NBN EN ISO 11138-1 : 2006

Foreword
Introduction
1 Scope
  1.1 General
  1.2 Exclusions
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
  4.1 Manufacturing controls
  4.2 Test organism
  4.3 Information supplied by manufacturer (labelling)
  4.4 Storage and transport
5 Specific manufacturing requirements
  5.1 Suspensions
  5.2 Carrier, primary and secondary packaging
  5.3 Inoculated carrier
  5.4 Biological indicators
  5.5 Self-contained biological indicators
6 Determination of resistance
  6.1 General resistance requirements
  6.2 Test organism
  6.3 Population of test organisms
  6.4 Resistance characteristics
  6.5 Test conditions
7 Culture conditions
  7.1 Incubator
  7.2 Growth medium
  7.3 Incubation
Annex A (normative) Determination of viable count
Annex B (normative) Determination of growth inhibition
        by carriers and primary packaging materials
        exposed to sterilization processes
Annex C (normative) D value determination by survivor
        curve method
Annex D (normative) D value determination by fraction
        negative method
Annex E (normative) Survival-kill response characteristics
Annex F (informative) Relationship between components
        of biological indicators
Bibliography

Offers general requirements for production, labeling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.