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

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