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IEC-60601 has evolved since first being published almost 40 years ago. Because power supplies and DC/DC modules are not medical devices, the safety standards do not apply to them directly. However, medical device manufacturers would not be able to achieve medical standard compliance without power solutions that have been designed for medical applications. Medical devices must incorporate a Means of Protection (MOP) to ensure that both the patient, if connected via an Applied Part, and operator are protected from the risks of electric shock, even under fault conditions. Per the standard, operators and patients are treated differently, resulting in the classifications ‘Means of Operator Protection’ (MOOP) and ‘Means of Patient Protection’ (MOPP). One of the key safety concerns with respect to medical devices is that the patient is often electrically connected to the device. In IEC-60601 these are defined as ‘Applied Parts’ (AP) and are an important definition within the standard when defining a medical product’s overall requirements. Because of this risk, the 2xMOPP requirement is the more stringent, requiring a minimum of 4000VAC isolation voltage, 8mm creepage distance, and a double or reinforced insulation level.

PTM Published on: 2018-08-31