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CSA ISO 11138-2 : 2017

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CSA ISO 11138-2 : 2017

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES

Canadian Standards Association

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Table of Contents

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination of
        resistance to ethylene oxide sterilization
Annex B (informative) - Rationale for the inclusion
        of a second minimum D value specification as a
        result of changes to the test gas used to evaluate
        resistance and deletion of the requirement for a
        minimum D value at 30 degrees C
Bibliography

Abstract

Defines requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 degrees C to 65 degrees C.

General Product Information

Document Type Standard
Status Current
Publisher Canadian Standards Association