Operating a medical device on a non-medical device, such as a printer.

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

If a medical electrical device (ME) does not have galvanic isolation, or if its Ethernet interface is intended solely for use with other ME devices and therefore lacks its own galvanic isolation, a network isolator must be used in accordance with the German Medical Device Operator Ordinance (MPBetreibV). Operators of medical electrical (ME) devices are responsible, among other things, for ensuring compliance with the regulations governing proper installation, operation, and use. Medical electrical devices must be electrically safe for patients, users, and operators. If a medical device is connected to a non-ME device, such as a printer, the resulting data line must be galvanically isolated according to the requirements of IEC 60601-1 or EN 60601-1, and a network isolator must be used.