AAMI TIR56:2013 R 2024
$99.13
AAMI TIR56:2013/(R)2024 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2013 | 41 |
This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR56:2013/(R)2024, Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices |
| 2 | Blank Page |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 2 Terms and definitions |
| 17 | 3 Process descriptions 3.1 Type 1 – Gas injection systems |
| 18 | 3.2 Type 2 – EO cartridge based systems utilizing permeable flexible sterilization bags |
| 19 | 3.3 Type 3 – EO cartridge based systems utilizing effectively impermeable flexible sterilization bags |
| 20 | 4 Quality management systems 5 Sterilizing agent characterization 5.1 General 5.2 Sterilizing agent 5.3 Microbicidal effectiveness 5.4 Material effects 5.5 Safety and the environment |
| 21 | 6 Process and Equipment Characterization 6.1 Process characterization |
| 22 | 6.2 Equipment characterization |
| 23 | 7 Product definition 7.1 General |
| 24 | 7.2 Demonstration of equivalence 7.3 Product safety and performance |
| 25 | 7.4 Microbiological quality 7.5 Documentation |
| 26 | 8 Process definition |
| 27 | 9 Validation 9.1 Installation qualification 9.2 Operational qualification |
| 29 | 9.3 Performance qualification 9.3.1 General 9.3.2 Performance qualification—Microbiological |
| 30 | 9.3.3 Performance qualification — Physical |
| 31 | 9.4 Varying load configurations 9.5 Review and approval of validation |
| 33 | 10 Routine Monitoring and Control |
| 34 | 11 Product Release from Sterilization 12 Maintaining Process Effectiveness 12.1 General 12.2 Calibration 12.3 Maintenance of equipment |
| 35 | 12.4 Requalification 12.5 Assessment of change |
| 36 | 12.6 Assessment of equivalence |
| 37 | Annex A: Microbial Validation Using an Augmented Overkill Approach |
| 39 | Annex B: Microbial Validation Using Reduced EO Concentration |
| 40 | Bibliography |
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