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STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
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Available format(s): Hardcopy
Language(s): German - English
Published date: 01-12-2008
Publisher: Swiss Standards
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General considerations5 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 indicators6 Selection of chemical indicators7 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 devices8 Interpretation of chemical indicators 8.1 General 8.2 Chemical indicator responses 8.3 Chemical indicators showing "Fail" response9 Chemical indicators in sterility assurance procedures 9.1 General 9.2 Record keeping10 Labelling of chemical indicators11 Personnel training12 Storage and handlingAnnex A (informative) Background information on the Bowie-Dick testBibliography
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.
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