{"id":457360,"date":"2024-10-20T09:50:45","date_gmt":"2024-10-20T09:50:45","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-11140-6-2024\/"},"modified":"2024-10-26T18:17:47","modified_gmt":"2024-10-26T18:17:47","slug":"aami-11140-6-2024","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-11140-6-2024\/","title":{"rendered":"AAMI 11140 6 2024"},"content":{"rendered":"

This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060.<\/p>\n

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1<\/td>\nANSI\/AAMI\/ISO 11140-6:2024; Sterilization of health care products\u2014Chemical indicators\u2014Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard <\/td>\n<\/tr>\n
5<\/td>\nCopyright information
Contents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nBackground of ANSI\/AAMI adoption of ISO 11140-6:2022 <\/td>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope <\/td>\n<\/tr>\n
12<\/td>\n2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4 Requirements
4.1 General <\/td>\n<\/tr>\n
14<\/td>\n4.2 Porous devices
4.2.1 Reference porous device (RPD)
4.2.2 Detector for reference porous device (RPD) <\/td>\n<\/tr>\n
15<\/td>\nFigure 1 \u2014 Location of temperature sensors
4.2.3 Alternative porous indicator system (APIS) <\/td>\n<\/tr>\n
16<\/td>\n4.2.4 Reference porous device (RPD) response
4.2.4.1 Reference porous device (RPD) pass response
4.2.4.2 Reference porous device (RPD) fail response
4.3 Hollow devices
4.3.1 Reference hollow device (RHD) <\/td>\n<\/tr>\n
17<\/td>\n4.3.2 Detector for reference hollow device (RHD)
Table 1 \u2014 Biological indicator specification <\/td>\n<\/tr>\n
18<\/td>\n4.3.3 Reference hollow indicator system (RHIS)
4.3.4 Reference hollow indicator system (RHIS) performance determination
Figure 2 \u2014 Determination of characteristic vacuum pressure change points during testing of modified air removal <\/td>\n<\/tr>\n
19<\/td>\n4.3.5 Leakage test
4.4 Alternative hollow indicator system (AHIS)
4.4.1 General <\/td>\n<\/tr>\n
20<\/td>\n4.5 Alternative hollow devices intended for multiple use
Table 2 \u2014 Schedule of test cycles for alternative hollow indicator system (AHIS) <\/td>\n<\/tr>\n
22<\/td>\n4.6 Test procedure for validation of conformance of the alternative hollow device to the reference hollow device (RHD) <\/td>\n<\/tr>\n
24<\/td>\n5 Chemical indicator dry heat performance
5.1 General
5.2 Test 1
5.3 Test 2
6 Marking and labelling
6.1 Device labelling <\/td>\n<\/tr>\n
25<\/td>\n6.2 Additional labelling requirements for hollow devices
6.3 Chemical indicators for use in hollow devices <\/td>\n<\/tr>\n
26<\/td>\nAnnex A (normative) Test method for performance of reference hollow indicator system (RHIS)
A.1 Steam exposure apparatus and steam quality for test purposes
A.1.1 General
A.1.2 Leakage test
A.1.3 Apparatus warm-up <\/td>\n<\/tr>\n
27<\/td>\nA.1.4 Instrumentation
A.1.4.1 General
A.1.4.2 Indicator, controller and recorder sensors
A.1.4.3 Calibration
A.1.5 Cycle control
A.1.5.1 Steam control
A.1.5.2 Signals
A.1.5.3 Leak valve
A.1.6 Operating cycle: Stages and control options required <\/td>\n<\/tr>\n
28<\/td>\nA.1.7 Control limits
A.1.8 Steam supply
A.2 Test cycles
A.2.1 Cycle 1, air removal by sub-atmospheric pulsing, slow <\/td>\n<\/tr>\n
29<\/td>\nFigure A.1 \u2014 Cycle 1, sub-atmospheric air removal, slow pressure change rate
A.2.2 Cycle 2, trans-atmospheric pulsing, fast <\/td>\n<\/tr>\n
30<\/td>\nFigure A.2 \u2014 Cycle 2, trans-atmospheric fractionation, fast pressure change rate
A.2.3 Cycle 3, air removal by combined sub- and super-atmospheric pulsing <\/td>\n<\/tr>\n
31<\/td>\nFigure A.3 \u2014 Air removal by combined sub- and super-atmospheric pulsing
A.2.4 Acceptance limits during steam admission <\/td>\n<\/tr>\n
32<\/td>\nFigure A.4 \u2014 Acceptance limits during steam admission
A.3 Test methods
A.3.1 Exposure time
A.3.1.1 General
A.3.1.2 Conditioning of reference hollow load device (RHD) and detector <\/td>\n<\/tr>\n
33<\/td>\nA.3.2 Method for determination of pass conditions
A.3.3 Method for determination of conditions for fail through modified air removal stage <\/td>\n<\/tr>\n
34<\/td>\nAnnex B (normative) Test method for performance of alternative porous indicator system (APIS)
