{"id":198410,"date":"2024-10-19T12:37:50","date_gmt":"2024-10-19T12:37:50","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir39-2009-ra-2017\/"},"modified":"2024-10-25T05:10:52","modified_gmt":"2024-10-25T05:10:52","slug":"aami-tir39-2009-ra-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir39-2009-ra-2017\/","title":{"rendered":"AAMI TIR39 2009 RA 2017"},"content":{"rendered":"
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.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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1<\/td>\n | AAMI TIR39:2009\/(R)2017; Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | AAMI Technical Information Report Copyright information <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
6<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 1 Scope 1.1 General 1.2 Exclusions 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4 Microbial challenge types and criteria for selection <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 5 Selection of product, inoculation site, and process for inoculation 5.1 Selection of product for inoculation 5.2 Selection of product inoculation site <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 7.3 Testing considerations <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" AAMI TIR39:2009\/(R)2017 – Technical Information Report Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices<\/b><\/p>\n |