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