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AAMI 11138 4 2017 R2024

AAMI 11138 4 2017 R2024

$15.71

ANSI/AAMI/ISO 11138-4:2017/(R)2024 – Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat sterilization processes

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AAMI 2017
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PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 11138-4:2017/(R)2024; Sterilization of health care products—Biological indicators—Part 4: Biological indicators for dry heat 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 11138-4:2017
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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AAMI 11138 4 2017 R2024
$15.71