SR EN ISO 11140-6:2022

This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the chemical indicators and biological indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers according to EN 13060. NOTE      The hollow and porous devices described in this document are not intended for use as surrogate devices for hollow and porous medical devices used in health care facilities. a)    Chemical indicators used with a porous device specified in this document are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060). This document specifies the requirements for: —    a reference porous device (RPD) as a reference device by which alternative porous indicator systems (APISs) can be shown to be equivalent in performance according to this document, i.e. a textile test pack in which steam penetration is judged by thermometric means; —    an alternative porous chemical indicato