IEC 60601-1 - Medical Electrical Equipment Safety
Clause 8: protection against electrical hazards – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 8.2: Requirements related to power sources

What does 8.2 require?

Equipment specified for use with a separate, non-mains power source either treats the source as part of the equipment, with all relevant requirements applying, or the combination is an ME system, checked by inspection and by testing connected to the particular supply or by inspecting the specification of a generic one; and equipment specified for an external d.c. source is designed so that reversed polarity does not lead to the hazardous situations of 13.1 and the equipment maintains basic safety and essential performance once connected correctly, tool-free resettable protective devices being acceptable if they restore normal condition; checked by inspection and functional tests.

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