cont'd

The greatest number of days of incubation required to obtain more than 97% positive BIs (based on the 7 day incubation time) in any one of the partial cycles is the minimum incubation time that will be allowed. Averaging the three (or more) partial cycle incubation times is not allowable (see example in Appendix).

If the biological indicator user has not or cannot validate the biological indicator incubation period using the described methodology, then the user should remain with at least a seven day incubation period.

Number Positive Biological Indicators Required to Achieve 97% Growth

Numerator Data¹	30	31	32	33	33	34	35	36	37	38
Denominator Data²	30	31	32	33	34	35	36	37	38	39
Numerator Data	39	40	41	42	43	44	45	46	47	48
Denominator Data	40	41	42	43	44	45	46	47	48	49
Numerator Data	49	50	51	52	53	54	55	56	57	58
Denominator Data	50	51	52	53	54	55	56	57	58	59
Numerator Data	59	60	61	62	63	64	65	65	66	67
Denominator Data	60	61	62	63	64	65	66	67	68	69
Numerator Data	68	69	70	71	72	73	74	75	76	77	78
Denominator Data	70	71	72	73	74	75	76	77	78	79	80

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