{"id":198157,"date":"2024-10-19T12:36:53","date_gmt":"2024-10-19T12:36:53","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11140-4-2007-ra-2015\/"},"modified":"2024-10-25T05:10:05","modified_gmt":"2024-10-25T05:10:05","slug":"aami-11140-4-2007-ra-2015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11140-4-2007-ra-2015\/","title":{"rendered":"AAMI 11140 4 2007 RA 2015"},"content":{"rendered":"

Specifies performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick test for steam sterilizers for wrapped health care goods (instruments, etc. and porous loads)<\/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\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 11140-4:2007\/(R)2015, Sterilization of health care products – Chemical indicators – Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/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>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
10<\/td>\nBackground of AAMI adoption of ISO 11140-4:2007 <\/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 <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
15<\/td>\n4 General requirements <\/td>\n<\/tr>\n
16<\/td>\n5 Indicator system format
6 Performance requirements <\/td>\n<\/tr>\n
18<\/td>\n7 Packaging and labeling <\/td>\n<\/tr>\n
20<\/td>\n8 Quality assurance <\/td>\n<\/tr>\n
21<\/td>\nAnnex A Determination of indicator strength during and after steam sterilization
A.1 Apparatus
A.2 Procedure <\/td>\n<\/tr>\n
23<\/td>\nAnnex B Standard test cycles <\/td>\n<\/tr>\n
24<\/td>\nB.2 Cycle 2: Air removal by trans-atmospheric pulsing <\/td>\n<\/tr>\n
25<\/td>\nB.3 Cycle 3: Air removal by super-atmospheric pulsing <\/td>\n<\/tr>\n
26<\/td>\nB.4 Acceptance limits during steam admission <\/td>\n<\/tr>\n
28<\/td>\nAnnex C Estimation of visual difference between color of the substrate and of the changed or unchanged indicator system by determination of relative reflectance density
C.1 Principle
C.2 Apparatus <\/td>\n<\/tr>\n
29<\/td>\nC.3 Test method
C.3.1 Sample conditioning
C.3.2 Procedure <\/td>\n<\/tr>\n
30<\/td>\nC.4 Test report <\/td>\n<\/tr>\n
32<\/td>\nAnnex D Determination of uniform color change on exposure to saturated steam
D.1 Apparatus
D.2 Procedure <\/td>\n<\/tr>\n
33<\/td>\nAnnex E Determination of equivalence of the alternative indicator to the Bowie and Dick test
E.1 Principle
E.2 Apparatus
E.3 Procedure <\/td>\n<\/tr>\n
35<\/td>\nAnnex F Determination of reproducibility of fail conditions created in a standard test pack by air injection, air leak and retained air systems
F.1 General
F.2 Criteria for acceptability of test cycles
F.2.1 General
F.2.2 Reference fault condition <\/td>\n<\/tr>\n
36<\/td>\nF.2.3 No fault condition <\/td>\n<\/tr>\n
37<\/td>\nF.3 Statistical evaluation of reproducibility <\/td>\n<\/tr>\n
39<\/td>\nAnnex G Determination of indicator color change on exposure to dry heat
G.1 Apparatus
G.2 Procedure
G.2.1 General <\/td>\n<\/tr>\n
40<\/td>\nAnnex H Determination of shelf life of product <\/td>\n<\/tr>\n
41<\/td>\nAnnex I Accelerated aging of test samples <\/td>\n<\/tr>\n
42<\/td>\nAnnex J Steam exposure apparatus and steam for test purposes
J.1 General
J.2 Instrumentation
J.2.1 General
J.2.2 Indicator, controller, and recorder sensors
J.2.3 Calibration <\/td>\n<\/tr>\n
43<\/td>\nJ.3 Cycle control
J.3.1 Steam control
J.3.2 Air detector
J.3.3 Signals
J.4 Operating cycle stages and control limits required
J.4.1 Cycle stages
J.4.2 Control limits <\/td>\n<\/tr>\n
44<\/td>\nJ.5 Steam supply <\/td>\n<\/tr>\n
45<\/td>\nAnnex K Standard test pack <\/td>\n<\/tr>\n
46<\/td>\nAnnex L Air injection system <\/td>\n<\/tr>\n
48<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11140-4:2007\/(R)2015 – Sterilization of health care products – Chemical indicators – Part 4: Class 2 indicators as an alternative to Bowie and Dick test for detection of steam penetration<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2007<\/td>\n48<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198160,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198157","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\/198157","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\/198160"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198157"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198157"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198157"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}