task but it is independent from QC and they must be clearly distinguished.

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