Before Sterilization

Upper CI – St. Deviation [N] Min – Peel Test Result [N] Risk
Sealed (Refer to Table 5) Refer to Attachment #2 – Form 5 [N]
Side (A) (B) (C) = (B-A)
L N H PQ L N H PQ L
Top 1.31 1.35 2.73 2.5 5.2 5.04 6.78 6.68 3.89
Bottom 1.65 1.92 2.26 1.75 2.16 4.98 6.08 6.89 0.51
Left 2.1 3.03 4.12 5.48 8.5 4.2 5.68 11.2 6.4
Right 3.17 3.06 7.96 5.82 9.14 10.24 9.62 12.18 5.97
L = Low, N = Nominal, H = High, and PQ = Protocol Qualification

Before Sterilization
Upper CI – St. Deviation [N] Min – Peel Test Result [N] Risk
Sealed (Refer to Table 5) Refer to Attachment #2 – Form 5 [N]
Side (A) (B) (C) = (B-A)
L N H PQ L N H PQ L
Top 1.04 1.91 1.12 1.1 4.88 4 5.74 8.42 3.84
Bottom 1.62 1.17 1.67 0.97 4.98 3.22 5.06 8.1 3.36
Left 1.94 3.1 4.14 1.58 11.02 7.46 6.8 11.66 9.08
Right 2.05 2.16 8.71 1.64 11.58 10.82 9.6 11.48 9.53
L = Low, N = Nominal, H = High, and PQ = Protocol Qualification
 Risk
[N]
(C) = (B-A)
N H PQ
3.69 4.05 4.18
3.06 3.82 5.14
1.17 1.56 5.72
7.18 1.66 6.36

Risk
[N]
(C) = (B-A)
N H PQ
2.09 4.62 7.32
2.05 3.39 7.13
4.36 2.66 10.08
8.66 0.89 9.84