I saw this pre-print on BioRxiv:
Open Design 3D-Printable Adjustable Micropipette that meets ISO Standard for Accuracy
Does anyone else have experience with trying to get their hardware to conform to ISO standards that they’d like to share? Or opinions on if/when it is worth the effort.
Some preliminary digging into centifuge safety standards with @Tobey revealed that they exist e.g. ISO 6178:1983 Centrifuges – Construction and safety rules – Method for the calculation of the tangential stress in the shell of a cylindrical centrifuge rotor. They’re not free (38 USD in that case) but for safety critical features there would appear to be a stronger argument for at least being aware of the standard even if it isn’t possible to conform due to design or resource constraints.
I don’t know much about ISO standards, but I have been familiarizing myself with EMC standards recently (e.g., electromagnetic emissions and immunity). These standards apply broadly to anything containing electronics and are designed to ensure that your hardware is not going to cause interference with any other electrical equipment (emissions standards) or be affected by RF noise, electrostatic discharges, etc. (immunity standards).
If you’re just posting designs online for people to build themselves, you probably don’t need to worry about such things; but if you ever want to sell a product, adhering to at least the emissions standards is mandatory in most jurisdictions (e.g., FCC in the US, Industry Canada, Europe requires compliance with both emission and immunity standards to attach a CE mark to any product, etc.).
Even in the simplest cases, emission testing can cost several thousand dollars (sometimes over ten thousand dollars for immunity testing). Selling non-compliant electronic widgets could subject you to significant fines and it may be difficult to ship things across borders without documentation of compliance. This creates a significant barrier to small-scale production of hardware, especially when you consider that any non-trivial change/revision you make to your product can require a retest.
There’s also the issue of safety standards (e.g., UL, CSA, TUV, etc.). From my understanding, these are not strictly required to legally sell a product, but they may be required by some customers (e.g., US government labs). Conformance with these standards requires some hefty fees and on-going testing (factory inspections, etc.).
I don’t claim to be an expert on these issues, but I am gaining a practical education while trying to commercialize DropBot, our wetlab microfluidics robot. I’m happy to share my experience going through the process if anyone is interested. Even if you don’t plan to “sell” a product, I would argue that it’s not a bad idea to at least know the basics and to try and design with them in mind.
Thanks for the detailed reply Ryan, I found this really useful reading. I hadn’t even considered emissions testing!
Have you found any good resources to help people through this? Seems like lots of people have to tread the same ground and I wonder if something to work on at GOSH would be a quick and necessarily incomplete guide?
Lots will be application specific of course, but from an analagous position of having set up an organisation recently and learnt a lot that I thought would just be easy to find out and wasn’t, it could be worth having on a wishlist of useful things for the GOSH community, if not proposing an unconference session.
I think walking through standards and requirements for making and shipping hardware internationally would be super useful. I know a little, but could learn a lot! We should consider this as unconference session
Yes, I have a couple of good technical resources. This website http://www.emcfastpass.com/ offers a free EMC design book (note that you need to register your email to download it) and has a number of interesting articles/blog posts on the subject.