AAMI TIR56 : 2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
13-01-2020
English
01-01-2016
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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