TABLE IV

HLVD Test Results for Pooled Negative Control Populations, at Lower and Upper Sensitivity Set Points

HVLD Test Method123456
High voltage set point (kV)12.512.512.512.512.512.5
Sensitivity limit range275–285255–265250–260240–250255–265240–250
Mean (V)2.952.962.762.842.822.85
Standard deviation (V)0.160.180.140.140.170.15
Coefficient of variation0.050.060.050.050.060.05
Count180300168168168196
Mean ± 3 standard deviations (V)2.47–3.432.42–3.502.34–3.182.42–3.262.31–3.332.40–3.30