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" < [email protected]> написал:
> 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! > > On Thursday, July 16, 2015 at 7:44:34 AM UTC+3, Wulf Man wrote: >> >> 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 >> On 7/15/2015 7:40 PM, Gerald Coley wrote: >> >> Robert is right. Most semiconductor companies don't like medical >> products. To much legal risk. Some parts have claimers on them. >> >> Gerald >> >> On Wed, Jul 15, 2015 at 9:30 PM, Robert Nelson <[email protected]> >> wrote: >> >>> On Wed, Jul 15, 2015 at 9:19 PM, Eliah Ninyo <[email protected]> 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/ >>> >>> -- >>> For more options, visit http://beagleboard.org/discuss >>> --- >>> You received this message because you are subscribed to the Google >>> Groups "BeagleBoard" group. >>> To unsubscribe from this group and stop receiving emails from it, send >>> an email to [email protected]. >>> For more options, visit https://groups.google.com/d/optout. >>> >> >> >> >> -- >> Gerald >> >> [email protected] >> http://beagleboard.org/ >> -- >> For more options, visit http://beagleboard.org/discuss >> --- >> You received this message because you are subscribed to the Google Groups >> "BeagleBoard" group. >> To unsubscribe from this group and stop receiving emails from it, send an >> email to [email protected]. >> For more options, visit https://groups.google.com/d/optout. >> >> >> -- > For more options, visit http://beagleboard.org/discuss > --- > You received this message because you are subscribed to the Google Groups > "BeagleBoard" group. > To unsubscribe from this group and stop receiving emails from it, send an > email to [email protected]. > For more options, visit https://groups.google.com/d/optout. > -- For more options, visit http://beagleboard.org/discuss --- You received this message because you are subscribed to the Google Groups "BeagleBoard" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. For more options, visit https://groups.google.com/d/optout.
