Comment Bioburden Determination of Verification dose Verification dose

ISO 11137 Method 1 Most popular 10 devices from 3 different lots Batch average if > 2 x overall avg Otherwise overall avg, use Table B 100 units, 2 + ok

ISO 11137 Method 2 No prelim. Bioburden needed 9 minimum incremental dose levels, 20 devices/level, up to 840 devices

ISO 13409 Steady small lot production 10 devices, 1 lot Average must be less than 1000 cfu Irradiate 10-90 samples at 10-2 dose from I and S values, Table 2, Less than 1+ 10-20 samples, less than 2+ , 30-90

AAMI VDmax Same as method 1 except 25kGy substantion 10 devices from 3 different lots Batch average if > 2 x overall avg Otherwise overall avg, use Table B 10 units at verification dose (101), if 1+, 25 kGy substantiated, if 2+, take 10 more devices, repeat verification dose, if 0+ 25 kGy substantiated, if 1+, 25kGy not acceptable if 3+ 25 kGy not acceptable 25 kGy Quarterly

AAMI TIR 15843 Allows dose audit reductions after 1 year Bioburden based on master product with highest in typical load No verification dose

Sterilisation dose Dose audit

10-6 Table B1 Quarterly

25kGy for 3 lots, then dosimetric release Quarterly

Alternate Plan I 52 devices, 0+ ok, 1-2+ : 52 more devices, 2+ ok Alternate Plan II 70 devices, 1+ ok, 2-3+: 130 more devices,2+ ok Alternate Plan III 140 devices, 1-4+ ok, unacc if 5+. 25 kGy Quarterly for 1 year, if: stable bioburden, dose, positives, then semi annual for 2 years, then annual if dose augmentation or failure, back to quarterly 50 devices, 0+ ok 1-3+, 100 more devices, 4+ ok otherwise, unacc.

Dose audit devices Augment dose

10 bioburden conf. 100 verification dose, 2 + ok, on 3+, augment If 3,4+ or 5,6 + w/bioburden increase, augment dose by greater of Table B1 based on bioburden or multiply orig. bioburden x 10 and used table B1. if 5,6 + w/o bioburden increase, go to step 1 if 7 +, go to step 1