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CE marking of network isolators

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. Network_isolator_MED_MI_1005
Built in Medical Isolator MI 1005 E
Built in Medical Isolator MI 1005 E TÜV certified isolator for galvanic network isolation of medical electrical devices Safety: IEC 60601-1:2005/AMD1:2012/AMD2:2020 (Edition 3.2) EMV: EN 60601-1-2:2015 (IEC 60601-1-2:2014) (Medical electrical equipment) In addition to network isolators with fixed cables, the medical isolator MI 1005 E offers a simple and cost-effective way to isolate medical devices, starting at the wall of the housing. This makes the insulator particularly well-suited for medical device makers. Using standard Harting PushPull technology, the MI 1005 E Medical Built In insulator can be installed quickly and easily into existing devices. Long-term availability also offers planning certainty necessary for new product development. Under stress conditions the MI 1005 isolator was tested up to a isolation stength of 10 kV DC (10 Sec.) and 5 kV AC (60 Sec.). Furthermore, 8 kV contact discharge and 16 kV air discharge are easily fulfiled. Benefits: Ideal for medical device manufacturers Insulation from the device housing wall Easy installation thanks to Harting PushPull technology Offers planning security – long-term availability Passive component – without additional power supply
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Network Isolator MI 1005 MB
Network Isolator MI 1005 MB Wall-mounted medical network isolator with Harting PushPull technology Safety: IEC 60601-1:2005/AMD1:2012/AMD2:2020 (Edition3.2) EMV: EN 60601-1-2:2015 (IEC 60601-1-2:2014) (Medical electrical equipment) The MI 1005 MB passive network isolator is specifically designed for wall mounting in medical environments. It provides galvanic network isolation for electronic medical devices and systems starting directly at the wall outlet. Once it is mounted to the wall, the isolator is well-protected by the housing. Accidental impacts can be absorbed, protecting the isolator and network cable connector from damage. The MI 1005 MB network isolator delivers dielectric strength up to 5 kV, up to 10 kV DC for 10 seconds under high-stress conditions. Coupled with Harting PushPull technology, an absolutely stable connection. No installation of drivers or additional software necessary because the MED MI 1005 MB network isolator behaves fully transparently on the data network. Benefits: Fixed installation – flush-mounted fitting Protects medical devices and patients against excessively high leakage currents in the data network Durable housing – absorbs minor impacts to protect the isolator and network connection cable No installation of drivers or additional software required Inexpensive and efficient operation. No dedicated power supply required Completely secure connection when coupled with Harting PushPull technology
Network Isolator MI 1005
Netzwerkisolator MI 1005 TÜV-certified network isolator for galvanic isolation Safety: IEC 60601-1:2005/AMD1:2012/AMD2:2020 (edition 3.2) EMV: EN 60601-1-2:2015 (IEC 60601-1-2:2014) (medical electric devices) The MI 1005 5 kV RJ-45 network isolator is used for the galvanic isolation of an Ethernet data line. It offers outstanding performance with only 1 dB attenuation and operates with virtually no loss in the data network over a distance of 100 m. Connected devices are reliably protected against external and internal overvoltages that can occur due to installation errors or environmental influences such as lightning strikes. The MI 1005 network isolator provides a flexible and simple way to immediately isolate medical devices. Users and inventory are protected in less than 5 seconds from dangerous leakage currents that can flow through the data network. Areas of application The MI 1005 network isolator reliably protects patients, medical devices, and users from excessive leakage currents flowing through the data network, which can occur unpredictably at any time. Measuring & monitoring devices Sensitive measuring and monitoring devices in electrical test fields that are connected to a control center via Ethernet interfaces are protected against interference voltages and potential differences. Server systems To prevent failures or equipotential bonding currents, network isolators protect server systems that are connected over long distances using copper cabling. Audio applications The MI 1005 provides reliable protection against power surges and low-frequency AC voltage (mains hum) and prevents noise interference in the sound. Network isolators in medical technology In the medical field, the MI 1005 network isolator serves to protect patients from leakage currents. The network connection between an active medical device and an Ethernet network or a non-medical device, such as an office PC, printer, or laptop, is safely galvanically isolated in accordance with the IEC 60601-1 standard for medical electrical equipment and systems. In accordance with the requirements of IEC 60601-1 (Edition 3.2), the MI 1005 network isolator has two independent protective measures (2 MOPP) for patients and is therefore ideal for the standard-compliant galvanic isolation of Ethernet-based signal interfaces within the patient environment. Under stress conditions, the MI 1005 network isolator guarantees up to 10 kV DC (10 sec.) insulation resistance and 5 kV AC (60 sec.), and also easily meets 8 kV contact discharge and 16 kV air discharge requirements. Example in a patient environment The use of the MI 1005 ensures electrical safety in the patient environment in accordance with applicable standards—a simple, effective, and standards-compliant solution. Commissioning The MI 2005 network isolator can be put into operation by simply inserting it into existing network cabling. The passive electronic components do not require their own power supply and behave completely transparently in the data network. No drivers or additional software need to be installed. Benefits: Easy to use – no software installation required Compact and universally applicable In less than 5 seconds, the patient, user, and equipment are protected from dangerous leakage currents Lightweight and durable housing – can be connected to any system with a network connection Inexpensive to purchase and efficient to operate – does not require its own power supply Tested in accordance with IEC 60601-1:2005/AMD1:2012/AMD2:2020 (Ausgabe 3.2)