Page 198 - Assurance of Sterility for Sensitive Combination Products and Materials

178 Assurance of sterility for sensitive combination products and materials

1.E−06 99.9999% 4,605,168 2995,731 2302,584

1.E−05 99.999% 460,515 299,572 230,258

1.E−04 99.99% 46,050 29,956 23,025

The sample sizes associated with reliability claims assuming no failures are observed.
1.E−03 99.9% 4603 2995 2302

1.E−02 99% 459 299 230

5.E−02 95% 90 59 45

1.E−01 90% 44 29 22

99% 95% 90%

Table 7.3 PNSU* Reliability Confidence