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 8.6: Protective earthing, functional earthing and potential equalization of ME equipment

What does 8.6 require?

Unless the parts meet IEC 60950-1 protective earthing and serve only as operator protection: the protective earth terminal suits connection by the cord's earth conductor and plug or by a fixed conductor, its clamping means meets 8.11.4.3 and needs a tool to loosen, screws making internal earth connections are covered or otherwise kept from being loosened from outside, the earth pin of an appliance inlet is the protective earth terminal, and the terminal is not used to hold parts together or fix unrelated components; a protective earth connection is not used for a moving part unless shown reliable across the service life; connections carry fault current without excessive voltage drop, the impedance not exceeding 100 milliohms from the terminal or inlet earth pin, or 200 milliohms from the mains plug pin of a non-detachable cord or of a supplied or specified detachable cord (a 3 m cord of appropriate cross-section where none is specified), tested with the larger of 25 A and one and a half times the highest rated current, at 50 or 60 Hz or d.c. from a source of no more than 6 V no-load for 5 to 10 s, with a two-step method where the product would exceed 6 V, higher impedance being allowed where limited current keeps touch and patient leakage within single fault limits; poorly conducting coatings are removed at earth contact points unless the joint construction and process assure impedance and current capacity; plug-and-socket connections operable by non-service persons make the earth before and break it after the supply; a potential equalisation terminal is accessible in every normal-use position, resists accidental disconnection, detaches without a tool, is not used for protective earth, carries the equalisation symbol and is explained in the instructions, with no equalisation conductor in the power cord; a functional earth terminal is never a protective earth; and where class II equipment has internal screens that are isolated and is supplied with a three-conductor cord, it uses the third conductor only as a green-and-yellow functional earth stated as such in the documents, with two means of protection between the screens and accessible parts explained in the technical description.

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

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