AAMI 11138 4 2017
$65.83
ANSI/AAMI/ISO 11138-4:2017 – Sterilization of health care products-Biological indicators-Part 4: Biological indicators for dry heat sterilization processes
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 21 |
Provides specific 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..
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11138-4:2017; Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat 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 11138-4:2017 |
| 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 dry heat sterilization A.1 Principle A.2 Procedure A.3 Determination of resistance |
| 17 | Annex B (normative) Calculation of z value |
| 18 | Table B.1—Examples of data collected for regression analysis Table B.2—Examples of calculations for slope |
| 21 | Bibliography |
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