CAN/CSA-ISO 11138-4:17
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)
Hardcopy , PDF
English, French
01-01-2017
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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.
| DocumentType |
Standard
|
| ISBN |
978-1-4883-1190-1
|
| Pages |
28
|
| PublisherName |
Canadian Standards Association
|
| Status |
Current
|
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.
| 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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