Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Quality management system elements<br>5 Sterilizing agent characterization<br>6 Process and equipment characterization<br>7 Product definition<br>8 Process definition<br>9 Validation<br>10 Routine monitoring and control<br>11 Product release from sterilization<br>12 Maintaining process effectiveness<br>Annex A (informative) - Guidance<br>Annex B (informative) - Process definition based on <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;inactivation of the microbial population in its <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;natural state (bioburden-based method)<br>Annex C (informative) - Process definition based on the <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;inactivation of a reference microorganism and a <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;knowledge of bioburden on product items to be <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;sterilized (combined bioburden/biological <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;indicator based method)<br>Annex D (informative) - Conservative process definition <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;based on inactivation of reference microorganisms <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(overkill method)<br>Annex E (informative) - Operating cycles<br>Bibliography

Abstract

Describes requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.

General Product Information

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