{"id":395478,"date":"2024-10-20T04:20:00","date_gmt":"2024-10-20T04:20:00","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir100-2021\/"},"modified":"2024-10-26T08:05:53","modified_gmt":"2024-10-26T08:05:53","slug":"aami-tir100-2021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir100-2021\/","title":{"rendered":"AAMI TIR100 2021"},"content":{"rendered":"

This technical information report (TIR) provides guidance for a comprehensive framework that integrates and connects Microbiological Quality & Sterility Assurance (MQ&SA) into an organization\u2019s end-to-end process for the development, validation, and routine control of sterile health care products.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR100:2021; End-to-end microbiological quality and sterility assurance <\/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
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 General <\/td>\n<\/tr>\n
15<\/td>\n5 Research and Development (R&D)
5.1 Design inputs <\/td>\n<\/tr>\n
16<\/td>\n5.2 Design process <\/td>\n<\/tr>\n
17<\/td>\n5.3 Design outputs
5.4 Design verification <\/td>\n<\/tr>\n
18<\/td>\n5.5 Design validation
5.6 Design transfer
6 Plan
6.1 Infrastructure <\/td>\n<\/tr>\n
19<\/td>\n6.2 Work environment and microbiological control
6.3 Sourcing (purchasing) <\/td>\n<\/tr>\n
20<\/td>\n6.4 Control of production
7 Source <\/td>\n<\/tr>\n
21<\/td>\n7.1 Identification and selection of supplier for goods and services
7.2 Verification (i.e., inspection) of the goods and services
7.3 Monitoring and re-evaluation of the goods and services <\/td>\n<\/tr>\n
22<\/td>\n8 Make
8.1 Infrastructure
8.2 Work environment and microbiological control
8.3 Sourcing (purchasing) <\/td>\n<\/tr>\n
23<\/td>\n8.4 Control of production
9 Deliver <\/td>\n<\/tr>\n
24<\/td>\n9.1 Maintenance of product conditions
9.2 Maintenance of the sterile barrier
10 Customer <\/td>\n<\/tr>\n
25<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR100:2021, End-to-end microbiological quality and sterility assurance<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2021<\/td>\n27<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":395487,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-395478","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\/395478","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\/395487"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=395478"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=395478"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=395478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}