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

ISO 11140-4:2007 specifies 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).An indicator complying with ISO 11140-4:2007 incorporates a specified material which is used as a test load. This test load may, or may not, be re-usable. ISO 11140-4:2007 does not specify requirements for the test load, but specifies the performance of the indicator in combination with the test load with which it is intended to be used. The indicator specified in ISO 11140-4:2007 is intended to identify poor steam penetration but does not necessarily indicate the cause of this poor steam penetration.This part of ISO 11140-4:2007 does not include test methods to establish the suitability of these indicators for use in sterilizers in which the air removal stage does not include evacuation below atmospheric pressure.