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CAN/CSA-ISO 11138-4:17

Current
Current

The latest, up-to-date edition.

Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization (Adopted ISO 11138-4:2017, second edition, 2017-03)
Available format(s)

Hardcopy , PDF

Language(s)

English, French

Published date

01-01-2017

Publisher

Canadian Standards Association

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

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.

This is the first edition of CAN/CSA-ISO 11138-4, Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11138-4 (second 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 sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C. NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857. NOTE 2 Requirements for work place safety can be provided by national or regional regulations.

DocumentType
Standard
ISBN
978-1-4883-1190-1
Pages
28
PublisherName
Canadian Standards Association
Status
Current

Standards Relationship
ISO 11138-4:2017 Identical

ISO 18472:2006 Sterilization of health care products Biological and chemical indicators Test equipment
ISO 20857:2010 Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices
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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Hardcopy - English
PDF - English
Hardcopy - French
PDF - French
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