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AAMI 11138 2 2017 R2024

AAMI 11138 2 2017 R2024

$15.71

ANSI/AAMI/ISO 11138-2:2017/(R)2024 – Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes

Published By Publication Date Number of Pages
AAMI 2017 18
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PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 11138-2:2017/(R)2024; Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes
3 Title page
4 AAMI Standard
Copyright information
5 Contents
6 Glossary of equivalent standards
7 Committee representation
9 Background of AAMI adoption of ISO 11138-2:2017
10 Foreword
11 Introduction
13 1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
14 6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
16 Annex A (normative) Method for determination of resistance to ethylene oxide sterilization
A.1 Principle
A.2 Procedure
A.3 Determination of resistance
17 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 C
B.1 Inclusion of a second minimum D value
B.2 Deletion of the requirement for a D value at 30 C
18 Bibliography

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AAMI 11138 2 2017 R2024
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