AAMI TIR28:2016 R 2024
$80.17
AAMI TIR28:2016/(R)2024 Product adoption and process equivalence for ethylene oxide sterilization
| Published By | Publication Date | Number of Pages |
| AAMI | 2016 | 22 |
This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI/AAMI/ISO 11135 series in the areas of product adoption and process equivalence.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | Blank Page |
| 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 Terms and definitions |
| 12 | 3 Product adoption 3.1 Establishment of an EO product family |
| 13 | 3.2 Establishment of an EO processing category 3.3 Evaluation for product adoption 3.3.1 Determination of adverse effects 3.3.2 Determination of product design effects 3.3.3 Determination of product material and characteristics effects |
| 14 | 3.3.4 Determination of sterile barrier system effects 3.3.5 Determination of load configuration effects 3.4 Conclusions of product adoption evaluation 3.4.1 Comparative resistance study |
| 15 | 3.4.2 Temperature and humidity distribution study 3.4.3 Residual study 3.5 Maintenance of EO product adoption 3.6 Documentation |
| 16 | 4 Process equivalence 4.1 General 4.2 Requirements of process equivalence 4.3 Determination of process equivalence 4.3.1 Process analysis and evaluation |
| 17 | 4.3.1.1 Evaluation of preconditioning or aeration areas 4.3.1.2 Evaluation of sterilization chamber performance |
| 18 | 4.3.2 Microbiological evaluation 4.3.3 Results evaluation 4.4 Process requalification and maintenance of equivalence 4.5 Documentation |
| 20 | Annex A Guide for evaluation of a product for adoption into an EO product family or EO processing category |
| 22 | Bibliography |
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