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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 >
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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, 2007
- 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
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of AAMI adoption of ISO 11140-4:2007
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General requirements
- 5 Indicator system format
- 6 Performance requirements
- 7 Packaging and labeling
- 8 Quality assurance
- Annex A Determination of indicator strength during and after steam sterilization [Go to Page]
- Annex B Standard test cycles [Go to Page]
- 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 [Go to Page]
- Annex D Determination of uniform color change on exposure to saturated steam [Go to Page]
- Annex E Determination of equivalence of the alternative indicator to the Bowie and Dick test [Go to Page]
- Annex F Determination of reproducibility of fail conditions created in a standard test pack by air injection, air leak and retained air systems [Go to Page]
- Annex G Determination of indicator color change on exposure to dry heat [Go to Page]
- Annex H Determination of shelf life of product
- Annex I Accelerated aging of test samples
- Annex J Steam exposure apparatus and steam for test purposes [Go to Page]
- Annex K Standard test pack
- Annex L Air injection system
- Bibliography [Go to Page]
