NS EN ISO 15882 : 2ED 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. Applies to chemical indicators for which International Standards exist (see ISO 11140 series).