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AAMI 11138 5 2017 R2024

AAMI 11138 5 2017 R2024

$15.71

ANSI/AAMI/ISO 11138-5:2017/(R)2024 – 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
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PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 11138-5:2017/(R)2024; Sterilization of health care products—Biological indicators—Part 3: Biological indicators for moist heat
sterilization processes
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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AAMI 11138 5 2017 R2024
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