{"id":197958,"date":"2024-10-19T12:36:12","date_gmt":"2024-10-19T12:36:12","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11138-5-2017\/"},"modified":"2024-10-25T05:09:30","modified_gmt":"2024-10-25T05:09:30","slug":"aami-11138-5-2017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11138-5-2017\/","title":{"rendered":"AAMI 11138 5 2017"},"content":{"rendered":"
Specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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1<\/td>\n | ANSI\/AAMI\/ISO 11138-5:2017; Sterilization of health care products\u2014Biological indicators\u2014Part 3: Biological indicators for moist heat \nsterilization processes <\/td>\n<\/tr>\n | ||||||
2<\/td>\n | Objectives and uses of AAMI standards and recommended practices <\/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 Page <\/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 11138-5:2017 <\/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 1 Normative references 2 Terms and definitions 3 General requirements <\/td>\n<\/tr>\n | ||||||
14<\/td>\n | 4 Test organism 5 Suspension 6 Carrier and primary packaging 7 Inoculated carriers and biological indicators 8 Population and resistance <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | Annex A (normative) Method for determination of resistance to low-temperature steam and formaldehyde A.1 Principle A.2 Inoculated carrier exposure conditions A.3 Procedure <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | A.4 Determination of resistance <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | Annex B (informative) Rationale for the liquid-phase test method for low-temperature steam and formaldehyde biological indicators B.1 General B.2 The low-temperature steam and formaldehyde process <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 11138-5:2017 – Sterilization of health care products-Biological indicators-Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes<\/b><\/p>\n |