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IRNAS / pulseox-testing

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TO DO #1

Closed LukaBanovic closed 6 years ago

LukaBanovic commented 6 years ago

Find the necessary sample size, control parameters (environment, age, ....), and requirements for each step.

LukaBanovic commented 6 years ago

According to this article

SAMPLES /allowed FAILURES at 90% PCS we need 61/2 46/1 29/0

at 95% PCS we need 124/2 93/1 59/0

PCS = probability of conformance to specifications

LukaBanovic commented 6 years ago

Since Pulse-oximeters are Class II medical devices (FDA) we should have 95% PCS.

Source: https://www.qualitymag.com/articles/91991-sample-sizes-how-many-do-i-need

LukaBanovic commented 6 years ago

My suggestion of sample division:

samples

Total of 60 samples complies with 59/0 requirement. This means that our requirement is that our finger probe has to work on all tested samples.