{"id":457351,"date":"2024-10-20T09:50:43","date_gmt":"2024-10-20T09:50:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11138-2-2017-r2024\/"},"modified":"2024-10-26T18:17:45","modified_gmt":"2024-10-26T18:17:45","slug":"aami-11138-2-2017-r2024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11138-2-2017-r2024\/","title":{"rendered":"AAMI 11138 2 2017 R2024"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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1<\/td>\n | ANSI\/AAMI\/ISO 11138-2:2017\/(R)2024; Sterilization of health care products\u2014Biological indicators\u2014Part 2: Biological indicators for ethylene oxide sterilization processes \n <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | AAMI Standard 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 | ||||||
7<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Background of AAMI adoption of ISO 11138-2:2017 <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 5 Test organism <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 6 Suspension 7 Carrier and primary packaging 8 Inoculated carriers and biological indicators 9 Population and resistance <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | Annex A (normative) Method for determination of resistance to ethylene oxide sterilization A.1 Principle A.2 Procedure A.3 Determination of resistance <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | Annex B (informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 30 C B.1 Inclusion of a second minimum D value B.2 Deletion of the requirement for a D value at 30 C <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 11138-2:2017\/(R)2024 – Sterilization of health care products\u2014Biological indicators\u2014Part 2: Biological indicators for ethylene oxide sterilization processes<\/b><\/p>\n |