Xray Safe, is it?

[Eliah Ninyo]

hello,

we think about using BeagleBone card for Xray medical device.

does anyone have any information about it? is beaglebone board is Xray safe?

thanks in advance,

[Gerald Coley]

I have to admit. I have never taken an Xray of a BBB. It should not be an issue. However, to be sure, I suggest you take the BOM and contact each manufacturer to be sure.

Gerald

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Gerald

 

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[William Pretty Security]

I think what he means Gerald, is the BBB approved for “medical applications” the way some power supplies and other equipment is.

[Gerald Coley]

TI devices are not approved for use in medical devices. There are XRAY machines that are used to XRAY PCBs. I doubt those qualify as medical devices..

Gerald

[Eliah Ninyo]

Thanks for the answers!

What do you mean by "TI devices are not approved for use in medical devices"?
I'm not talking about PCB X-ray, I'm talking about X-ray for medical purposes (CT scanner).

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[Robert Nelson]

On Wed, Jul 15, 2015 at 9:19 PM, Eliah Ninyo <eni...@gmail.com> wrote:
> Thanks for the answers!
>
> What do you mean by "TI devices are not approved for use in medical
> devices"?

It means exactly what it says.. Medical devices have to follow
rules/regulations in the us and it big $'s money...

Regards,

--
Robert Nelson
https://rcn-ee.com/

[Gerald Coley]

Robert is right.  Most semiconductor companies don't like medical products. To much legal risk. Some parts have claimers on them.

Gerald

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[evilwulfie]

last page of the  tech ref manual

No TI components are authorized for use in FDA Class III (or similar life-critical medical equipment)
unless authorized officers of the parties have executed a special agreement specifically governing such use

CT scanners are a class II device so it seems you are in the clear.
http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm203018.htm
BUT run it by a lawyer for your protection

N

[Eliah Ninyo]

thanks for the answers

i guess no manifacture admit he can work in medical device, this is why we do a verification and validation to every product specificly

thanks!

[Maxim Podbereznyy]

TI should not qualify own products for medical applications, an end-user should. For example TI makes chips for ECG, but it does not mean that you build your own ECG machine and it should be automatically approved by any medical organization. A manufacturer of this product should pass all tests and certifications. It cost a lot of $ and takes time

16 Июл 2015 г. 10:16 пользователь "'Eliah Ninyo' via BeagleBoard" <beagl...@googlegroups.com> написал:

[William Hermans]

TI should not qualify own products for medical applications, an end-user should. For example TI makes chips for ECG, but it does not mean that you build your own ECG machine and it should be automatically approved by any medical organization. A manufacturer of this product should pass all tests and certifications. It cost a lot of $ and takes time

+1