AAMI 11140 4 2007 RA 2015
$115.49
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
| Published By | Publication Date | Number of Pages |
| AAMI | 2007 | 48 |
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)
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | 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 |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Background of AAMI adoption of ISO 11140-4:2007 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions |
| 15 | 4 General requirements |
| 16 | 5 Indicator system format 6 Performance requirements |
| 18 | 7 Packaging and labeling |
| 20 | 8 Quality assurance |
| 21 | Annex A Determination of indicator strength during and after steam sterilization A.1 Apparatus A.2 Procedure |
| 23 | Annex B Standard test cycles |
| 24 | B.2 Cycle 2: Air removal by trans-atmospheric pulsing |
| 25 | B.3 Cycle 3: Air removal by super-atmospheric pulsing |
| 26 | B.4 Acceptance limits during steam admission |
| 28 | Annex 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 |
| 29 | C.3 Test method C.3.1 Sample conditioning C.3.2 Procedure |
| 30 | C.4 Test report |
| 32 | Annex D Determination of uniform color change on exposure to saturated steam D.1 Apparatus D.2 Procedure |
| 33 | Annex E Determination of equivalence of the alternative indicator to the Bowie and Dick test E.1 Principle E.2 Apparatus E.3 Procedure |
| 35 | Annex 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 |
| 36 | F.2.3 No fault condition |
| 37 | F.3 Statistical evaluation of reproducibility |
| 39 | Annex G Determination of indicator color change on exposure to dry heat G.1 Apparatus G.2 Procedure G.2.1 General |
| 40 | Annex H Determination of shelf life of product |
| 41 | Annex I Accelerated aging of test samples |
| 42 | Annex 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 |
| 43 | J.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 |
| 44 | J.5 Steam supply |
| 45 | Annex K Standard test pack |
| 46 | Annex L Air injection system |
| 48 | Bibliography |
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