NS 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 Biological indicators
 6 Selection of supplier
  6.1 General
  6.2 Documentation
 7 Biological indicators in process
         development
  7.1 General
  7.2 Reference microorganism method
  7.3 Combined biological indicator and
         bioburden method
  7.4 Bioburden method
 8 Biological indicators in sterlization
         validation
  8.1 General
  8.2 Placement and handling of biological
         indicators
  8.3 Sterlizer qualification
  8.4 Performance qualification
  8.5 Review and approval of validation
  8.6 Requalifications
 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 D-value determination
  11.4 Testing equipment
 12 Culture conditions
  12.1 General
  12.2 Incubation temprature
  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 of biological indicators
         collected by the user
         Bibliography

Provides 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.