Medical devices regulation regarding types of flux

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IanTrout

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Hi all,

I have a small regulation question regarding production of medical devices:
Is there a definition somewhere of what types of flux can and cannot be used in medical devices?

I know that the solder wire should always be RoHS, but this is a more general regulation and not medical devices specific,
but is there something in the books about flux?


Thanks in advance,
Trout
 

I know that the solder wire should always be RoHS, but this is a more general regulation and not medical devices specific,
but is there something in the books about flux?
Medical devices should not be RoHS compliant, as well as the motion controllers and automotive/avionic electronics.

As for flux, that is something that is inside of the device, can not be ingested and does hot come in contact with skin. :smile:
 

Thanks, this helps a lot!

One question though - what do you mean that medical devices don't need RoHS?
The EU requires every electronic device to be RoHS compliant, and the US has started this in all states beginning from 2014 (if i'm not mistaken)...



Thanks,
Trout
 
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There are some extempts from RoHS.

Restriction Exemptions


Quote is from: https://en.wikipedia.org/wiki/Restriction_of_Hazardous_Substances_Directive
 

It is not so much the flux that you need to worry about it is having the assemblies done to IPC class 3 standard, same with the PCB.
here is a quick link;

**broken link removed**
 

Thanks for the link @marce!
But I don't think this really applies for us, its only for R&D use...


Thanks for all the help,
Trout
 

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