Medical device connector specification

Medical device connectors only need to meet the 2Mopp specification.

Medical devices used to diagnose, treat, and monitor patients, such as electrocardiograms (Ecgs), thermal cautery, and monitors, must meet extremely high safety requirements. The international standard IEC 60601-1 directs product designers to address key issues, including protection against electric shock, thermal and mechanical stress, risk management and other considerations.

Whether the medical product is for medical or mobile applications, including in the patient's home, reliable and robust components are essential prerequisites for performance and longevity. IEC 60601-1 requires manufacturers of medical electrical equipment and systems to ensure the high level of safety of their products. In particular, the standard requires connectors and other components to handle the transmission of power, data, and signals to protect the medical device from other damage from electrical shock when it comes into contact with the patient or operator.

safety

Today, high-performance medical electrical equipment is found in virtually every healthcare environment, and because these products are often connected to a 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, which can trigger heart irritation. In addition, lightning strikes can cause the cable transient voltage to be too high. Therefore, the electrical equipment and systems used in the medical sector must be well protected.

The technical requirements described in IEC 60601-1 are almost always related to the protection during shocks. In order to minimize the risk of electric shock, the standards for medical electrical equipment and systems specify the means of protection (MOP). They are subdivided into two categories: patient protection (MOPP) and operator protection (MOOP). Protection means the general precautions taken to protect people from harm when they are exposed to medical equipment. IEC 60601-1 requires two protective measures (2 Mopp and 2 MOOP), including patients and operators, and electrical medical equipment and systems are also compliant with standards to ensure that if one of the protective measures fails, the other is effective. An effective way to achieve this is to double the gap and leakage distance between the conductors.

Because patients are often weaker than medical staff and may not be able to respond (for example, if they are under anesthesia), they must be particularly well protected. Therefore, the requirements for patient protection measures are even more stringent than those for health workers. Therefore, connectors designed for use in devices that are in contact with the patient, or accidental contact with the patient's connector, require greater clearance and creepage distance, greater insulation, and reduced leakage current to meet the 2 Mopp specification. For medical electrical equipment and systems that are not in the patient's environment, it is sufficient to meet the medical staff's protective measures (2 MOOP).

Type C to 3.5mm Audio Headphone Stereo Adapter

 

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Post time: Mar-15-2019
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