Safety specifications to be met by medical device connector cables for use on medical instruments

Medical connectors and wires and cables in medical equipment to meet the general requirements of medical electrical equipment safety and medical electrical system safety requirements, and to comply with the standards and IEC standards (GB 9706.15-2008/IEC60601-1-1:2000) on the structure of components and assemblies: I. Protection against the risk of electric shock: 1. Shell: the patient's environment within the non Medical electrical equipment components that may be touched by the operator or the patient, the component's operating voltage does not exceed 25V AC, DC or peak 60V. 2. Shell leakage current and the patient leakage current: equipment that can be touched by the outer cover of the leakage current are considered to be the shell leakage current, the normal state, in the patient's environment from the system or the system components of the shell leakage current between the components should not exceed 0.1mA, CF-type Application part of the patient leakage current should not exceed 0.5mA. 3. Signal input part or signal output part of the connection: medical connectors and harness cables to do the grounding wire, if the provisions of the equipment is not connected to the system's common protective ground, you should use isolation devices. Second, the structural requirements: 1. Connection: electrical, hydraulic, pneumatic and gas connections and connectors should be designed and manufactured to prevent incorrect connection of the accessible connectors, as well as the safety hazards caused by the disassembly without tools. Unless it can be demonstrated that does not cause safety hazards, the patient circuit wires connected to the plug, should be designed to plug into the same system may be located in the patient's environment on the other sockets. 2. Medical equipment connectors connecting line protection: connecting the system of different devices in the conductor should be protected against mechanical damage. Third, the additional requirements for medical equipment connector connection line: GB9706.1-2007 in 56.3C provides in the conductive connection with the patient has any connector on the wire should be designed in the following way, that is, in the patient's remote end of the above connector part of the wire should not be grounded or exposed to possible hazardous voltages. Any medical device connector (including multi-contact connectors, several connectors, and tandem connectors) at the distal end of the patient, i.e., the plug-in end of the medical electrical device, shall not have an exposed metal plug (e.g., a banana plug) of the connector, in consideration of the fact that if the connector has an exposed metal plug it will come into contact with the ground, so that high voltages induced by the medical device at the patient may be transmitted through the patient to the earth, thus causing personal injury to the patient. This is in consideration of the fact that if the connector has an exposed metal plug, it will come into contact with the ground.

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