AAMI 11138 2 2017
$65.83
ANSI/AAMI/ISO 11138-2:2017 – 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 |
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11138-2:2017; Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 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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