Knowledge and understanding on using standard document. Knowledge and understanding methodologies for risk analisys approach in particular for the electrical risk.

Basic electrotechnical principles. Hospital electrical plants.

Definition and relation between European Directives, laws and technical standards. The 93/42 Directive and the new MDR UE/2017/745. Using Standards in Acceptance test and preventive maintenance. Risks linked to the elctromedical devices, Risk management according to ISO EN 14971. Electrical current effects on human body and periodical safety checks. Patient Risk.

SERIE CEI EN 60601-1 CEI 62-93 DIRECTIVE 93/42/EEC ISO EN 14971 MDR 745/2017 COURSE NOTES

Definition and relation between European Directives, laws and technical standards. The 93/42 Directive and the new MDR MDR UE/2017/745. Using Standards in Acceptance test and preventive maintenance. Risks linked to the elctromedical devices, Risk management according to ISO EN 14971. Electrical current effects on human body and periodical safety checks. Patient Risk. Periodical electrical safety checks on electromedical systems. Periodical safety checks related to particular standards of electromedical equipment.

Lectures aid by slide and whiteboard. Electrical test with safety analyzer.

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The exam will consist of an oral test where the student will have to demonstrate that he has understood the topics proposed in the course. The evaluation of the exam will be in x/30.

This course explores topics related to one or more objectives of the 2030 Agenda for Sustainable Development.