AAMI TIR56:2013(R2020)
Current
The latest, up-to-date edition.
GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES
Hardcopy , PDF
English
11-09-2016
Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Process descriptions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and Equipment Characterization
7 Product definition
8 Process definition
9 Validation
10 Routine Monitoring and Control
11 Product Release from Sterilization
12 Maintaining Process Effectiveness
Annexes
Annex A (informative) - Microbial Validation Using an
Augmented Overkill Approach
Annex B (informative) - Microbial Validation Using
Reduced EO Concentration
Bibliography
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