{"id":439705,"date":"2024-10-20T08:10:40","date_gmt":"2024-10-20T08:10:40","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir21387-2023\/"},"modified":"2024-10-26T15:18:42","modified_gmt":"2024-10-26T15:18:42","slug":"aami-tir21387-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir21387-2023\/","title":{"rendered":"AAMI TIR21387 2023"},"content":{"rendered":"

Provides guidance on the requirements of ISO 11135 that apply when parametric release is used to release the product after exposure to the sterilization process. Provides a path for transition of existing cycles, as well as a path for the development and implementation of a parametric release specification for a new cycle. Highlights the importance and interrelationship of other process factors, i.e. load configuration and equipment performance, which influence reproducibility of an ethylene oxide (EO) sterilization process.<\/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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI\/ISO TIR21387:2023; Sterilization of health care products\u2014Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nCopyright information <\/td>\n<\/tr>\n
5<\/td>\nAAMI Technical Information Report <\/td>\n<\/tr>\n
6<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of AAMI adoption of ISO\/TS 21387:2020 <\/td>\n<\/tr>\n
11<\/td>\nForeword <\/td>\n<\/tr>\n
12<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 Quality management systems
5 Sterilization agent characterization
6 Process and equipment characterization
6.1 General
6.2 Process characterization
6.3 Equipment characterization <\/td>\n<\/tr>\n
16<\/td>\n7 Product definition
7.1 General
7.2 Product safety, quality and performance
7.3 Microbiological quality <\/td>\n<\/tr>\n
17<\/td>\n8 Process definition
9 Validation
9.1 General
9.2 Installation qualification
9.2.1 Equipment <\/td>\n<\/tr>\n
19<\/td>\n9.2.2 Installation qualification
9.3 Operational qualification
9.4 Performance qualification
9.4.1 General <\/td>\n<\/tr>\n
20<\/td>\n9.4.2 Performance qualification\u2014Microbiological <\/td>\n<\/tr>\n
21<\/td>\n9.4.3 Performance qualification\u2014Physical
9.5 \u200bReview and approval of validation <\/td>\n<\/tr>\n
22<\/td>\n10 Routine monitoring and control
11 Product release from sterilization <\/td>\n<\/tr>\n
23<\/td>\n12 Maintaining process effectiveness
12.1 General
12.2 Maintenance of equipment <\/td>\n<\/tr>\n
24<\/td>\n12.3 Requalification
12.4 \u200b Assessment of change
12.5 \u200b Assessment of equivalence
13 ISO 11135:2014, Annex A
14 ISO 11135:2014, Annex B <\/td>\n<\/tr>\n
26<\/td>\nAnnex A (informative) Establishing specifications for parametric release based on routine processing data
A.1 General
A.2 Procedure
A.2.1 General
A.2.2 Number of cycles to review
A.2.3 Data to be collected
A.2.3.1 Temperature
A.2.3.2 Humidity
A.2.3.3 EO concentration <\/td>\n<\/tr>\n
27<\/td>\nA.2.4 Establishing parametric release specifications
A.2.4.1 General
A.2.4.2 Analysis and specification development
A.2.4.3 Temperature
A.2.4.4 Humidity
A.2.4.5 EO concentration
A.2.5 Confirmatory MPQ cycle <\/td>\n<\/tr>\n
29<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI\/ISO TIR21387:2023 – Sterilization of health care products\u2014Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2023<\/td>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":439712,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-439705","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\/439705","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\/439712"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=439705"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=439705"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=439705"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}