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CAN/CSA-ISO 11138-2:17

Current
Current

The latest, up-to-date edition.

Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes (Adopted ISO 11138-2:2017, third edition, 2017-03)
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2017

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

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.

This is the first edition of CAN/CSA-ISO 11138-2, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-2 (third edition, 2017-03). Scope This document specifies 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 °C to 65 °C. NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for work place safety.

DocumentType
Standard
ISBN
978-1-4883-1186-4
Pages
26
PublisherName
Canadian Standards Association
Status
Current

Standards Relationship
ISO 11138-2:2017 Identical

ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 11138-1:2017 Sterilization of health care products — Biological indicators — Part 1: General requirements
ISO 14161:2009 Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results

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