AAMI 11138 5 2017
$65.83
ANSI/AAMI/ISO 11138-5:2017 – Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
| Published By | Publication Date | Number of Pages |
| AAMI | 2017 | 19 |
Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 11138-5:2017; Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat sterilization processes |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents Page |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 9 | Background of AAMI adoption of ISO 11138-5:2017 |
| 10 | Foreword |
| 11 | Introduction |
| 13 | 1 Scope 1 Normative references 2 Terms and definitions 3 General requirements |
| 14 | 4 Test organism 5 Suspension 6 Carrier and primary packaging 7 Inoculated carriers and biological indicators 8 Population and resistance |
| 16 | Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde A.1 Principle A.2 Inoculated carrier exposure conditions A.3 Procedure |
| 17 | A.4 Determination of resistance |
| 18 | Annex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators B.1 General B.2 The low-temperature steam and formaldehyde process |
| 19 | Bibliography |
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