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. ed.

This part of ISO 11140 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. Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.The paper provides information on scope, normative references, terms and definitions, general requirements, indicator system format, performance requirements, packaging and labelling and quality assurance. 11 annexes report on the determination of strength after steam sterilization, the estimation of visual difference between colour of the substrate and the changed (or unchanged) indicator system by determination of relative reflectance density, the determination of indicator colour change on exposure to dry saturated steam, the determination of indicator colour change on exposure to dry heat, the accelerated ageing of test samples, the determination of transfer of indicator to standard test pack on processing, the determination of shelf life of the product, the steam exposure apparatus, the determination of sensitivity of the indicator to the presence of air, the air injection system and the standard test pack. Finally a bibliography is provided.