SN EN 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 labelling
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 colour of the substrate and of the
        changed or unchanged indicator system by
        determination of relative reflectance density
Annex D (normative) Determination of uniform colour 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 colour change
        on exposure to dry heat
Annex H (normative) Determination of shelf life of product
Annex I (normative) Accelerated ageing 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

Describes the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads).