{"id":198104,"date":"2024-10-19T12:36:43","date_gmt":"2024-10-19T12:36:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11737-2-2019\/"},"modified":"2024-10-25T05:09:55","modified_gmt":"2024-10-25T05:09:55","slug":"aami-11737-2-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11737-2-2019\/","title":{"rendered":"AAMI 11737 2 2019"},"content":{"rendered":"

Specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent that is a fraction of the specified sterilization process. These tests are intended to be performed when defining, validating or maintaining a 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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 11737-2:2019; Sterilization of medical devices\u2014Microbiological methods\u2014Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of ISO 11737-2:2019 <\/td>\n<\/tr>\n
10<\/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
16<\/td>\n4 General
5 Selection of product
5.1 General <\/td>\n<\/tr>\n
17<\/td>\n5.2 Sample item portion (SIP)
5.3 Packaging of product and sample item portions <\/td>\n<\/tr>\n
18<\/td>\n6 Methods for performing tests of sterility <\/td>\n<\/tr>\n
19<\/td>\n7 Assessment of the method for performing tests of sterility
8 Maintenance of the method for performing tests of sterility <\/td>\n<\/tr>\n
20<\/td>\nAnnex A (informative) Guidance on tests of sterility performed in validation and maintenance of a sterilization process
A.1 Scope
A.2 Guidance on normative references
A.3 Guidance on terms and definitions
A.4 General
A.5 Selection of product
A.5.1 General <\/td>\n<\/tr>\n
21<\/td>\nA.5.2 Guidance on sample item portion (SIP)
Table A.1 \u2014 Examples for selection of SIP <\/td>\n<\/tr>\n
22<\/td>\nA.5.3 Packaging of product and sample item portions
A.6 Methods for performing tests of sterility <\/td>\n<\/tr>\n
25<\/td>\nA.7 Assessment of method for performing tests of sterility <\/td>\n<\/tr>\n
26<\/td>\nA.8 Maintenance of the method for performing tests of sterility <\/td>\n<\/tr>\n
27<\/td>\nAnnex B (informative) Typical assignment of responsibilities
Table B.1 \u2014 Typical assignment of responsibilities <\/td>\n<\/tr>\n
28<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11737-2:2019 – Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n29<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198107,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198104","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\/198104","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\/198107"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198104"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198104"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198104"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}