Peter, Please let me have the name of the surgeon with the cellphone, so I'll be careful to avoid him!!
Best Wishes, Jon On 21 Feb 2003 at 15:17, peter merguerian wrote: > > Jon, > I must say that I somewhat disagree with you. A medical equipment as defined in IEC60601-1 is one > that is for "professional use. The surgeon's e-mails PC can also be used by his son and I do not > consider it "professional" in the sense of the standard. > Let's not exagerate here! A person with too many medical devices should stay in bed. > The other day, I called a surgeon and he happened to be in the operating room with his cellphone > performing an operation. Does that make his cellular comply with IEC 601-1? > Peter > > Jon Griver <jgri...@601help.com> wrote: > > Delphina, > > It's not only an issue of intended use, but also a question of location. With regard to the example > you give, if a PC for the surgeon's urgent emails is located within the 'patient vicinity', as > defined in IEC 60601-1-1 (within about 6 feet of the patient's bed), then I believe that it should > comply with IEC 60601-1, even though it's not a medical device. > > The reasoning behind this is that the patient could possibly touch the PC (that's the logic behind > the 'patient vicinity' concept), and close a leakage current loop, together with other medical > instruments with which he is in contact. This could be particularly nasty if there is a fault in > the PC's earth wire. > > Regards, > > Jon Griver > http://www.601help.com > The Medical Device Developers Guide to IEC 60601-1 > > > On 20 Feb 2003 at 12:38, Han, Delphina wrote: > > &! gt; > > Hi all, > > > > Thanks for your responses. When I originally asked the question, I was sure > > that the particular equipment I was asking about does not fall under the > > scope IEC60601, but I wanted to confirm if IEC61010 is the relevant > > standard. As you may notice, I have a copy of the IEC60601 standard but not > > IEC61010! I also needed to find out if there were special requirements for > > isolation transformers in IEC61010. > > > > >From the discussion, it seems that which standard to comply with is > > dependent on the intended use, and not where the equipment is placed. So, if > > we put a PC in the hospital operating room, but it is just for the surgeon > > to let's say, check email (not practical...but this is just an example), > > would 60950 be the relevant standard? I doubt it'd have to meet 60601 > > requirements. > > > > How about EMC standards? (maybe I should start a ne! w thread...). Will this > > PC have to meet IEC 60601-1-2! for medical? Or EN 55022 for ITE? Bear in mind > > this is in the hospital operating room. I am familiar with medical equipment > > requirements but not so much with ITE, so forgive me if I'm making mistakes > > here. > > > > My thoughts are all from the regulatory point of view. Of course if the > > customer wants compliance with a more stringent requirement, that is what he > > gets... > > > > I appreciate all your thoughts/comments! > > > > -Delphina > > > > > > > > > > > > > > At 09:10 AM 2/19/2003 -0800, Han, Delphina wrote: > > > > > > >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.or! g > > > > > > > >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 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 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 > > > Do you Yahoo!? > Yahoo! Tax Center - forms, calculators, tips, and more 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
