[Discuss] Open Source Sausage?

[Joel Murphy]

Great to see the subject of regulations under discussion.
I'm particularly invested in the medical/heath care area
www.pulsesensor.com
www.openbci.com

The Pulse Sensor is small and flying low, with disclaimers and 'for
entertainment purposes only' written all over it.

The OpenBCI project is smacking right up against
60601-1<http://en.wikipedia.org/wiki/IEC_60601> standards,
not to mention the FDA.
I've had to wade through a lot of misinformation to find some best practice
hard numbers to design around (how many kV isolation? creepage distance?
etc.). In the end, any electronic hardware that makes medical claims has to
pass a variety of stress tests and survive or break under acceptable
conditions. Each application is different, so attempting to provide any
advice beyond very general best practice is subject to liability.... and
some rules are not possible to follow when bits of hardware all over the
world.

The easiest thing to do is to avoid the safety issue by not getting
anywhere near to connecting to the mains...

Happy to share all I've learned on the OSHW Regulations Wiki. And help to
uncover some of the mystery.


On Mon, Oct 7, 2013 at 12:19 PM, Matt Maier <blueback09 at gmail.com> wrote:

> Under the question "*what license should I use*" the last sentence says "*Licenses
> that prevent non-commercial use are not compatible with open-source" *should
> that say "...*licenses that prevent commercial use*..." or maybe "...*licenses
> that include a non-commercial clause*...?"
>
> Some other topics the "*How does open-source hardware interact with
> hardware regulations*" answer could mention would be:
> * FCC - there are a lot of circuit boards out there that really should
> meet some kind of standard, but it's easy to fly under the radar when a
> project is small-ish and the technology moves fast.
> * Drones - at the moment there just aren't many regulations covering this
> technology, but that means the OSHW community has a chance to help
> influence regulations when they're created
> * warranties - open hardware projects tend not to prioritize safety and/or
> warranty-ability. The general assumption is that the builder takes their
> life in their own hands. But, as the FAQ section on non-commercial
> explains, it's hard to really make open hardware work without commercial
> activity, which creates a buyer-seller relationship, which brings at least
> some of the vast scope of contract law into play.
> * food - stuff that we eat is hardware, and the open source approach is
> growing in that domain. There are a lot of regulations controlling the
> creation and distribution of food.
> * children - there are a lot of regulations to protect children, which is
> important because the STEM/learning/teaching/creating nature of open
> hardware naturally leads a lot of people to want to share it with kids.
> Additionally, there are (currently) limits to the practical utility and
> or payback period of open hardware projects, which means many of them focus
> on toy or entertainment type goals.  At the end of the day kids are often
> users, or potential users, of open hardware.
> * health care - another area that the open source approach is inflitrating
> is the medical domain. Health care is pretty much synonymous with
> regulation.
> * export control - the FAQ already touches on this, but it's worth
> explaining that open source directly contradicts export control, so the
> non-discrimination requirements of open source can't be met on certain
> subjects. Granted, those subjects are kind of far out there (rockets,
> satellites, guns, etc) but it's easy to find examples of open source
> projects in those areas, and activity will only increase in the future.
>
> On Sun, Oct 6, 2013 at 12:19 PM, David A. Mellis <dam at mellis.org> wrote:
>
>> I added a simple question and answer to the end of the OSHW FAQ:
>> http://www.oshwa.org/faq/. But there's a lot more to say, I know, so
>> suggestions welcome.
>>
>>
>>
>
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>
>


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