My opinion is that unless there are unusual circumstances, an ITE (IEC60950) certified monitor should satisfy ordinary lab needs. Any dissent?
Mike Harris/Teccom Co./Hayward CA From: "Ronald R. Wellman" <[email protected]> To: "Han, Delphina" <[email protected]>; <[email protected]> Sent: Wednesday, February 19, 2003 5:27 PM Subject: Re: IEC 61010 requirements > > Hello Delphina, > > Laboratory equipment can be considered medical devices if you advertise > them as such or claim that they can be used be physicians to form medical > opinions. However, most laboratory equipment manufacturers get around this > by claiming that their products are intended for research use only so they > don't have to make pre-market approvals to regulatory agencies. How a > hospital lab uses non-approved devices is not governed by pre-market > approval regulations because the regulations are not intended to tell > physicians how to practice medicine. > > Therefore, to answer your question concerning the use of an isolation > transformer, this will depend on whether you need to conform to the leakage > current requirements of IEC 61010-1 or 60101-1. I suggest that you purchase > copies of both standards and understand their differences. However, based > on your equipment description it appears that 61010-1 will be the safety > standard you will need to use. > > Best regards, > Ron Wellman > > 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 > 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
