{"id":198047,"date":"2024-10-19T12:36:31","date_gmt":"2024-10-19T12:36:31","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir28-2016\/"},"modified":"2024-10-25T05:09:44","modified_gmt":"2024-10-25T05:09:44","slug":"aami-tir28-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir28-2016\/","title":{"rendered":"AAMI TIR28 2016"},"content":{"rendered":"

This technical information report provides guidance for the adoption of new or modified products into an existing validated sterilization process and for the determination of equivalence of a sterilization process as conducted with different equipment. Guidance is intended to augment the ANSI\/AAMI\/ISO 11135 series in the areas of product adoption and process equivalence.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR28:2016; Product adoption and process equivalence for ethylene oxide sterilization
\n <\/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 Page <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n3 Product adoption
3.1 Establishment of an EO product family <\/td>\n<\/tr>\n
13<\/td>\n3.2 Establishment of an EO processing category
3.3 Evaluation for product adoption
3.3.1 Determination of adverse effects
3.3.2 Determination of product design effects
3.3.3 Determination of product material and characteristics effects <\/td>\n<\/tr>\n
14<\/td>\n3.3.4 Determination of sterile barrier system effects
3.3.5 Determination of load configuration effects
3.4 Conclusions of product adoption evaluation
3.4.1 Comparative resistance study <\/td>\n<\/tr>\n
15<\/td>\n3.4.2 Temperature and humidity distribution study
3.4.3 Residual study
3.5 Maintenance of EO product adoption
3.6 Documentation <\/td>\n<\/tr>\n
16<\/td>\n4 Process equivalence
4.1 General
4.2 Requirements of process equivalence
4.3 Determination of process equivalence
4.3.1 Process analysis and evaluation <\/td>\n<\/tr>\n
17<\/td>\n4.3.1.1 Evaluation of preconditioning or aeration areas
4.3.1.2 Evaluation of sterilization chamber performance <\/td>\n<\/tr>\n
18<\/td>\n4.3.2 Microbiological evaluation
4.3.3 Results evaluation
4.4 Process requalification and maintenance of equivalence
4.5 Documentation <\/td>\n<\/tr>\n
20<\/td>\nAnnex A Guide for evaluation of a product for adoption into an EO product family or EO processing category <\/td>\n<\/tr>\n
22<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR28:2016 – Product adoption and process equivalence for ethylene oxide sterilization<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2016<\/td>\n22<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198052,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198047","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\/198047","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\/198052"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198047"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198047"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198047"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}