AAMI ISO 11140-4 : 2007 : R2012

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 (normative) Determination of indicator strength
        during and after steam sterilization
Annex B (normative) Standard test cycles
Annex C (normative) Estimation of visual difference between
        color of the substrate and of the changed or
        unchanged indicator system by determination of
        relative reflectance density
Annex D (normative) Determination of uniform color change
        on exposure to saturated steam
Annex E (normative) Determination of equivalence of the
        alternative indicator to the Bowie and Dick test
Annex F (normative) Determination of reproducibility of fail
        conditions created in a standard test pack by air
        injection, air leak, and retained air systems
Annex G (normative) Determination of indicator color change
        on exposure to dry heat
Annex H (normative) Determination of shelf life of product
Annex I (normative) Accelerated aging of test samples
Annex J (normative) Steam exposure apparatus and steam
        for test purposes
Annex K (normative) Standard test pack
Annex L (normative) Air injection system
Bibliography

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 (e.g., instruments and porous loads).