Is there a medical rating and standards for PCB components

What do you want to be certified? So, do you have a specification control drawing for each component that defines your expected performance capabilities for use by your buyer in acquiring these parts?

If there is a reason to fabricate parts to your specification, part fabricators will do that. But, �Certified For Use In Ron�s Medical Equipment�, I don�t think anyone would be crazy enough to do that. Not to say there is any thing wrong with your equipment. It�s just that without knowing the end-use application, no one is signing-up. Medical equipment covers a broad range of end-use applications.

I�m not aware of component grades, like you mention. Many parts can be purchased with tighter tolerances, but other than that, there are no �high and low grade components� like Pilsner Urquell and Mickies. There used to be �JAN� parts, but I haven�t seen reference to them in years. JAN parts were spec controlled parts. Some US government organization, like may be DESC, wrote the specification. I think all of that was bombed with the whole MIL-thing years ago.

Some service companies screen parts to your requirements. Usually this screening is value selection, but some companies burn-in components to your requirements.

Many medical equipment, aerospace, and industrial equipment companies run accelerated aging on their products prior to customer shipment. Certainly, they try to strike a balance between wringing-out infant mortality and production process defects and stripping life from their products.

Lot and serial tracing is another angle that medical equipment, aerospace, and industrial equipment companies take to provide for damage control.

Consider starting with the Federal drug Administration [FDA] Good manufacturing Practices [GMP].

reply »

Ron, have a look at http://www.fda.gov/cdrh/dsma/cgmphome.html

It would be a nightmare, if your plant is not structured to support it. It's a huge pain in the fanny even when you (alledgedly) are.

I'm not sure what you're pursuing, but if you're concerned about some sort of component certification standard for medical devices (I also know of no such standard, and I've been in that industry before), you are apparently ramping up to manufacture assemblies for med. products. If you want to call yourself a medical device manufacturer you'll need to say you are capable of QSR/GMP compliance.

For starters, think: receiving inspection testing, dimensional inspection, lot traceability, detailed procedures for all of your manual and automated processes, software validation for your automated processes, more testing, burn-in, concise maintenance plans and records, calibration of darn near everything that measures anything (we did 6" steel scales, thermocouples on reflow ovens, all soldering irons, air drivers), etc. Also a good understanding of FMEA is valuable.

Maybe you already understand this stuff, and are just looking for tools. I got the impression that you haven't yet had the pleasure of getting into the Quality Systems Regulation yet, though. Either way, I'm glad it's you and not me!

reply »