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: > > 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 new 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: > > > [email protected] > > >with the single line: > > > unsubscribe emc-pstc > > > > > >For help, send mail to the list administrators: > > > Ron Pickard: [email protected] > > > Dave Heald: [email protected] > > > > > >For policy questions, send mail to: > > > Richard Nute: [email protected] > > > Jim Bacher: [email protected] > > > > > >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: > [email protected] > with the single line: > unsubscribe emc-pstc > > For help, send mail to the list administrators: > Ron Pickard: [email protected] > Dave Heald: [email protected] > > For policy questions, send mail to: > Richard Nute: [email protected] > Jim Bacher: [email protected] > > 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] 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
