Hi, In response to John Allen's comment, my understanding would be that the medical electrical systems standard (60601-1-1) doesn't really help you here.
This standard covers the situation where you have a system of either interconnected electrical medical equipment or a mixed system of interconnected electrical medical equipment and other equipment (e.g. IT). The standard outlines additional measures that may be required for the system to ensure that the patient safety is not impaired by the fact that the electrical medical equipment (meeting 60601-1) is connected to non-medical equipment (meeting e.g. 60950, 61010) or by the fact that the non-medical equipment may be within the patient environment. This is separate to the issue of whether an individual item of equipment is classed as medical. The standard could be relevant though if your equipment were required to be connected to medical equipment. Hope that helps, Regards, -- Dr George Brimlow, Principal Clinical Scientist Medical Physics Dept Queen's Medical Centre Nottingham, NG7 2UH UK Tel. +44(0)115 924 9924 ext 44889 Fax +44(0)115 942 2745 [email protected] > > Hi Folks > > The basic answers to the questions of which items of "medical" equipment > are, and are not, required to be compliant to 60601 are given in EN > 60601-1-1 "Medical electrical equipment Part 1-1: General requirements for > safety. Collateral standard: Safety requirements for medical electrical > systems" > > This describes the requirements and has diagrams to illustrate the various > combinations of 60601 and non-60601 equipments. > > Regards > > John Allen > -----Original Message----- > From: Han, Delphina [mailto:[email protected]] > > 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
