Is USB-IF standard compliant with ISO13485?

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yodon

Staff member
Super Moderator
#2
There's nothing in 13485 (directly) that would indicate that or any standard is compliant (or not). The key is what the regulatory requirements are for particular countries in which you want to distribute. There are certainly medical devices that incorporate USB in their product design.

Maybe I'm not understanding the question?

Oh, and you posted this in the FDA regulations but the title mentions 13485. FDA doesn't recognize 13485. FDA has its own Quality System Regulations.
 
#3
Thanks for your reply first of all.

My question is:
we are design a portable biomedical device. We need to provide also a charging cable with ubs type c to type A. The first requirements is that the cable is compliant with USB-IF standard. This last is compliant with ISO60601 and EIA-364.

Is this standard enough for medical device? Or we should look for a different cable?
Is the USB-IF standard compliant also with ISO13485?

Thanks a lot!!
 

yodon

Staff member
Super Moderator
#4
IEC 60601-1 is a recognized / harmonized standard in the medical device world so your device will, I presume, undergo testing to demonstrate compliance to that standard. If parts are already certified compliant then that aspect usually doesn't have to undergo any additional testing.

You should be good!
 
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