3D Printer Regulatory Compliance

Hello all,
I have been involved in product development for many years and, as of late, been working on a 3d printer design (like everyone and their brother, lol). Many industries have regulatory and compliance bodies which new products are submitted to for approval prior to retail sale. Is there any such body for manufacturers of 3d printers? I assume one would need submission to FCC in the states and possibly UL, and I think CE approval is required for most devices for import into the EU. So, do the 3d printer companies all get these approvals or is it the wild west out there?

Thanks,
Jim

When the Nanny State and the Risk Averse collide, printed guns bad...real guns ok!
I'm sure they are trying to get in on the action, under the guise of protecting us.
I wonder if the individual components are safe & authorized does the assembly need to be?

I am not sure, but I bet you could ask Lulzbot. They sell worldwide (as far as I know) and they are very open-source friendly.

For Europe you will need CE. If you import to the EU without CE you may not get the printers over the border. But only if they check it. So you might get lucky.

If you sell in the EU without CE then that might work. Most people don't know or don't care. So it is not impossible to do it.

The question is what happens if someone burns down his house because your printer over heated. In that case the authorities check and you might get into big trouble if you have no CE or did not do it right. (I don't want to recommend to just put CE on a printer to avoid problems when selling. But the CE concept is in a way that that would be enough until the first house burns,..)

This applies for printers. It is not clear if it also applies for Kits. It might though.

But say some idiot(and by idiot i mean unlucky & forgetful ) buys a CE approved iron, and forgets to turn it off before going to work, returns to find home reduced to ashes, who's fault is it.
or the hotend cartridge starts a fire, how do they prove it was the original that came with printer?
I have no idea how long cartridges typically last, but so far so good, I doubt I will try to sue when it fails.

"Nothing is foolproof to a sufficiently talented fool"
"If you make something idiot proof, someone will just make a better idiot."
“You can't make anything idiot proof because idiots are so ingenious.”

I know i shouldnt take a nap while printing but sometimes i just have to, foolish i know.
....and thats what u get for fallin asleep...filament snag, grrr

Edited 6 time(s). Last edit at 08/12/2016 10:02AM by MechaBits.

@MechaBits IANAL but I think you are over generalizing.

If you burn down your house the Fire Department will search for the reason. The police and your insurance will be interested in the cause.

If someone else started a fire in your house that is a job for the police.

If you just fell asleep in the wrong moment. Or something else happened that you did not cause directly. Your insurance should pay for the rebuild of your house.

If they find that you bought something that does not have the safety certification that it legality bindingly needs. Then the insurance may say that they don't pay. They will argue that the product was dangerous (it obviously was as it burned down your house) and they will either make the person that sold it to you or yourself responsible for the damage.

There are laws that make it illegal to sell stuff that was not tested to be secure. And the reason for these laws are the availability of so many fools.You may like this or not. But in practice this works relatively well with the fools available.

And "safety certified" does not mean idiot proof. If you did not apply all the safety measures stated in the manual, and if the product was safety certified then it will be your fault that the house burned down.

The tricky part is a printer that has no safety testing and a user that might or might not be an idiot. Here the seller of the printer might get into trouble but again IANAL!

what Insurance?
dont get me started on that racket!
If they find that you bought something that does not have the safety certification that it legality bindingly needs....
Does this mean I can then sue customs & excise for negligence letting said dodgy part it into the country?
If its a kit then only individual parts could be tested, the first whiff of magic smoke i've had was my own stupid fault.
luckily todays sleep only resulted in clogged nozzle.

but as you say the law is the law and if, perhaps dc42 or someone else can give us an idea of what things cost to get the correct certifications?

I do safety critical software to pay the bills. 3d printing is just my hobby.

If you want to know the cost then you have to differ between hardware and software:

On the hardware side (I'm a software developer, so this might be inaccurate) you need to know the safety specification and have to build in stuff to avoid all the dangers. On the mechanical side look at the Ultimaker+ vs the Ultimaker Original. The Metal shield around the nozzle is one of the additional hardware features put in to get certifications (avoiding that the user touches a hot surface).

For electronics you need to at least do an EMI test. That will cost in the range of a few thousand (€ or $) for each test. So if you fail the test you have to pay this again after you changed your PCB.

The plus side is that this is then valid until the next hardware change.

On the software side it is even worse. The problem is the authorities acknowledge that it is not possible to proof that a software has no errors. The result is that they force you to use a long list of methods so that we can all hope that the resulting software will have less than a certain amount of software errors with the potential to kill people. Therefore the software for the accelerator in your car is something totally different to the software in you GPS or the radio. The amount of effort needed to create "safety critical" software therefore directly relates to the amount of damage your software can cause. That's why software for planes is much harder to write than software for cars. A critical error would simply kill more people. (Why do I now think about "Fight Club" ...)

If you decide to do all the required things to get your certification. You will now need much more people to implement the same amount of code. Think 5 times as much or 10 times as much. This rule that only 10% of the work is actually coding, and the rest should be design and testing,.. becomes a reality. And all those cool new features are not allowed any more. You need to use very limited compilers and and very restricted frameworks if you can use them at all, because everything else is unsafe. By they way they force you to do Waterfall and create hundreds of documents. A safety assessor will tell you that he believes that you tested it and that it will work, but unless he sees the test specification and the test report he must assume that the test never happened. And then again with the first change of the code (even if it is only a comment) your certificate becomes invalid, as you now have a new and different software.

The logical thing to do in such a situation would be to move all the potentially critical stuff into hardware, right? But guess what the metal shield that doesn’t let you touch the hot nozzle costs a few cent in every machine sold. The additional safety check in the firmware that makes the code ugly only costs once. And as everybody nowadays sells millions of products more and more safety stuff moves into software,..

So for open hardware / open software with daily changes by many people in the community getting a safety certificate is impossible. The only thing we can do is listen to those companies that sell printers and try to make their life easier. And respect them if they choose to not use the latest and greatest change of the day in their products right away.


PS: You will not be able to sue customs, as you have been the one buying the stuff abroad. If you buy it in your country then you can sue whoever sold it to you, maybe. Again IANAL.

interesting read, not really thought about safety in coding, my old mate designed computer games(psygnosis) it never came into any discussions,
obviously code for self driving cars & other things that could be dangerous has to have checks in place, but as you said there is always revisions, updates, in the meantime some people may still get hurt even with the checks and certs.
but I was talking about buying parts on ebay, from abroad, if customs let them in and they havent passed regulations,
its all very well these customs & trading standards going after hoverboards & ecig's after they discover they are fakes or dangerous,
perhaps if they had better controls at the borders they wouldnt let items through without verifying they have the required certificates.
but I understand that might be a little more work for them that they cant b r s ed.

Edited 1 time(s). Last edit at 08/13/2016 06:49PM by MechaBits.