Regs for non-medical product to be used in hospitals - 61326

#1
Hi,
I have been always working in the medical device industry and now for the first time, I found myself dealing with "general products" regulations. We are trying to market a product to be used for the education of junior medical surgeons, residents, or medical school students. The device can be used anywhere including sometimes in the hospital pre-surgical labs where there may be medical electrical equipment. Our device contains an electrical component as well.
I have identified the EMC, Low Voltage, Radio Equipment and ROHS directive as those that apply to us to get the CE mark.
I wonder if there is anything else missing considering that the product may be used in the hospital environment (although it is not a medical device).

Furthermore, my big question is whether we should consider our product an electrical equipment for lab use. IEC 61326 defines lab equipment as equipment that is used for measuring, recording, controlling, monitoring, analyzing, etc., while our device is only a tool used to educate doctors and students.
Any insight on these would be highly appreciated. Thanks. - Josh
 

Ronen E

Problem Solver
Staff member
Super Moderator
#2
It's difficult to answer without knowing what the product is.
"a tool used to educate doctors and students" is a very general description and doesn't say what the device is comprised of or how it operates.
 


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