How to Improve the Safety of Medical Device Connectors

Controlling leakage and creepage distances is one of the keys to designing medical equipment that reduces the risk to medical devices and systems. Medical devices used to diagnose, treat and monitor patients, such as electrocardiograms (Ecgs), thermal cauterizers and monitors, must meet extremely high safety requirements. The international standard IEC 60601-1 guides product designers on key issues including protection against electric shock, resistance to thermal and mechanical stress, risk management and other considerations. Whether medical products are used in healthcare facilities or mobile applications, including in the patient's home, reliable and robust components are essential prerequisites for ensuring performance and longevity.IEC 60601-1 requires manufacturers of medical electrical equipment and systems to ensure a high level of safety for their products. Specifically, the standard requires that connectors and other components handle the transmission of power, data and signals in order to provide protection from electric shock and other injuries when medical equipment comes into contact with a patient or operator. SafetyToday, high-performance medical electrical equipment is found in virtually every healthcare environment, and because these products are often connected to the public power supply network, they pose a potential risk to patients and operators. In these networks, power is transmitted in the voltage range of 230 V to 250 V and at an AC frequency of 50 Hz, capable of triggering cardiac stimulation. In addition, lightning strikes may cause transient voltage overloads in the cables. Therefore, electrical equipment and systems used in the medical sector must be well protected.The technical requirements described in IEC 60601-1 are almost exclusively related to protection in the event of an electric shock.In order to minimize the risk in the event of an electric shock, the standards for medical electrical equipment and systems specify means of protection (MOPs). They are subdivided into two categories: means of protection for the patient (MOPP) and means of protection for the operator (MOOP). Means of protection are general precautions taken to protect people from injury in the event of an electrical shock when in contact with medical equipment.IEC60601-1 requires that both means of protection (2 Mopp and 2 MOOP), including patient and operator, electrical medical equipment and systems comply with the standard at the same time to ensure that, if one of the means of protection fails, the other can be effective. One effective way to accomplish this is to double the clearance and leakage distance between conductors. Since patients are often weaker than medical personnel and may not be able to react (e.g., if they are under anesthesia), they must be particularly well protected. The requirements for patient protection measures are therefore even more stringent than for the protection of medical staff. Consequently, connectors designed for use in equipment that comes into contact with patients, or that incidentally comes into contact with patients, require greater clearances and creepage distances, stronger insulation and reduced leakage currents in order to meet the 2 Mopp specification. For medical electrical equipment and systems that are not in a patient environment, meeting medical personnel protection measures (2 MOOP) is sufficient.

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