30
NETWORKING
certification and quality marks. When in doubt, always check
with an expert.
Scalability ensures expenditure is always perfectly
in line with current requirements. Installation can
be 60% faster than traditional network designs.
When selecting switches and other network components
to be used in a medical environment, it’s essential to check
that these not only meet required specifications but also
match the strategic vision for growth and service development
and that they comply with the relevant local legislation.
Appropriate isolation corresponding to IEC / EN 60601-1,
for example, can prevent unwanted voltage differentials
occurring between devices linked to network cabling and
provide safety protection for the entire system.
EN 60601-1-2 and ISO 14971 offer standardised
processes for guarding devices against equipment
malfunctions caused by electromagnetic interference.
Implementing these standards, as part of risk management
and installation procedures, helps to reduce the total cost of
devices throughout their lifetime, is essential to achieving
compliance with regulatory requirements and helps to
ensure the safety of all the people coming into contact with
the devices.
IEC 60601-1 classifies the network connection between a
medical device and the Ethernet network as a potential source
of danger. A leakage current can occur as a result of voltage
differences between the grounding potentials of connected
network components. Unshielded cables fail to provide
galvanic isolation for data connections in accordance with
hospital standards and poor EMC performance makes them
unsuitable for medical applications. IEC 60601-1 requires
two means of protection from electric shock to be applied
in electrical medical equipment and systems. If one means
of protection fails, the other takes effect, thereby protecting
patients as well as operators of the equipment.
When introducing communications and data systems
into a medical environment, it’s essential that all the right
precautions are taken. However, not all network components
offer overcurrent protection, double insulation, isolated
power systems and circuit breakers and so on as a standard.
Before installing any medical equipment, it’s vital to verify it
has been tested in the right way and has all the appropriate
Standards for medical electrical equipment
IEC 60601-1 defines general safety and security requirements
for medical electrical equipment and systems in the hospital
network, which the manufacturer has specified for diagnosis,
treatment or patient monitoring. Compliance with IEC60601-
1 has become a requirement for the commercialisation of
electrical medical equipment in many countries worldwide.
The EN 60601 standards family is derived from IEC 60601.
Part 1 (EN 60601-1) covers basic safety and performance
for Medical Electrical Equipment (MEC) and Part 2 covers
requirements for specific product groups. All new and existing
medical devices sold in the EU have to conform to the new
version of the standard, EN 60601-1-2, introduced on January
1, 2019. If non-medical equipment is introduced into a larger
system, suitability for use in a medical environment must be
inspected.
IEC 80001 attempts to balance patient safety,
effectiveness, data and system security and interoperability
using a risk management framework. This is a process
standard, which doesn’t detail the networking of medical
device systems.
OSHA Standard 29 CFR 1910 Subpart S – Electrical requires
that every piece of electrical equipment used in the workplace
should be factory-certified or tested and labelled by a
nationally recognised testing laboratory (NRTL).
ISO standards for medical devices are covered by ICS
11.100.20 and 11.040.01, as well as ISO 13485 and ISO
14971 for quality and risk management. ISO 13485:2003
is applicable to all providers and manufacturers of medical
devices, components, contract services and distributors of
medical devices and is widely used as the basis for regulatory
compliance.
Other standards apply to electrical and networking
equipment in the healthcare environment, as well as many
other kinds of national and supranational regulation. The EU
Medical Device Directive, for example, relates to the safety
and performance of medical devices. A manufacturer aiming
to introduce a medical device onto the European market must
meet the requirements of this directive and apply a CE mark
from a Notified Body.
A practical solution for medical networks
Fibre to the Office (FTTO) infrastructures combine copper and
fibre with intelligent conversion, offering great bandwidth
reserves, lower energy and maintenance costs, less patching
and significantly improved flexibility. A fibre network normally
needs floor distribution rooms every 90m, but FTTO does
away with this.
Scalability ensures expenditure is always perfectly in line
with current requirements. Installation can be 60% faster
than traditional network designs. No floor distributors and
cooling elements are needed, reducing energy consumption
by up to 70%. Downtime is further reduced thanks to
standard network security features.
The centralised structure means less costly and easier
servicing of the network. Regardless of size and complexity,
FTTO networks can also be easily and cost-effectively
managed from a single location. Dedicated medical FTTO
switches and other network components are available
that comply with the specialist requirements for medical
electrical equipment. n
www.networkseuropemagazine.com