Do I need an isolator if I connect a medical device to a non-medical device such as a printer?

If an ME device (medical electrical device) does not have an electrical isolation device or if the Ethernet interface is only intended for combination with other ME devices and therefore does not have its own electrical isolation device, a network isolator must be used in accordance with the German MPBetreibV. Operators of medical electrical (ME) devices are responsible, among other things, for ensuring that the specifications for the intended installation, operation and use are complied with. Medical electrical equipment must be electrically safe for patients, users and operators. If a medical device is connected to a non-ME device, e.g. a printer, the created data line must be galvanically isolated in accordance with the requirements of IEC 60601-1 or EN 60601-1 and a network isolator must be used.

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