Page 197 - Assurance of Sterility for Sensitive Combination Products and Materials

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Assurance of sterility for sensitive combination products and materials
The sample sizes associated with reliability claims assuming no failures are observed.
5.E−02 1.E−06 1.E−05 1.E−04 1.E−03 1.E−02 99.9999% 99.999% 99.99% 99.9% 99% 95% 4,605,168 460,515 46,050 4603 459 90 2995,731 299,572 29,956 2995 299 59 2302,584 230,258 23,025 2302 230 45

1.E−01 90% 44 29 22

99% 95% 90%

Table 7.3 PNSU* Reliability Confidence