ISO 14971 does not specify a number for an acceptable value at leaves it up to the manufacturer. Hmmm...can anyone provide some clues what whould be
an acceptable value for a physician's weighing scale?
ISO 14971 does not specify a number for an acceptable value at leaves it up to the manufacturer. Hmmm...can anyone provide some clues what whould be
an acceptable value for a physician's weighing scale?
ISO 14971 does specify a process to follow, which would yield *your own* acceptable risk level (number, if you wish). There is no golden number. The standard also suggests possible approaches. Additionally, there are heaps of guidance documents on this topic (including on determining what would be "an acceptable risk level"), available online for free. Enjoy the reading!
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