Soldering Standard - What is the soldering standard used for medical devices?

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W

WBubel - 2010

#3
Re: Soldering Standard

Sorry, perhaps I was not clear on my question. I am looking for a standard (ISO, ANSI, AAMI etc) which the medical industry must comply to.
 

Le Chiffre

Quite Involved in Discussions
#4
Re: Soldering Standard

I'd hazard a guess that it's IPC-A-610 class III, but are you sure it's mandatory? I assume you're thinking of the FDA or has this requirement come from somewhere else?
 
W

WBubel - 2010

#5
Re: Soldering Standard

We thinking FDA and Europe. I have a copy of IPC-A-610D here, but can it be also used for CE?
 

yodon

Staff member
Super Moderator
#6
Re: Soldering Standard

This is a bit out of my zone, but I'm not aware of any prescribed standards for soldering. I *do know* that the FDA expects you to validate your soldering process. That's one of those low hanging fruits that auditors check first.
 
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