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Medical device Connectors and cables Electrical safety specifications to be followed on medical devices

Medical equipment is mainly divided into three categories: diagnostic equipment, treatment equipment and auxiliary equipment

Medical connectors and wires and cables are mainly used in:
Diagnostic equipment: X-ray diagnostic equipment, ultrasonic diagnostic equipment, functional examination equipment, endoscope examination equipment, nuclear medicine equipment, experimental diagnostic equipment and pathological diagnostic equipment.
Radiotherapy equipment, radiotherapy equipment, physical and chemical equipment, laser equipment, first aid equipment and other treatment equipment.
Auxiliary equipment in the central suction and oxygen supply system, medical data processing equipment, medical video photography equipment, etc.

The application of medical connectors and cables  in medical equipment shall meet the general safety requirements of medical electrical equipment and the safety requirements of medical electrical systems, and shall conform to the structural requirements of components and components in national standards and IEC standards (GB 9706.15-2008/IEC60601-1-1:2000) :
I. Protection against danger of electric shock:
1. Enclosure: A part of a non-medical electrical device in the patient's environment that may be touched by the operator or patient and whose operating voltage does not exceed 25V ac, DC or peak 60V.
2. Shell leakage current and patient leakage current: The accessible leakage current of the outer coating in the equipment is considered as the shell leakage current. Under normal conditions, the leakage current of the shell from the system or between system components in the patient environment should not exceed 0.1mA, and the leakage current of the patient in CF applications should not exceed 0.5mA.
3. Connection of the signal input or output parts: Medical connectors and wiring harness cables shall be grounded, and isolating devices shall be used if specified equipment is not connected to the common protective grounding of the system.

Ⅱ. Structural Requirements:
1. Connections: Electrical, hydraulic, pneumatic and gas connections and connectors shall be designed and manufactured to prevent improper connections of accessible connectors and safety hazards arising from disassembly without the use of tools.Unless it can be demonstrated that there is no safety risk, the plugs used to connect the patient's electrical leads should be designed not to fit into other sockets in the same system that may be located in the patient's environment.
2. Line protection for medical device connectors: Wires connecting different devices in the system should be protected against mechanical damage.
Iii. Additional requirements for medical device connectors wiring:
Gb9706.1-2007 56.3c states that any connector on a wire connected to the patient shall be designed as follows: the wire on the part of the connector mentioned above at the distal end of the patient shall not be connected to the ground or touch the potentially dangerous voltage.
Any medical equipment connector (including multi-touch connector series, a number of connectors and connector) in patients with distal, namely the insertion end of the medical electrical equipment, should not be exposed metal connector plug (e.g., banana plug), which is considering if there is a metal connector plug leakage will come into contact with the ground, so the patients caused by medical equipment of high pressure may through the patients into the earth, so as to cause bodily harm to the patients.
In addition, the conductive surface of any connector should not be made too large, which also prevents the connector from possibly coming into contact with the ground.
Connectors should also be able to withstand daily wear and tear or the possibility of repeated insertion into the device socket. For this reason, the insulation of the connector should be durable and strong.