03/104519 DC : DRAFT FEB 2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
23-07-2013
23-11-2012
Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Origin of bioburden and bioburden control
4.1 Origins of bioburden
4.2 Nature of bioburden data
4.3 Monitoring of bioburden
5 Sample size
6 Sampling frequency
7 Limit setting
8 Trend analysis
9 Evaluation and corrective action
Annex A (informative) Probability of a Shewhart Control Chart for
Bioburden Data detecting a Tenfold Change in Bioburden level
with changing Sample Size and within Sample Variability
Bibliography
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