Question for the people who are/were/are thinking about selling Open source scientific hardware:
What is your take on certifications? I’m thinking about CE marks adn FCC… The reason I ask is that we are trying to develop the FlyPi further and get it ready to be a kit.
Advice from university was to get it certified to avoid liability and problems down the road.
Problem is that these certifications cost time and money (estimatives are around 10 to 20k Euros), which would them implicate in the final price and accessibility of our device.
When looking at other companies selling OScH, I noticed that most of them do not have these types of certifications (some of them even responded my inquires with: uh, we just ignored it.)
So to narrow down my question (even if these are more questions ):
Is this something you considered? if so, why did you for having or not having it certified?
Is getting something certified a plus when concerning credibility/quality of your design?
If you decided for not certifiying your device, is this something you explicitly mention to users/customers so that they are aware?
Hi @amchagas
As long as you use certified modules, you don’t need to get certified by yourself.
For example, this WiFi and BLE module is certified for FCC, CE ( RED ), IC, TELEC, SRRC & KCC. http://espressif.com/en/products/hardware/esp-wroom-32/overview
So I always choose such modules for products, even though most of them are just breakouts of core chips.
thanks for the info. Was it never the case for you that you needed to create a PCB for instance, to glue all the modules together? And if so, wouldn’t one need to certify the PCB itself?
On the non-electronic side of the device, don’t you need to certify the mechanical parts? (at least for CE there is a general safety certification that would fit here, I think)
We’ve been thinking about using breakouts for our system so that we can at least take this “out of the way” but it seems it would increase our prices too…
Regarding what @shingohisakawa said above, using certified radio modules can reduce the burden of testing (you can test as an unintentional radiator instead of an intentional radiator), but it doesn’t solve the problem completely based on my understanding. I would recommend checking out summaries by sparkfun and hackaday and I also wrote a blog post with some good references.
Basically it depends on the jurisdictions you plan to sell to and what type of product you are making. There are also differences between what are called intentional and unintentional radiators. Intentional radiators (e.g., gadgets with a bluetooth or wifi radio) are more complicated (i.e., expensive), so using pre-certified radio modules can definitely make your life easier, but you still need to confirm that the rest of your product (e.g., microcontroller clock, power supply, etc.) are not unintentionally radiating emissions beyond the limits.
For unintentional radiators, you generally don’t need “certification”, but you are ultimately responsible for “compliance” with the regulations. You aren’t required to hire a test facility (i.e., you can self-test if you know what you are doing), but if your product produces emissions in excess of the regulated levels, you could be forced to pay hefty fees and/or recall your product. To sell to Europe, there are additional considerations to declaring that your product is in compliance with CE regulations (it may be turned back at the border without a CE mark). These include things like lead free status and immunity (making sure that your product can operate in the presence of electrical noise, power surges, etc.).
In reality, if you are only selling a small volume to people you know and it is unlikely that anyone will file a complaint, you could probably slip under the radar and many people do. Testing is certainly a huge barrier to market for small companies and OSH (e.g., we spent >$10k and over 8 months to bring DropBot into compliance, so I can certainly sympathize with your position). It’s even worse in my opinion that you need to retest if you make any changes to your product…
The current regulatory framework is prohibitively expensive for small companies and/or niche markets. I did a lot of reading to try and figure out a way to avoid this testing (there are a few exceptions, but they are pretty limited). I think that if you want to do things by the book, testing is a necessary evil.
Hey, for selling OpenFlexure microscope kits through WaterScope, we don’t include any custom PCBs so have sidestepped that issue. The only electronics involved that we produce ourselves is an LED + resistor, so we’ve not worried overly much. We’ve also concentrated on selling kits, so I don’t think that is any of the product categories that requires a CE mark. I do make sure that I used lead free solder when I solder the LED and resistor though
Hey André!
We had the same problem for some “products” we wanted to sell. At least CE only applies for things you want to sell on the open market. Since you mainly want to sell to universities and research facilities there is most likely a loophole. Talk to the startup/innovation division of your university. They usually know a lot about intellectual property and getting a scientific prototype to market. They will know if there is a way, like a contract for the buyer "We understand by buying that this device … ". These people work free of charge and at least in the few encounters I had, they were very happy that some one visited them.
Hi Ben!
Yeah, we tried contacting them, but the advice wasn’t that helpful… (side note, the person who spoke to us was using IE as their “go to” tool for internet browsing. At the Technology transfer office. I Mean… come on!)
I can try to go there again, since I have a better idea after all the comments and can make a more educated question…
It is important that you remember you should test as much as you think is adequate as it’s impossible to test to all the worlds individual country standards. The major ones are self-ceritifications (FCC & CE) so you state that your product complies and you should have some documentation showing you went to reasonable effort to be sure of that.
EMC test prices can quckly get out of hand. For a recent product we went with the EMC Test Club and got very reasonable rates.
I have made BLE radio device from scratch (CSR1010 BLE chip) and company obtained FCC and CE/ROHS with my help on the cheap using FCC certified lab in China! If you know what where it is not that hard (i pretested system with SDR radio on my own to avoid fail/retesting cost)… These certificates does clear only institutional liability, but personal one due to x you can only imagine, no type of certification will help you there, pretty much Ryanfobel’s story is spot on, customs, import/sale documents, compatibility, conformity and similar low level legal crap…
@amchagas I follow the same rules. Our 3D printers use electronics parts that already have CE mark. My company focuses on the local market, users/customers can ask us about our products directly. They are aware which kind of product are buying.
Some great info here guys - thanks! I’m also coming across this certification step (CE, FCC) for what we’re building too -will keep you guys updated with any best practices/shortcuts I come across
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