George
Strictly speaking, I suppose you are correct in saying that 60601-1-1 is for
medical electrical systems, but it also gives a good insight into the
rationales behind the need to apply the medical standards, or allow use of
equipment to non-medical standards.
Therefore, if you are trying to understand where the distinction comes, then
it can assist you in making a rationale and defensible decision on the
choice of the standards to apply. As far as I can judge it was created to a
large extent because of this confusion as to where to make that distinction,
and to allow the use of "commercial" equipment in those locations where it
is obviously "safe enough".
By comparison, if you (or any one else for that matter!) can cast your mind
back some 20-25 years we were stuck (in the UK) with the infamous DHSS
"Hospital Technical Memorandum No 8" ("HTM8")which was intended to apply to
truely medical equipment but was often applied to anything in a hospital.
That was a "b*****" of a standard - very prescriptive and impossible for
much non-medical equipment to meet (e.g. EVERY exposed metal part had to be
earthed to a heavy current withstand level, regardless of whether there was
any chance of it being energised under fault conditions or not -> trying
earthing the stainless steel metal paper catcher frame for an old
line-printer to that requirement (almost impossible)!!).
Therefore with the development of IEC601 (now 60601) the reins were loosened
a bit to allow the acceptance of "commercial standards-compliant" equipment
in some areas of medical facilities - that in turn lead to confusion as to
where the decision point lies. But seeing 60601-1-1 for the first time a few
years ago, it certainly "made sense" as a very useful guidance document for
the selection of the required compliance standard - regardless of whether or
not there was/is a "medical system" involved.
EMC, on the other hand, is an entirely different issue as radiated EM
effects can spread much further than the relatively short distances
envisaged in 60601-1-1, and thus compliance with medical EMC standards may
well be a requirement to ensure non-interference with the "true" medical
equipment near to where the non-medical equipment is located. That could be
a problem - which now appears to be addressed by another thread!
(And system reliability for safety reasons is another area which I am also
not going to get into here!)
Regards
John Allen
From: George Brimlow [mailto:george.brim...@nottingham.ac.uk]
Sent: 20 February 2003 17:40
To: emc-p...@majordomo.ieee.org
Subject: Re: IEC 61010 requirements
Hi,
In response to John Allen's comment, my understanding would be that the
medical electrical systems standard (60601-1-1) doesn't really help you
here.
This standard covers the situation where you have a system of either
interconnected electrical medical equipment or a mixed system of
interconnected electrical medical equipment and other equipment (e.g. IT).
The standard outlines additional measures that may be required for the
system to ensure that the patient safety is not impaired by the fact that
the electrical medical equipment (meeting 60601-1) is connected to
non-medical equipment (meeting e.g. 60950, 61010) or by the fact that the
non-medical equipment may be within the patient environment.
This is separate to the issue of whether an individual item of equipment is
classed as medical. The standard could be relevant though if your equipment
were required to be connected to medical equipment.
Hope that helps,
Regards,
--
Dr George Brimlow,
Principal Clinical Scientist
Medical Physics Dept
Queen's Medical Centre
Nottingham, NG7 2UH
UK
Tel. +44(0)115 924 9924 ext 44889
Fax +44(0)115 942 2745
george.brim...@nottingham.ac.uk
>
> Hi Folks
>
> The basic answers to the questions of which items of "medical" equipment
> are, and are not, required to be compliant to 60601 are given in EN
> 60601-1-1 "Medical electrical equipment Part 1-1: General requirements for
> safety. Collateral standard: Safety requirements for medical electrical
> systems"
>
> This describes the requirements and has diagrams to illustrate the various
> combinations of 60601 and non-60601 equipments.
>
> Regards
>
> John Allen
> -----Original Message-----
> From: Han, Delphina [mailto:d...@strykerendo.com]
>
> Hi
>
> I am trying to find out safety requirements for devices that control and
> monitor equipment in a hospital lab (used for pathology). Does it fall
under
> the IEC 61010 standard? If so, are there any requirements for use of
> isolation transformers in that standard?
>
> Thanks in advance for your response!
>
> -Delphina
>
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