Sterilization of health care products — Chemical indicators — Part 3: Type 2 indicators for use in t...
ISO 11140-3:2007 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 ISO 11140-3:2007 are intended for use in combination with the standard test pack as described in EN…
Specification and demonstration of system reliability of single-use drug delivery systems
This document addresses the specification and demonstration of system reliability to successfully deliver a dose based on the potential consequence of failure (harm) of a function or action or the absence of an attribute, as part of design verification, utilizing empirical methods as well as in vitro/in silico modelling. This includes risk-based techniques to establish and support the required…
Sterilization of health care products — Chemical indicators — Part 5: Type 2 indicators for Bowie an...
ISO 11140-5:2007 specifies the requirements for Class 2 indicators for Bowie and Dick-type air removal tests used to evaluate the effectiveness of air removal during the pre-vacuum phase of pre-vacuum steam sterilization cycles.
Additionally, ISO 11140-5:2007 includes test methods and equipment used to meet these performance requirements.
