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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, 2024
- 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
- Title page
- AAMI Standard
- Copyright information
- Contents
- Committee representation
- Background of ANSI/AAMI adoption of ISO 11140-6:2022
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Requirements [Go to Page]
- 4.1 General
- 4.2 Porous devices [Go to Page]
- 4.2.1 Reference porous device (RPD)
- 4.2.2 Detector for reference porous device (RPD) [Go to Page]
- Figure 1 — Location of temperature sensors
- 4.2.3 Alternative porous indicator system (APIS)
- 4.2.4 Reference porous device (RPD) response [Go to Page]
- 4.2.4.1 Reference porous device (RPD) pass response
- 4.2.4.2 Reference porous device (RPD) fail response
- 4.3 Hollow devices [Go to Page]
- 4.3.1 Reference hollow device (RHD)
- 4.3.2 Detector for reference hollow device (RHD) [Go to Page]
- Table 1 — Biological indicator specification
- 4.3.3 Reference hollow indicator system (RHIS)
- 4.3.4 Reference hollow indicator system (RHIS) performance determination [Go to Page]
- Figure 2 — Determination of characteristic vacuum pressure change points during testing of modified air removal
- 4.3.5 Leakage test
- 4.4 Alternative hollow indicator system (AHIS) [Go to Page]
- 4.4.1 General
- 4.5 Alternative hollow devices intended for multiple use [Go to Page]
- Table 2 — Schedule of test cycles for alternative hollow indicator system (AHIS)
- 4.6 Test procedure for validation of conformance of the alternative hollow device to the reference hollow device (RHD)
- 5 Chemical indicator dry heat performance [Go to Page]
- 5.1 General
- 5.2 Test 1
- 5.3 Test 2
- 6 Marking and labelling [Go to Page]
- 6.1 Device labelling
- 6.2 Additional labelling requirements for hollow devices
- 6.3 Chemical indicators for use in hollow devices
- Annex A (normative) Test method for performance of reference hollow indicator system (RHIS) [Go to Page]
- A.1 Steam exposure apparatus and steam quality for test purposes [Go to Page]
- A.1.1 General
- A.1.2 Leakage test
- A.1.3 Apparatus warm-up
- A.1.4 Instrumentation [Go to Page]
- A.1.4.1 General
- A.1.4.2 Indicator, controller and recorder sensors
- A.1.4.3 Calibration
- A.1.5 Cycle control [Go to Page]
- 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
- A.1.7 Control limits
- A.1.8 Steam supply
- A.2 Test cycles [Go to Page]
- A.2.1 Cycle 1, air removal by sub-atmospheric pulsing, slow [Go to Page]
- Figure A.1 — Cycle 1, sub-atmospheric air removal, slow pressure change rate
- A.2.2 Cycle 2, trans-atmospheric pulsing, fast [Go to Page]
- 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 [Go to Page]
- Figure A.3 — Air removal by combined sub- and super-atmospheric pulsing
- A.2.4 Acceptance limits during steam admission [Go to Page]
- Figure A.4 — Acceptance limits during steam admission
- A.3 Test methods [Go to Page]
- A.3.1 Exposure time [Go to Page]
- A.3.1.1 General
- A.3.1.2 Conditioning of reference hollow load device (RHD) and detector
- A.3.2 Method for determination of pass conditions
- A.3.3 Method for determination of conditions for fail through modified air removal stage
- Annex B (normative) Test method for performance of alternative porous indicator system (APIS) [Go to Page]
- B.1 Apparatus
- B.2 Pass cycle 1 — Sub-atmospheric air removal [Go to Page]
- Figure B.1 — Standard test cycle — Sub-atmospheric air removal (see B.2)
- B.3 Pass cycle 2 — Super-atmospheric air removal [Go to Page]
- 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
- Annex C (normative) Test method for performance of alternative hollow indicator system (AHIS) [Go to Page]
- C.1 Apparatus
- C.2 Method — Pass cycle
- C.3 Method — Fail cycle
- Annex D (informative) Relationship between chemical indicator components [Go to Page]
- Figure D.1 — Relationship of chemical indicator components (from ISO 11140-1:2014, Annex E)
- Annex E (normative) Reference hollow device (RHD) [Go to Page]
- Figure E.1 — Reference hollow device (RHD) with receptacle cap removed
- Figure E.2 — Assembled reference hollow device (RHD)
- Figure E.3 — Reference hollow device (RHD) receptacle pin and receptacle cap dimensions
- Annex F (informative) Accelerated ageing of test samples
- Annex G (informative) Evaluation of reference hollow devices (RHDs) — Interlaboratory results [Go to Page]
- G.1 General
- G.2 Background
- G.3 Summary of sequential interlaboratory study results [Go to Page]
- G.3.1 Interlaboratory study 1
- G.3.2 Interlaboratory study 2
- G.3.3 Interlaboratory study 3
- G.3.4 Interlaboratory study 4
- G.3.5 Supplementary study results
- G.3.6 Interlaboratory study 5
- G.4 Summary of interlaboratory test results [Go to Page]
- G.4.1 General
- G.4.2 Outcome of interlaboratory study 5 for Cycle 1 [Go to Page]
- 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 [Go to Page]
- Table G.3 — Interlaboratory results for pass and fail conditions using cycle 2 and the reference PCD (with biological indicators)
- 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 [Go to Page]
- 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)
- 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 [Go to Page]
- 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 [Go to Page]
- Table G.8 — Cycle 2 pass condition air leak
- G.4.6.4 Cycle 2 alternative PCD [Go to Page]
- Table G.9 — Cycle 2 pass and fail condition air leak window
- G.4.6.5 Cycle 3 reference PCD [Go to Page]
- Table G.10 — Cycle 3 pass condition air leak
- G.4.6.6 Cycle 3 alternative PCD [Go to Page]
- Table G.11 — Cycle 3 pass and fail condition air leak window
- Bibliography [Go to Page]
