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CSA ISO 11138-5 : 2017

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CSA ISO 11138-5 : 2017

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE 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 low-temperature steam and formaldehyde
Annex B (informative) - Rationale for the liquid-phase test
        method for low-temperature steam and formaldehyde
        biological indicators
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 low-temperature steam and formaldehyde as the sterilizing agent.

General Product Information

Document Type Standard
Status Current
Publisher Canadian Standards Association