Can Microsoft Embedded Standard (OS) be used for class III medical device?

Question

Or more general, can Microsoft commercial OS be used for class III medical device?

Answer 1

I forget the different classes, but if the device keeps the patient alive, then NO!

-Sean

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www.annabooks.com / www.seanliming.com / Book Author - Pro Guide to WES 7, XP Embedded Advanced, Pro Guide to POS for .NET

Answer 2

Full details are presented by the FDA:

Class I =>devices are defined as non-life sustaining. These products are the least complicated and their failure poses little risk.

Class II =>devices are more complicated and present more risk than Class I, though are also non-life sustaining. They are also subject to any specific performance standards.

Class III =>devices sustain or support life, so that their failure is life threatening.

Microsoft not suggestion using embedded OS to development for FDA class III.

Johnny

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Johnny Blog: http://johnny0627.blogspot.tw/