04/30078095 DC : DRAFT JUL 2004

Foreword
Introduction
1 Scope
  1.1 General
  1.1 Exclusions
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
  4.1 Manufacturing controls
      4.1.1 Quality systems
      4.1.2 Traceability
      4.1.3 End product requirements
      4.1.4 Personnel
  4.2 Test organism
      4.2.1 Strain
      4.2.2 Originating inoculum for suspension
      4.2.3 Test organism count
  4.3 Information supplied by manufacturer (labeling)
  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 organism
  6.4 Resistance characteristics
  6.5 Test conditions
7 Culture conditions
  7.1 Incubator
  7.2 Growth medium
  7.3 Incubation period
Annex A (normative) Determination of viable count
      A.1 General
      A.2 Minimum number of test samples
      A.3 Sample preparation
      A.4 Incubation and enumeration
Annex B (normative) Determination of growth inhibition by
                    carriers and primary packaging material
                    exposed to sterilization processes
      B.1 General
      B.2 Materials
      B.3 Methods
      B.4 Interpretation of results
      B.5 Determination of growth inhibition by packaging materials
Annex C (normative) D value determination by survivor curve method
      C.1 General
      C.2 Materials
      C.3 Procedure
Annex D (normative) D value determination by fraction negative
                    method
      D.1 General
      D.2 Materials
      D.3 Methods
          D.3.1 The Holcomb-Spearman-Karber Procedure (HSKP)
          D.3.2 The Limited Holcomb-Spearman-Karber-Procedure (LHSKP)
          D.3.3 The Stumbo-Murphy-Cochran-Procedure (SMCP)
Annex E (normative) Survival-kill response characteristic
      E.1 General
      E.2 Materials
      E.3 Method
Annex F (normative) Relationship between components of
                    biological indicators
Bibliography
Annex ZA (normative) Normative reference to international
                     publication with their relevant
                     European publications