For info, taken from the Medical Physics JISCMAIL list, (will post weblink if people are interested in joining)
MHRA is currently finalising new guidance about the permanent electrical
installation of medical devices called Medical Electrical Installation
Guidance Notes. It will be issued to compliment a new NHS Estates Document
which is also being finalised. No dates are available but it should be
this year.
The delay is due to concerns with the IEC standard and the IEE guidance
note 7.
The main delay is due the number of meetings to better clarify how the use
of Isolating Power Supplies (IPS) is determined. MHRA and NHS Estates have
agreed to not use the term IT as this is obviously confusing.
It is important to understand that IPS sockets are only to provide a
circuit that is less likely to trip than an RCD when a transient fault
occurs. IPS do not offer any protection against microshock
The whole subject is quite radical but simple but I am afraid to say that I
cannot release it because MEIGaN now needs to follow a final approval
process.
There is a chapter in MEIGaN about network isolation as connecting a
network to a medical device may affect the earth and therefore isolation of
some form must be fitted.
This is the current draft wording for the section within MEIGaN. This is
for information only. Do not use it in any form because it is not cleared
for release.
"If a Medical Device incorporates a network connection supplied by the
manufacturer, all responsibility lies with the manufacturer to ensure the
data network does not affect the safety parameters of the Medical Device.
It is the responsibility of the medical device manufacturer to ensure that
any data network connections do not affect the electrical safety features,
functions, performance of the Medical Device.
If the owner of the equipment is connecting data connection equipment to a
data port on the medical device, they must ensure that the electrical
safety of the device, is not affected (refer to IEC 60601-1-1). This
includes the earth connection. Documentation must be provided to state how
this has been achieved. The communications standard and signal strength of
the connection must also be documented (e.g. RS232 at V24).
Extra consideration must be given to Medical Devices that are used in an
interventional environment."
We may add to this and any comments on this DRAFT section are welcome.
Regards,
Ian Chell
Senior Medical Device Specialist
X-ray Imaging and Device Telecommunications
Medicines & Healthcare products Regulatory Agency
10N2 Hannibal House
London SE1 6TQ
Voice +44 (0) 20 7972 8166
Fax +44 (0) 20 7972 8113
Video +44 (0) 20 7708 5539
Cell +44 (0) 7867 537558
