M00012887
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STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - GUIDANCE FOR SELECTION, USE AND INTERPRETATION OF RESULTS
Canadian Standards Association
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Availability date: 10/28/2021
Foreword<br>Introduction<br>1 Scope<br>2 Terms and definitions<br>3 General considerations<br>4 Classes of chemical indicator<br>5 Selection of chemical indicators<br>6 Use of chemical indicators<br>7 Interpretation of results from chemical indicators<br>8 Chemical indicators in sterility assurance procedures<br>9 Personnel training<br>10 Storage and handling<br>11 Labelling<br>Annex A (informative) - Background on the Bowie and Dick <br> test<br>Annex B (informative) - Explanation of the terms 'parameter' <br> and 'variable'<br>Annex C (informative) - Rationale for the requirements for <br> integrating indicators and the link to the requirements <br> for biological indicators (BIs) specified in the ISO <br> 11138 series and microbial inactivation (derived <br> from ISO 11140-1)<br>Annex D (informative) - Specifications for porosity<br>Annex E (informative) - Figure showing relationship of <br> indicator components<br>Bibliography
Specifies 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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | Canadian Standards Association |
ProductNote | Reconfirmed F |
Pages | |
ISBN |