ISO 15882:2008 provides 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. ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.
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Sisällysluettelo
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 Labelling
11.1 General
11.2 Indicator marking
11.3 Process marking
11.4 Package marking
Annex A Background on the Bowie and Dick test (informative)
Annex B Explanation of the terms “parameter” and “variable” (informative)
Annex C 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) (informative)
Annex D Specifications for porosity (informative)
Annex E Figure showing relationship of indicator components (informative)
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 Background on the Bowie and Dick test (informative)
Annex B Explanation of the terms “parameter” and “variable” (informative)
Annex C 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) (informative)
Annex D Specifications for porosity (informative)
Annex E Figure showing relationship of indicator components (informative)