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IEC 60601-1 - Risk assessment to determine the liquid - 11.6.3

Tiago Alfenas

Starting to get Involved
The equipment uses deionized water for cooling, we had not considered, but now let's consider, the question is how to determine the test to be done? volume, height?



Staff member
Super Moderator
The standard lays out the testing:

A quantity of liquid is poured steadily on a point on the top of the ME EQUIPMENT. The type of liquid, volume, duration of the spill, and
location (point) are determined through analysis. Test conditions that simulate the worst case for spillage shall be documented in the RISK

After these PROCEDURES, the ME EQUIPMENT is to pass the appropriate dielectric strength and LEAKAGE CURRENT tests and is to show no signs of wetting of uninsulated electrical parts or electrical insulation of parts that could result in the loss of BASIC SAFETY or ESSENTIAL PERFORMANCE in NORMAL CONDITION or in combination with a SINGLE FAULT CONDITION (based on a visual inspection).

You have to determine volume, duration, height based on your assessment of worst case conditions.
If you have a closed loop cooling system then your risk may be limited to leakage issues rather than spillage.
Unless, say, the user has to 'top-up' a reservoir? Spillage may occur then.
So, hazard = spillage of top-up fluid
possible severity to be tested - 5 litres deionised water from a jug 1 metre above unit (just a guess!)
probability - only done during commissioning, so once per units lifespan

Result - is Basic Safety or Essential Performance affected?
Doe the unit still pass the dielectric strength and leakage current tests of clause 8?
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