AAMI TIR39 2009 RA 2017
$75.64
AAMI TIR39:2009/(R)2017 – Technical Information Report Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 21 |
This technical information report provides guidance on selecting the appropriate form of microbial challenge to use in a validation process and the appropriate inoculation sites for that microbial challenge.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR39:2009/(R)2017; Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 1.1 General 1.2 Exclusions 2 Normative references 3 Terms and definitions |
| 15 | 4 Microbial challenge types and criteria for selection |
| 16 | 5 Selection of product, inoculation site, and process for inoculation 5.1 Selection of product for inoculation 5.2 Selection of product inoculation site |
| 17 | 5.3 Process for inoculation 5.3.1 General 5.3.2 Considerations for use of inoculated carriers 6 Testing and assessment of inoculated product 6.1 Testing of inoculated product |
| 18 | 6.2 Assessment of inoculated product test results 7 Considerations for the use of liquid inoculum 7.1 Use of liquid inoculum 7.2 Testing of inoculated product |
| 19 | 7.3 Testing considerations |
| 20 | Bibliography |
