UNI EN ISO 14161 : 2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General
5 Characteristics of biological indicators
   5.1 General
   5.2 Test organism suspension for direct inoculation of
        products
   5.3 Inoculated carriers
   5.4 Self-contained biological indicators
   5.5 Other biological indicators
6 Selection of supplier
   6.1 General
   6.2 Documentation
7 Biological indicators in process development
   7.1 General
   7.2 Overkill approach
   7.3 Combined biological indicator and bioburden method
   7.4 Bioburden method
8 Biological indicators in sterilization validation
   8.1 General
   8.2 Placement and handling of biological indicators
   8.3 Sterilizer qualification
   8.4 Performance qualification
   8.5 Review and approval of validation
   8.6 Requalification
9 Biological indicators in routine monitoring
   9.1 General
   9.2 Placement and handling of biological indicators
   9.3 Process challenge device (PCD)
10 Results
   10.1 General
   10.2 Interpretation of results
11 Application of biological indicator standards
   11.1 General assessment of biological indicator
        performance by the user
   11.2 Nominal population of test organism
   11.3 Resistance determination
   11.4 z value determination
   11.5 F(T, z) equivalent sterilization value determination
   11.6 Establishing spore-log-reduction (SLR)
   11.7 Sterility assurance level (SAL) calculation
   11.8 Test equipment
12 Culture conditions
   12.1 General
   12.2 Incubation temperature
   12.3 Incubation period
   12.4 Choice of growth medium
13 Third-party requirements
   13.1 General
   13.2 Minimum requirements for replicates and total number
        of biological indicators
   13.3 Test equipment
14 Personnel training
15 Storage and handling
16 Disposal of biological indicators
Annex A (informative) - Microbiological inactivation kinetics
        and enumeration techniques
Annex B (informative) - Process challenge devices
Annex C (informative) - Formulae for fraction negative
        methods for D value calculations
Annex D (informative) - Examples of documentation for
        biological indicators prepared by the user
Annex E (informative) - Calculation of z value
Annex F (informative) - D value determination by survivor
        curve method
Annex G (informative) - Survival-kill response characteristics
Bibliography

Supplies guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes. Also relates to biological indicators for which International Standards exist.