B.1 Apparatus
B.2 Pass cycle 1 \u2014 Sub-atmospheric air removal <\/td>\n<\/tr>\n
35<\/td>\nFigure B.1 \u2014 Standard test cycle \u2014 Sub-atmospheric air removal (see B.2)
B.3 Pass cycle 2 \u2014 Super-atmospheric air removal <\/td>\n<\/tr>\n
36<\/td>\nFigure B.2 \u2014 Standard test cycle \u2014 Super-atmospheric air removal (see B.3)
B.4 Cycle 3 \u2014 Impaired sub-atmospheric air removal
B.5 Cycle 4 \u2014 Impaired super-atmospheric air removal
B.6 Cycle 5 \u2014 Air injection <\/td>\n<\/tr>\n
37<\/td>\nAnnex C (normative) Test method for performance of alternative hollow indicator system (AHIS)
C.1 Apparatus
C.2 Method \u2014 Pass cycle
C.3 Method \u2014 Fail cycle <\/td>\n<\/tr>\n
38<\/td>\nAnnex D (informative) Relationship between chemical indicator components
Figure D.1 \u2014 Relationship of chemical indicator components (from ISO 11140-1:2014, Annex E) <\/td>\n<\/tr>\n
40<\/td>\nAnnex E (normative) Reference hollow device (RHD)
Figure E.1 \u2014 Reference hollow device (RHD) with receptacle cap removed
Figure E.2 \u2014 Assembled reference hollow device (RHD) <\/td>\n<\/tr>\n
41<\/td>\nFigure E.3 \u2014 Reference hollow device (RHD) receptacle pin and receptacle cap dimensions <\/td>\n<\/tr>\n
42<\/td>\nAnnex F (informative) Accelerated ageing of test samples <\/td>\n<\/tr>\n
43<\/td>\nAnnex G (informative) Evaluation of reference hollow devices (RHDs) \u2014 Interlaboratory results
G.1 General
G.2 Background
G.3 Summary of sequential interlaboratory study results
G.3.1 Interlaboratory study 1 <\/td>\n<\/tr>\n
44<\/td>\nG.3.2 Interlaboratory study 2
G.3.3 Interlaboratory study 3
G.3.4 Interlaboratory study 4 <\/td>\n<\/tr>\n
45<\/td>\nG.3.5 Supplementary study results
G.3.6 Interlaboratory study 5
G.4 Summary of interlaboratory test results
G.4.1 General
G.4.2 Outcome of interlaboratory study 5 for Cycle 1 <\/td>\n<\/tr>\n
46<\/td>\nTable G.1 \u2014 Interlaboratory study results for pass and fail conditions using cycle 1 and the reference PCD (with biological indicators)
Table G.2 \u2014 Interlaboratory study results for pass and fail conditions using cycle 1 and an alternative PCD (with chemical indicators)
G.4.3 Outcome of interlaboratory study 5 for Cycle 2
Table G.3 \u2014 Interlaboratory results for pass and fail conditions using cycle 2 and the reference PCD (with biological indicators) <\/td>\n<\/tr>\n
47<\/td>\nTable G.4 \u2014 Interlaboratory study results for pass and fail conditions using cycle 2 and the alternative PCD (with chemical indicators)
G.4.4 Outcome of interlaboratory study 5 for Cycle 3
Table G.5 \u2014 Interlaboratory study results for pass and fail conditions using cycle 3 using reference PCD (with biological indicators)
Table G.6 \u2014 Interlaboratory study results for pass and fail conditions on cycle 3 and the alternative PCD (with chemical indicators) <\/td>\n<\/tr>\n
48<\/td>\nG.4.5 Analysis of interlaboratory study 5 for Cycle 1 to Cycle 3
G.4.6 Analysis of interlaboratory study for cycle 1 to cycle 3 with air leaks
G.4.6.1 Cycle 1 reference PCD
Table G.7 \u2014 Cycle 1 fail condition air leak
G.4.6.2 Cycle 1 alternative PCD
G.4.6.3 Cycle 2 reference PCD <\/td>\n<\/tr>\n
49<\/td>\nTable G.8 \u2014 Cycle 2 pass condition air leak
G.4.6.4 Cycle 2 alternative PCD
Table G.9 \u2014 Cycle 2 pass and fail condition air leak window
G.4.6.5 Cycle 3 reference PCD
Table G.10 \u2014 Cycle 3 pass condition air leak
G.4.6.6 Cycle 3 alternative PCD
Table G.11 \u2014 Cycle 3 pass and fail condition air leak window <\/td>\n<\/tr>\n
51<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

ANSI\/AAMI\/ISO 11140-6:2024 Sterilization of health care products<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2024<\/td>\n51<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":457366,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-457360","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\/457360","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\/457366"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=457360"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=457360"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=457360"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}