SN EN ISO 15882:2008

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General considerations
5 Classes of chemical indicators
   5.1 General
   5.2 Class 1: Process indicators
   5.3 Class 2: Indicators for use in specific
                tests
   5.4 Class 3: Single-parameter indicators
   5.5 Class 4: Multi-parameter indicators
   5.6 Class 5: Integrating indicators
   5.7 Class 6: Emulating indicators
6 Selection of chemical indicators
7 Use of chemical indicators
   7.1 External chemical indicators
   7.2 Internal chemical indicators
   7.3 Indicators for specific test procedures
   7.4 Indicators for use with process challenge
       devices
8 Interpretation of chemical indicators
   8.1 General
   8.2 Chemical indicator responses
   8.3 Chemical indicators showing "Fail" response
9 Chemical indicators in sterility assurance
   procedures
   9.1 General
   9.2 Record keeping
10 Labelling of chemical indicators
11 Personnel training
12 Storage and handling
Annex A (informative) Background information on the
        Bowie-Dick test
Bibliography

Defines guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation, and routine monitoring and control of sterilization processes.