Table of Contents

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>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;test<br>Annex B (informative) - Explanation of the terms 'parameter' <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and 'variable'<br>Annex C (informative) - Rationale for the requirements for <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;integrating indicators and the link to the requirements <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for biological indicators (BIs) specified in the ISO <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;11138 series and microbial inactivation (derived <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;from ISO 11140-1)<br>Annex D (informative) - Specifications for porosity<br>Annex E (informative) - Figure showing relationship of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;indicator components<br>Bibliography

Abstract

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.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
ProductNote	Reconfirmed EN
Pages
ISBN