safety, warnings, precautions, prohibitions
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© 2012 h/p/cosmos sports & medical gmbh [email protected] created 15.02.2012 printed 15.02.2012 page: 32 of 213
Class „A“ network or data network:
The general hospital network is an example for class A, such a network or data network carries general
applications including administrative or demographic patient data. The norm accepts a longer time falling out
because in hospital usually are alternatives.
For such a system the system administrator defined by the operator is responsible.
In practice such clearly defined, closed categorization / classification will not exist. The following example will
show the reason why in practice usually exists a mixture of the three classifications:
A radiology network of class B sends images and diagnostic findings from the radiology network via the general
hospital network of class A to a PACS Server (Picture and Communication System). The radiologic images are
accessible to all users can be opened in the operating room, intensive care and so on. Some manufacturers of
intensive care observation systems that, according to the norm, belong to class C offer the possibility to show x-
ray images on the bed side monitor on intensive care. In the hospitals daily routine a mixture of all three network
classes occurs. It is important that the 3
rd
edition of DIN EN 60601-1 handles the increasing networking of
medical technical devices with networks and server based databases, and shows a possible solution to cover the
complexity and potential risks of tele-medical techniques in form of the demanded system administrator or the risk
management according to DIN EN 14971.
Telemedicine is not yet described explicitly in DIN EN 60601-1 3
rd
edition, but the chapter about network and data
network includes an approach how to handle this development.
The standard requires that when using a network or data network with the aim of exchanging data between
PEMS and PEMS or other IT devices (such as servers and databases) as well the manufacturer as the operator
have the required knowledge to build such networks, to serve and control, with all related processes and
functions.
The Standard requires, for example, manufacturers or suppliers of PEMS and / or networks and data networks to
choose the configuration of their products so that they meet internationally known network standards such as
Ethernet, Fast Ethernet, GigaBitEthernet, FDDI, and others, and the available bandwidth according to the
intended use or the purpose in accordance with § 3 para 10 MPG use is appropriate and that they achieve the
optimum performance for their application.
The third Edition of DIN EN 60601-1 requires that a hospital as an operator, represented by a system integrator,
and the PEMS manufacturer discuss any major technical parameters to ensure a reliable installation of a PEMS
operating in a network or data network. This procedure is required to avoid unacceptable risks as possible.
Table H.4 of the standard gives an example of a collection of parameters that are needed to describe a network
or a data network to document and define. This list represents however only a draft, which is regarded as the
start of a comprehensive documentation.
