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) - Evaluation of a sterilization <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;process primarily based on the measurement<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of physical parameters<br>Annex B (informative) - Evaluation of a sterilization <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;process primarily based on biological inactivation <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and an accompanying mechanical air removal procedure<br>Annex C (informative) - Temperature and pressure of <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;saturated steam for use in moist heat sterilization<br>Annex D (informative) - Special considerations for health <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;care settings<br>Annex E (informative) - Index of normative clauses/subclauses <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;of ISO 17665-1 and cited references or related <br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;guidance given in ISO 17665-1 and ISO/TS 17665-2<br>Bibliography

Abstract

Specifies general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1.

General Product Information

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