{"id":198164,"date":"2024-10-19T12:36:54","date_gmt":"2024-10-19T12:36:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-15882-2008-ra-2013\/"},"modified":"2024-10-25T05:10:06","modified_gmt":"2024-10-25T05:10:06","slug":"aami-15882-2008-ra-2013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-15882-2008-ra-2013\/","title":{"rendered":"AAMI 15882 2008 RA 2013"},"content":{"rendered":"

This document provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. AAMI\/ISO 15882:2008 applies to indicators that show exposure to sterilization processes by means of physical and\/or chemical change of substances, and which are used to monitor one or more of the variables required for a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism.<\/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\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 15882:2008\/(R)2013, Sterilization of health care products \u2014 Chemical indicators\u2014 Guidance for selection, use and interpretation of results <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page
\n <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
7<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
9<\/td>\nCommittee representation <\/td>\n<\/tr>\n
12<\/td>\nBackground of AAMI adoption of ISO 15882:2008 <\/td>\n<\/tr>\n
13<\/td>\nForeword <\/td>\n<\/tr>\n
14<\/td>\nIntroduction <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Terms and definitions <\/td>\n<\/tr>\n
17<\/td>\n3 General considerations <\/td>\n<\/tr>\n
20<\/td>\n4 Classes of chemical indicator
4.1 General
4.2 Class\u00a01: Process indicators <\/td>\n<\/tr>\n
21<\/td>\n4.3 Class\u00a02: Indicators for use in specific tests
4.4 Class 3: Single variable indicators <\/td>\n<\/tr>\n
23<\/td>\n4.5 Class\u00a04: Multi-variable indicators
4.6 Class\u00a05: Integrating indicators <\/td>\n<\/tr>\n
24<\/td>\n4.7 Class\u00a06: Emulating indicators <\/td>\n<\/tr>\n
25<\/td>\n5 Selection of chemical indicators <\/td>\n<\/tr>\n
26<\/td>\n6 Use of chemical indicators
6.1 Class\u00a01 process indicators
6.2 Class\u00a02 indicators
6.3 Class\u00a03, 4, 5 and 6 indicators
6.4 Indicators for use with process challenge devices <\/td>\n<\/tr>\n
27<\/td>\n7 Interpretation of results from chemical indicators
7.1 General <\/td>\n<\/tr>\n
28<\/td>\n7.2 Chemical indicator responses
7.3 Chemical indicators showing \u201cfail\u201d response
8 Chemical indicators in sterility assurance procedures
8.1 General <\/td>\n<\/tr>\n
29<\/td>\n8.2 Record keeping
9 Personnel training
10 Storage and handling <\/td>\n<\/tr>\n
30<\/td>\n11 Labeling
11.1 General
11.2 Indicator marking
11.3 Process marking
11.4 Package marking <\/td>\n<\/tr>\n
32<\/td>\nAnnex A Background on the Bowie and Dick test <\/td>\n<\/tr>\n
35<\/td>\nAnnex B Explanation of the terms \u201cparameter\u201d and \u201cvariable\u201d <\/td>\n<\/tr>\n
36<\/td>\nAnnex C Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators (BIs) specified in the ISO 11138 series and microbial inactivation (derived from ISO 11140-1)
C.1 Steam
C.1.1 Introduction
C.1.2 Background information
C.2 The link between the integrator stated value (SV) and biological indicator (BI) inactivation <\/td>\n<\/tr>\n
39<\/td>\nC.3 Comparison with the requirements for integrating indicators in ISO 11140-1 <\/td>\n<\/tr>\n
42<\/td>\nC.4 Ethylene oxide <\/td>\n<\/tr>\n
44<\/td>\nAnnex D Specifications for porosity
D.1 General
D.2 Comparison of five paper samples
D.2.1 Test materials
D.2.2 Conditions
D.2.3 Test methods
D.2.3.1 Air permeance in accordance with ISO 5636-3
D.2.3.2 Air permeance in accordance with ISO 5636-5[2] <\/td>\n<\/tr>\n
45<\/td>\nD.2.4 Test results <\/td>\n<\/tr>\n
46<\/td>\nAnnex E Figure showing relationship of indicator components <\/td>\n<\/tr>\n
47<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 15882:2008\/(R)2013 – Sterilization of health care products – Chemical indicators-Guidance for selection, use and interpretation of results.<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2008<\/td>\n48<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198170,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198164","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\/198164","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\/198170"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198164"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198164"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198164"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}