IEC60601-1 4^th edition is concerned with the intended use of a product, and it’s safe operation in the intended environment – so while it is correct that a very large amount of clinical equipment used in a hospital must fulfill the requirements for IEC60601-1 medical approval, the application itself is the determining factor, the extent of patient contact and where it is to be used.



IEC60601-1 defines the environment as either professional or home healthcare, dependent upon a number of factors such as whether trained clinicians are constantly present, and whether anyone lives on the premises. Thus it is quite clear that any and all medically certified devices, irrespective or where they might be plugged in need to meet the latest medical power supply approval standards.



In fact the EMC requirements for home use are more stringent than within the monitored environment, the thinking being that at home a medical power supply could be plugged in adjacent to a very ‘noisy’ appliance such as a microwave oven, whereas on a hospital ward all such equipment is excluded.



Potential for patient contact, safe operation under fault conditions & the intended operating environment, these are the key criteria. Therefore whether it is a power supply to move a powered bed in a hospital, or an external USB plugtop power supply in your kitchen at home, the required approvals might be the opposite way round to what is expected.

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