The term "monitor" in the Instrumentation context does not always infers a display device. "Monitor", in this context, could refer to a data acquisition device.
I have not read anything in 601-x-x standards or the med directive, that would make me believe that the intended end-use of an instrument by a physician, in a lab enviroment only, requires compliance with 601-1. I would appreciate standard/clause reference if I have missed this.. thanx, Brian 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 ----- Original Message ----- 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? > >
