AAMI 11140 6 2024

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ANSI/AAMI/ISO 11140-6:2024 Sterilization of health care products

Published By	Publication Date	Number of Pages
AAMI	2024	51

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Description

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.

PDF Catalog

PDF Pages	PDF Title
1	ANSI/AAMI/ISO 11140-6:2024; Sterilization of health care products—Chemical indicators—Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers
3	Title page
4	AAMI Standard
5	Copyright information Contents
6	Committee representation
8	Background of ANSI/AAMI adoption of ISO 11140-6:2022
9	Foreword
10	Introduction
11	1 Scope
12	2 Normative references 3 Terms and definitions
13	4 Requirements 4.1 General
14	4.2 Porous devices 4.2.1 Reference porous device (RPD) 4.2.2 Detector for reference porous device (RPD)
15	Figure 1 — Location of temperature sensors 4.2.3 Alternative porous indicator system (APIS)
16	4.2.4 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)
17	4.3.2 Detector for reference hollow device (RHD) Table 1 — Biological indicator specification
18	4.3.3 Reference hollow indicator system (RHIS) 4.3.4 Reference hollow indicator system (RHIS) performance determination Figure 2 — Determination of characteristic vacuum pressure change points during testing of modified air removal
19	4.3.5 Leakage test 4.4 Alternative hollow indicator system (AHIS) 4.4.1 General
20	4.5 Alternative hollow devices intended for multiple use Table 2 — Schedule of test cycles for alternative hollow indicator system (AHIS)
22	4.6 Test procedure for validation of conformance of the alternative hollow device to the reference hollow device (RHD)
24	5 Chemical indicator dry heat performance 5.1 General 5.2 Test 1 5.3 Test 2 6 Marking and labelling 6.1 Device labelling
25	6.2 Additional labelling requirements for hollow devices 6.3 Chemical indicators for use in hollow devices
26	Annex 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
27	A.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
28	A.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
29	Figure A.1 — Cycle 1, sub-atmospheric air removal, slow pressure change rate A.2.2 Cycle 2, trans-atmospheric pulsing, fast
30	Figure A.2 — Cycle 2, trans-atmospheric fractionation, fast pressure change rate A.2.3 Cycle 3, air removal by combined sub- and super-atmospheric pulsing
31	Figure A.3 — Air removal by combined sub- and super-atmospheric pulsing A.2.4 Acceptance limits during steam admission
32	Figure A.4 — 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
33	A.3.2 Method for determination of pass conditions A.3.3 Method for determination of conditions for fail through modified air removal stage
34	Annex B (normative) Test method for performance of alternative porous indicator system (APIS) B.1 Apparatus B.2 Pass cycle 1 — Sub-atmospheric air removal
35	Figure B.1 — Standard test cycle — Sub-atmospheric air removal (see B.2) B.3 Pass cycle 2 — Super-atmospheric air removal
36	Figure B.2 — Standard test cycle — Super-atmospheric air removal (see B.3) B.4 Cycle 3 — Impaired sub-atmospheric air removal B.5 Cycle 4 — Impaired super-atmospheric air removal B.6 Cycle 5 — Air injection
37	Annex C (normative) Test method for performance of alternative hollow indicator system (AHIS) C.1 Apparatus C.2 Method — Pass cycle C.3 Method — Fail cycle
38	Annex D (informative) Relationship between chemical indicator components Figure D.1 — Relationship of chemical indicator components (from ISO 11140-1:2014, Annex E)
40	Annex E (normative) Reference hollow device (RHD) Figure E.1 — Reference hollow device (RHD) with receptacle cap removed Figure E.2 — Assembled reference hollow device (RHD)
41	Figure E.3 — Reference hollow device (RHD) receptacle pin and receptacle cap dimensions
42	Annex F (informative) Accelerated ageing of test samples
43	Annex G (informative) Evaluation of reference hollow devices (RHDs) — Interlaboratory results G.1 General G.2 Background G.3 Summary of sequential interlaboratory study results G.3.1 Interlaboratory study 1
44	G.3.2 Interlaboratory study 2 G.3.3 Interlaboratory study 3 G.3.4 Interlaboratory study 4
45	G.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
46	Table G.1 — Interlaboratory study results for pass and fail conditions using cycle 1 and the reference PCD (with biological indicators) Table G.2 — 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 — Interlaboratory results for pass and fail conditions using cycle 2 and the reference PCD (with biological indicators)
47	Table G.4 — 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 — Interlaboratory study results for pass and fail conditions using cycle 3 using reference PCD (with biological indicators) Table G.6 — Interlaboratory study results for pass and fail conditions on cycle 3 and the alternative PCD (with chemical indicators)
48	G.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 — Cycle 1 fail condition air leak G.4.6.2 Cycle 1 alternative PCD G.4.6.3 Cycle 2 reference PCD
49	Table G.8 — Cycle 2 pass condition air leak G.4.6.4 Cycle 2 alternative PCD Table G.9 — Cycle 2 pass and fail condition air leak window G.4.6.5 Cycle 3 reference PCD Table G.10 — Cycle 3 pass condition air leak G.4.6.6 Cycle 3 alternative PCD Table G.11 — Cycle 3 pass and fail condition air leak window
51	Bibliography