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123/148 REF C04717-02-91 Q-NRG User Manual, Edition 4.2
Appendix COSMED srl
IEC 62353 safety test
Note : These tests can be performed by competent personnel only. Competence shall include training on the
subject, knowledge, experience and acquaintance with the relevant technologies, design standards and
local regulations. The personnel assessing the safety shall be able to recognize possible consequences
and risks arising from non-conforming equipment.
IEC 62353 safety test provides a method of determining if potential health hazards to the patient or user of the
device exist.
This test shall be executed in the following cases:
• Before putting the device into service.
• After repair (if applicable, see Service Manual for further details)
• Recurrent safety tests, if planned.
Detachable power supply cord that is expected to be used with the device, shall be inspected and the protective
earth resistance shall be measured.
References
IEC 62353 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment.
Test equipment and conditions
The test equipment required to perform electrical safety tests is listed below.
• Safety Analyzer / Leakage Current Tester conforming to IEC 62353.
Refer to the instructions delivered with the safety analyzer to perform each test.
Commonly used definitions within IEC 62353 (and IEC 60601)
Equipment Under Test The equipment (EUT) which is the subject of testing.
Device Under Test
The equipment (DUT) which is the subject of testing.
Applied Part
Part of medical electrical equipment that in normal use necessarily comes into physical
contact with the patient for medical electrical equipment or a medical electrical
system to perform its function.
Patient Connection Individual point on the applied part through which current can flow between the
patient and the medical electrical equipment in normal condition or single fault
condition.
Patient Environment Any volume in which intentional or unintentional contact can occur between a patient
and parts of the medical electrical equipment or medical electrical system or between
a patient and other person touching parts of the medical electrical equipment or
medical electrical system.