Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General manufacturing requirements
5 Specific manufacturing requirements
6 Determination of population and resistance
7 Culture conditions
Annex A (normative) - Determination of viable count
Annex B (normative) - Determination of growth
        inhibition by carriers and primary packaging
        materials exposed to sterilization processes
Annex C (normative) - D value determination by
        survivor curve method
Annex D (normative) - D value determination by
        fraction negative method
Annex E (normative) - Survival-kill response
        characteristics
Annex F (informative) - Relationship between
        components of biological indicators
Bibliography

Abstract

Defines general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	Canadian Standards Association
Pages
ISBN
Supersedes	CSA Z11138-1 : 2007 CSA Z11138-1 : 2007 : R2012 CSA Z11138-1 : 2007 CSA Z11138-1 : 2007 : R2012 : FR CSA Z11138-1 : 2007 : R2016