DIN EN ISO 15882:2008-12

Introduction
1 Scope
2 Terms and definitions
3 General considerations
4 Classes of chemical indicator
   4.1 General
   4.2 Class 1: Process indicators
   4.3 Class 2: Indicators for use in specific tests
   4.4 Class 3: Single variable indicators
   4.5 Class 4: Multi-variable indicators
   4.6 Class 5: Integrating indicators
   4.7 Class 6: Emulating indicators
5 Selection of chemical indicators
6 Use of chemical indicators
   6.1 Class 1 process indicators
   6.2 Class 2 indicators
   6.3 Class 3, 4, 5 and 6 indicators
   6.4 Indicators for use with process challenge devices
7 Interpretation of results from chemical indicators
   7.1 General
   7.2 Chemical indicator responses
   7.3 Chemical indicators showing "fail" response
8 Chemical indicators in sterility assurance procedures
   8.1 General
   8.2 Record keeping
9 Personnel training
10 Storage and handling
11 Labelling
   11.1 General
   11.2 Indicator marking
   11.3 Process marking
   11.4 Package marking
Annex A (informative) - Background on the Bowie and Dick test
Annex B (informative) - Explanation of the terms "parameter"
        and "variable"
Annex C (informative) - Rationale for the requirements for
        integrating indicators and the link to requirements
        for biological indicators (BIs) specified in the
        ISO 11138 series and microbial inactivation (derived
        from ISO 11140-1)
Annex D (informative) - Specifications for porosity
Annex E (informative) - Figure showing relationship of indicator
        components
Bibliography
National Annex NA (informative) Bibliography