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CSA ISO 11138-4 : 2017

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CSA ISO 11138-4 : 2017

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 4: BIOLOGICAL INDICATORS FOR DRY HEAT 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 dry heat sterilization
Annex B (normative) - Calculation of z value
Bibliography

Abstract

Defines requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 degrees C to 180 degrees C.

General Product Information

Document Type Standard
Status Current
Publisher Canadian Standards Association