Is There a Benchmark for PPM for Medical Devices?

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Statistical Steven

Statistician
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#5
We are a MD procedure pack manufacturer class 1 & IIa
There really is not benchmark or standard, but Class I devices usually are such low risk that Cpks of 1.33 - 1.5 are normal and acceptable (~100 ppm). For Class II devices, usually your strive for less than 50 ppm closer to 10 ppm. Just my own rules of thumb.

Curious what others experiences are.
 
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