{"id":430115,"date":"2024-10-20T07:21:43","date_gmt":"2024-10-20T07:21:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir52-2014-r2022\/"},"modified":"2024-10-26T14:00:35","modified_gmt":"2024-10-26T14:00:35","slug":"aami-tir52-2014-r2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir52-2014-r2022\/","title":{"rendered":"AAMI TIR52 2014 R2022"},"content":{"rendered":"

This Technical Information Report (TIR) assists in establishing an environmental monitoring program that is meaningful, manageable and defendable, and provides guidance to avoid adverse environmental conditions during the manufacture of terminally sterilized healthcare products. The objective of this TIR is to provide guidance on the routine monitoring for viable and non-viable particulates in controlled environments used to produce healthcare products that are intended to be terminally sterilized.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nBlank Page <\/td>\n<\/tr>\n
3<\/td>\nTitle page
\n <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
\n
Copyright information
\n <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
\n
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n4 General principles <\/td>\n<\/tr>\n
13<\/td>\n5 Factors to consider when establishing an EM program <\/td>\n<\/tr>\n
15<\/td>\n6 Sampling plans
7 EM methods
7.1 Airborne particulate monitoring <\/td>\n<\/tr>\n
16<\/td>\n7.2 Microbial monitoring
7.2.1 Air microbial monitoring
7.2.2 Surface microbial monitoring <\/td>\n<\/tr>\n
17<\/td>\n 7.2.3 Water microbial monitoring and compressed gasses monitoring
\n
8 Microbial characterization <\/td>\n<\/tr>\n
18<\/td>\n9 Setting alert and action levels
10 Trending results <\/td>\n<\/tr>\n
19<\/td>\n11 Investigation of EM excursions
11.1 General
11.2 Concepts of an investigation <\/td>\n<\/tr>\n
20<\/td>\n11.3 Actions taken as a result of an investigation
12 Planned and unplanned interruptions
12.1 Characterizing the impact of an interruption <\/td>\n<\/tr>\n
21<\/td>\n12.2 Activities prior to resuming manufacturing following an interruption
12.3 Documentation
13 Water monitoring <\/td>\n<\/tr>\n
22<\/td>\n14 Compressed gasses <\/td>\n<\/tr>\n
23<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR52:2014\/(R)2022: Environmental monitoring for terminally sterilized healthcare products<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n23<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":430121,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-430115","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\/430115","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\/430121"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=430115"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=430115"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=430115"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}