Glossary of equivalent standards
Committee representation
Background of AAMI adoption of ISO 15882:2008
Foreword
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 Labeling
   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 the 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