{"id":465638,"date":"2024-10-20T10:41:40","date_gmt":"2024-10-20T10:41:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir562013-r-2024\/"},"modified":"2024-10-26T19:42:58","modified_gmt":"2024-10-26T19:42:58","slug":"aami-tir562013-r-2024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir562013-r-2024\/","title":{"rendered":"AAMI TIR56:2013 R 2024"},"content":{"rendered":"

This AAMI Technical Information Report (TIR) provides information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.  <\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR56:2013\/(R)2024, Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices <\/td>\n<\/tr>\n
2<\/td>\nBlank Page <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
12<\/td>\nForeword <\/td>\n<\/tr>\n
13<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n3 Process descriptions
3.1 Type 1 – Gas injection systems <\/td>\n<\/tr>\n
18<\/td>\n3.2 Type 2 \u2013 EO cartridge based systems utilizing permeable flexible sterilization bags <\/td>\n<\/tr>\n
19<\/td>\n3.3 Type 3 – EO cartridge based systems utilizing effectively impermeable flexible sterilization bags <\/td>\n<\/tr>\n
20<\/td>\n4 Quality management systems
5 Sterilizing agent characterization
5.1 General
5.2 Sterilizing agent
5.3 Microbicidal effectiveness
5.4 Material effects
5.5 Safety and the environment <\/td>\n<\/tr>\n
21<\/td>\n6 Process and Equipment Characterization
6.1 Process characterization <\/td>\n<\/tr>\n
22<\/td>\n6.2 Equipment characterization <\/td>\n<\/tr>\n
23<\/td>\n7 Product definition
7.1 General <\/td>\n<\/tr>\n
24<\/td>\n7.2 Demonstration of equivalence
7.3 Product safety and performance <\/td>\n<\/tr>\n
25<\/td>\n7.4 Microbiological quality
7.5 Documentation <\/td>\n<\/tr>\n
26<\/td>\n8 Process definition <\/td>\n<\/tr>\n
27<\/td>\n9 Validation
9.1 Installation qualification
9.2 Operational qualification <\/td>\n<\/tr>\n
29<\/td>\n9.3 Performance qualification
9.3.1 General
9.3.2 Performance qualification\u2014Microbiological <\/td>\n<\/tr>\n
30<\/td>\n9.3.3 Performance qualification \u2014 Physical <\/td>\n<\/tr>\n
31<\/td>\n9.4 Varying load configurations
9.5 Review and approval of validation <\/td>\n<\/tr>\n
33<\/td>\n10 Routine Monitoring and Control <\/td>\n<\/tr>\n
34<\/td>\n11 Product Release from Sterilization
12 Maintaining Process Effectiveness
12.1 General
12.2 Calibration
12.3 Maintenance of equipment <\/td>\n<\/tr>\n
35<\/td>\n12.4 Requalification
12.5 Assessment of change <\/td>\n<\/tr>\n
36<\/td>\n12.6 Assessment of equivalence <\/td>\n<\/tr>\n
37<\/td>\nAnnex A: Microbial Validation Using an Augmented Overkill Approach <\/td>\n<\/tr>\n
39<\/td>\nAnnex B: Microbial Validation Using Reduced EO Concentration <\/td>\n<\/tr>\n
40<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR56:2013\/(R)2024 Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2013<\/td>\n41<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":465645,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-465638","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/465638","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/465645"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=465638"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=465638"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=465638"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}