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ISO 11138-5 : 2017

M00024623

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ISO 11138-5 : 2017

STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 5: BIOLOGICAL INDICATORS FOR LOW-TEMPERATURE STEAM AND FORMALDEHYDE STERILIZATION PROCESSES

International Organization for Standardization

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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

This document specifies 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 International Organization for Standardization
Committee TC 198
Supersedes
  • ISO/DIS 11138-5 : 60.00 (2016)