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
