What is the soldering standard used for medical devices?

You might find your answer in here, I did not have enough time to read the whole article.:D
www.devicelink.com/mem/archive/02/04/003.html

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.

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?

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

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.

There is one British-Adopted European Standard BS EN 61190-1-1:2002 - Attachment materials for electronic assembly. Requirements for soldering fluxes for high-quality interconnections in electronics assembly (http://www.techstreet.com/cgi-bin/detail?product_id=1117230) but not sure if it can be extended for medical devices.

Most of the medical device companies I know use IPC 610 Class III.

Most of the medical device companies I know use IPC 610 Class III.

What is the difference between IPC-A-610D and IPC 610 Class III?

What is the difference between IPC-A-610D and IPC 610 Class III?

The latter is part of the former.

My thanks for all who replied to this post. I now have an understanding of what I need. :)

IPC-A-610 is an inspection criteria. The workmanship standard for it is J-std-001. Both are available from IPC. You can use it for the EU. Life support medical devices would require class 3 others might only be class 2.

We thinking FDA and Europe. I have a copy of IPC-A-610D here, but can it be also used for CE?
While you mention about the IPC standard which is the benckmark, The soldering process needs to be validated in your application and it is here that the IPC helps.