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
