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 > This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: davehe...@attbi.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc _____________________________________________________________________ This e-mail has been scanned for viruses by the WorldCom Internet Managed Scanning Service - powered by MessageLabs. 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