TABLE VI

HVLD Test Method Validation Results

Test methodTest unitsTotal (n)Passed (n)Failed (n)Comments
1Negative controls545212Bag 33-18 = 3.43 V (Fail)
Bag 33-22 = 3.52 V (Fail)
Positive controls, 3 μm18018
Positive controls, 5 μm18018
Positive controls, 10 μm18018
2Negative controls54540
Positive controls, 3 μm18018
Positive controls, 5 μm18117Bag 124 = 3.39 V (Pass), 5.81 μm2
Positive controls,10 μm18018
3Negative controls18180
Positive controls, 3 μm606
Positive controls, 5 μm606
Positive controls,10 μm606
4Negative controls18180
Positive controls, 3 μm615Bag 38 = 2.73 V (Pass), 3.20 μm3
Positive controls, 5 μm606
Positive controls, 10 μm606
5Negative controls18180
Positive controls, 3 μm606
Positive controls, 5 μm615Bag 114 = 2.75 V (Pass), 6.44 μm4
Positive controls, 10 μm606
6Negative controls18171Bag 33-7 = 3.31 V (Fail)
Positive controls, 3 μm606
Positive controls, 5 μm505Bag 132 data void; seal large leak
Positive controls, 10 μm606
  • 1 Bag 34-15 = 2.42 V (< Ref Min) counted as “pass.”

  • 2 Bag 124 retest = 3.49 V (Pass). Hole located in the right corner in collapsed bag cavity.

  • 3 Bag 38 right corner hole located in collapsed bag cavity.

  • 4 Bag 114 retest = 2.68 V (Pass). Hole located in the left corner of collapsed bag, about 3 mm under the metal clip.