{"id":198085,"date":"2024-10-19T12:36:38","date_gmt":"2024-10-19T12:36:38","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11140-1-2014\/"},"modified":"2024-10-25T05:09:51","modified_gmt":"2024-10-25T05:09:51","slug":"aami-11140-1-2014","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11140-1-2014\/","title":{"rendered":"AAMI 11140 1 2014"},"content":{"rendered":"

Specifies performance requirements for indicators that show exposure to sterilization processes by means of physical and\/or chemical change of substances.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/ISO 11140-1:2014, Sterilization of healthcare products\u2014Chemical indicators\u2014Part 1: General requirements <\/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
7<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of AAMI adoption of ISO 11140-1:2014 <\/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 <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4 Categorization
4.1 General
Table 1 \u2014 Categories according to intended use <\/td>\n<\/tr>\n
17<\/td>\n4.2 Type 1: process indicators
4.3 Type 2: indicators for use in specific tests
4.4 Type 3: single critical process variable indicators
4.5 Type 4: multicritical process variable indicators
4.6 Type 5: integrating indicators
4.7 Type 6: emulating indicators
5 General requirements <\/td>\n<\/tr>\n
20<\/td>\nFigure 1\u2014Symbol for designation for use with a specific test load only
6 Performance requirements
6.1 General
6.2 Type 1 indicators <\/td>\n<\/tr>\n
21<\/td>\n6.3 Type 2 indicators
6.4 Types 3, 4, 5 and 6 indicators
7 Test methods
7.1 General
7.2 Off-set (transference)
7.3 Procedure \u2014 Steam indicators <\/td>\n<\/tr>\n
22<\/td>\n7.4 Procedure \u2014 Dry heat indicators
7.5 Procedure \u2014 EO indicators <\/td>\n<\/tr>\n
23<\/td>\n7.6 Procedure \u2014 Low temperature steam and formaldehyde indicators
7.7 Procedure \u2014 Vaporized hydrogen peroxide indicators <\/td>\n<\/tr>\n
24<\/td>\n8 Additional requirements for process (Type 1) indicators
8.1 Process indicators printed or applied on to packaging material
8.2 Process indicators for steam sterilization processes
Table 2 \u2014 Test and performance requirements for Type 1 process indicators for
8.3 Process indicators for dry heat sterilization processes <\/td>\n<\/tr>\n
25<\/td>\n8.4 Process indicators for ethylene oxide sterilization processes
Table 4 \u2014 Test and performance requirements for Type 1 process indicators for
8.5 Process indicators for radiation sterilization processes <\/td>\n<\/tr>\n
26<\/td>\nTable 5 \u2014 Test and performance requirements for Type 1 process indicators for IRRAD
8.6 Process indicators for low temperature steam and formaldehyde sterilization processes
Table 6 \u2014 Test conditions and performance requirements for Type 1 process indicators for FORM <\/td>\n<\/tr>\n
27<\/td>\n8.7 Process indicators for vaporized hydrogen peroxide sterilization processes
Table 7 \u2014 Test conditions and performance requirements for Type 1 process indicators for
9 Additional requirements for single critical process variable (Type 3) indicators
10 Additional requirements for multicritical process variable (Type 4) indicators <\/td>\n<\/tr>\n
28<\/td>\nTable 8 \u2014 Test and performance requirements for Type 3 and Type 4 indicators
11 Additional requirements for steam integrating (Type 5) indicators <\/td>\n<\/tr>\n
29<\/td>\n12 Additional requirements for ethylene oxide integrating (Type 5) indicators
Table 9 \u2014 Test and performance requirements for Type 5 indicators
13 Additional requirements for emulating (Type 6) indicators <\/td>\n<\/tr>\n
30<\/td>\nTable 10 \u2014 Test and performance requirements for Type 6 indicators <\/td>\n<\/tr>\n
31<\/td>\nAnnex A: Method for demonstrating shelf-life of the product <\/td>\n<\/tr>\n
32<\/td>\nAnnex B: Examples of testing indicators
B.1 Example of testing single critical process variable (Type 3) indicator for dry heat processes
B.2 Example of testing multicritical process variable indicator for steam processes
B.3 Example of testing emulating (Type 6) indicators for steam processes <\/td>\n<\/tr>\n
33<\/td>\nAnnex C: Rationale for the requirements for integrating indicators and the link to the requirements for biological indicators specified in ISO 11138 (all parts) and microbial inactivation
C.1 Steam
C.1.1 General
C.1.2 Background information <\/td>\n<\/tr>\n
34<\/td>\nFigure C.1\u2014Type 5 plot <\/td>\n<\/tr>\n
35<\/td>\nC.2 The link between the integrating indicator SV and BI inactivation
C.2.1 Accept or pass (end point attained) criteria
C.2.2 Reject or fail (end point not attained) criteria <\/td>\n<\/tr>\n
36<\/td>\nC.3 The response of the integrating indicator at different temperatures and the relationship to the biological indicator’s z-value <\/td>\n<\/tr>\n
37<\/td>\nC.4 Ethylene oxide <\/td>\n<\/tr>\n
39<\/td>\nAnnex D: Rationale for the liquid-phase test method for low temperature steam and formaldehyde indicators
D.1 General
D.2 The low temperature steam and formaldehyde process
D.3 Chemical indicators <\/td>\n<\/tr>\n
40<\/td>\nAnnex E: Relationship of indicator and indicator system components
Figure E.1 \u2014 Relationship of indicator and indicator system components <\/td>\n<\/tr>\n
41<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11140-1:2014 – Sterilization of health care products – Chemical indicators – Part 1: General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2014<\/td>\n41<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198088,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198085","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\/198085","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\/198088"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198085"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198085"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198085"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}