{"id":198046,"date":"2024-10-19T12:36:31","date_gmt":"2024-10-19T12:36:31","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir14-2016\/"},"modified":"2024-10-25T05:09:44","modified_gmt":"2024-10-25T05:09:44","slug":"aami-tir14-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir14-2016\/","title":{"rendered":"AAMI TIR14 2016"},"content":{"rendered":"

This technical information report provides additional guidance to augment the ANSI\/AAMI\/IS0 11135 series both for medical manufacturers that use contract sterilization facilities and for contract sterilization operations. It addresses how ANSI\/AAMI\/ISO 11135:2014 applies to ethylene oxide sterilization operations for devices marketed in the United States. Ethylene oxide sterilization guidance for health care facilities is not specifically covered.<\/p>\n

PDF Catalog<\/h4>\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 TIR14:2016, Contract sterilization using ethylene oxide <\/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 Definitions
3 Selection of sterilization facility <\/td>\n<\/tr>\n
12<\/td>\n4 Written agreement between product manufacturer and contract sterilizer <\/td>\n<\/tr>\n
14<\/td>\n5 Validation program
5.1 General
5.2 Responsibilities
5.3 EO product families and EO processing groups
6 Handling of BIs, PCDs, and product samples <\/td>\n<\/tr>\n
15<\/td>\n7 Sterilization processing documentation
7.1 Validation documentation <\/td>\n<\/tr>\n
16<\/td>\n7.2 Routine processing documentation <\/td>\n<\/tr>\n
17<\/td>\n8 Controls for routine processing
8.1 Product load configuration
8.2 Shipment and receipt of product for processing
8.3 Process control
8.4 Process documentation review <\/td>\n<\/tr>\n
18<\/td>\n8.5 Indicators and test samples
8.6 Change controls and process deviations
8.7 Resterilization
8.8 Shipment of product following processing <\/td>\n<\/tr>\n
19<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR14:2016 – Contract sterilization using ethylene oxide<\/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>\n20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198050,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198046","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\/198046","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\/198050"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198046"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198046"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198046"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}