The right declaration for network insulators in the medical field
Devices for galvanic isolation of Ethernet data signals, so-called network isolators, are used as part of a medical electrical system consisting of active medical products (e.g. ultrasound or endoscope) and not medical products (e.g. computers, switches).
The Medical Devices Act defines medical devices as products that
(a) the detection, prevention, monitoring, treatment or alleviation of disease,
(b) the detection, monitoring, treatment, alleviation or compensation of injuries or disabilities,
(c) the examination, replacement or modification of the anatomical structure or physiological process; or
(d) the rules on conception
None of these criteria are fulfilled by network insulators, therefore a network insulator by definition cannot be a medical device in the sense of the MPG. Accordingly, the conformity of a network insulator is not to be declared by the manufacturer according to the Medical Device Directive 93/42 EEC, but according to the Low Voltage Directive 2006/95 EC and the EMC Directive 2004/108 EC. Since network insulators are intended for use in medicine, the manufacturer should continue to present a standard certificate in accordance with DIN EN 60601-1 and DIN EN 60601-1-2 (EMC standard) as well as the test reports of the test laboratory as proof that it has performed the corresponding tests in accordance with the standards mentioned.
A safety check (STK) of these devices must therefore not be carried out according to MPBetreibV (Medizinprodukte Betreiberverordnung) but according to BGV A3 at the intervals specified by the manufacturer in the accompanying documents. Only when the MI 1005 is used as part of a medical electrical system can it be inspected in the course of the STK of the overall system according to the manufacturer's specifications.
Baaske Medical GmbH Co. KG offers the MI 1005 Medical Isolator for safe galvanic isolation of medical electrical systems. The MI 1005 Medical Isolator is recommended for use in the immediate vicinity of the device to be isolated, as this is the only way to ensure that no external potential is unintentionally introduced on the signal path.