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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES
Canadian Standards Association
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Availability date: 10/28/2021
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.
Published | |
Document Type | Standard |
Status | Current |
Publisher | Canadian Standards Association |
Pages | |
ISBN |