IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 4 to 5: general requirements and testing – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 5.4: Other conditions

What does 5.4 require?

Unless a clause specifies otherwise, equipment is tested in whichever working conditions, among those the instructions for use allow and the risk analysis flags, are least favourable, and those conditions are recorded for each test they affect; operating values adjustable by anyone other than service personnel are set to the least favourable values within the instructions; tests influenced by cooling liquid pressure, flow or composition are run within the technical description's limits; and potable water is used where cooling water is required.

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