Need information for designing medical product

[ericmar]

Dear all,

I need some information such as the requirements for designing an isolation circuit to meet the standard for medical device so tat the device can be considered Safe and would be recognised by FDA. For example, the gap between 2 isolated circuit on the PCB, the minimum voltage the device need to withstand when surge occurs without hurting the end users.

Thank,
Eric Mar

 

[IanP]

The most important principle of the IEC 60601-series is to ensure safety for
patients, users and others in normal use and normal condition as well as in a single fault condition. This is specifically important for life supporting and life-sustaining equipment where an interruption could cause a hazard for the patient.
Safety of the equipment should be considered part of the overall safety situation, comprised also of the safety of the equipment installation, equipment maintenance and the safety of equipment application.

Quoted from:
http://www.conformity.com/0308european.pdf
What you need to get is the IEC60601, which is the basic safety standard for electrical medical equipment ..
It is available on the Internet, but it is not free ..
Of course these standards are only guidelines and will not provide you with direct hints on details, but if you would like to design/manufacture/supply medical equipment you HAVE to comply with them ..
Regards,
IanP

 

[leomecma]

It is a difficult topic, because even manufactures like National don't sell components for medical equipament without authorization of company president ... this show how difficult is this topic ....

leomecma