AAMI 11140 3 2007 RA 2015
$93.55
ANSI/AAMI/ISO 11140-3:2007/(R)2015 – Sterilization of health care products – Chemical indicators – Part 3: Class 2 indicator systems for use in the Bowie and Dick steam penetration test
| Published By | Publication Date | Number of Pages |
| AAMI | 2007 | 35 |
Specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ ISO 11140-3: 2007/(R)2015, Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test |
| 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 11140-3:2007 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative references |
| 14 | 3 Terms and definitions 4 General requirements 5 Indicator system format 6 Performance requirements |
| 15 | 7 Packaging and labeling |
| 17 | 8 Quality assurance |
| 18 | Annex A Determination of strength after steam sterilization A.1 Apparatus A.2 Procedure |
| 19 | Annex B Estimation of visual difference between color of the substrate and the changed (or unchanged) indicator system by determination of relative reflectance density B.1 Principle B.2 Apparatus B.3 Measurement B.3.1 Illumination |
| 20 | B.3.2 Measuring instrument B.3.2.1 General B.3.2.2 Optical geometry B.3.2.3 Spectral response B.3.2.4 Calibration B.3.2.5 Background |
| 21 | B.4 Test method B.4.1 Sample conditioning B.4.2 Procedure B.5 Test report |
| 23 | Annex C Determination of indicator color change on exposure to dry saturated steam C.1 Apparatus C.2 Procedure |
| 24 | Annex D Determination of indicator color change on exposure to dry heat D.1 Apparatus D.2 Procedure |
| 25 | Annex E Accelerated aging of test samples |
| 26 | Annex F Determination of transfer of indicator to standard test pack on processing F.1 Apparatus F.2 Procedure |
| 27 | Annex G Determination of shelf life of the product |
| 28 | Annex H Steam exposure apparatus H.1 General H.2 Instrumentation H.3 Indicator, controller, and recorder sensors H.4.1 Cycle stages |
| 29 | H.4.2 Control options required |
| 30 | Annex I Determination of sensitivity of the indicator to the presence of air I.1 Apparatus I.2 Procedure |
| 32 | Annex J Air injection system |
| 34 | Annex K Standard test pack |
| 35 | Bibliography |
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