iec 60601 isolation requirement
Dear all,
I just want to know if I design an isolation circuit for a medical device, must I use the components such as Digital Isolator & isolated DC/DC converter IC that comply to the IEC60601-1? If the Safety and regulatory approvals is not stated in the datasheet of these components, then wat can I do to find out whether or not it complies the standard? Wats the minimum isolation voltage for IEC60601-1?
I am still new in design circuit for medical grade products so not too sure about wat n how to follow in order to fulfill the standard. I did read through the IEC document but it does not really specify in detail as in the minimum isolation voltage.
Thanks a lot!
Regards,
Eric Mar