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AAMI TIR14:2016 R 2024

AAMI TIR14:2016 R 2024

$80.17

AAMI TIR14:2016/(R)2024 Contract sterilization using ethylene oxide

Published By Publication Date Number of Pages
AAMI 2016 20
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This technical information report provides additional guidance to augment the ANSI/AAMI/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI/AAMI/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered. 

PDF Catalog

PDF Pages PDF Title
1 AAMI TIR14:2016/(R)2024, Contract sterilization using ethylene oxide
3 Title page
4 AAMI Technical Information Report
Copyright information
5 Contents Page
6 Glossary of equivalent standards
7 Committee representation
9 Foreword
11 1 Scope
2 Definitions
3 Selection of sterilization facility
12 4 Written agreement between product manufacturer and contract sterilizer
14 5 Validation program
5.1 General
5.2 Responsibilities
5.3 EO product families and EO processing groups
6 Handling of BIs, PCDs, and product samples
15 7 Sterilization processing documentation
7.1 Validation documentation
16 7.2 Routine processing documentation
17 8 Controls for routine processing
8.1 Product load configuration
8.2 Shipment and receipt of product for processing
8.3 Process control
8.4 Process documentation review
18 8.5 Indicators and test samples
8.6 Change controls and process deviations
8.7 Resterilization
8.8 Shipment of product following processing
19 Bibliography

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AAMI TIR14:2016 R 2024
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