UNE-EN ISO 11140-6:2023

This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the 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 that comply with EN 13060. The suitability of the hollow and porous devices described in this document as surrogate devices for hollow and porous medical devices used in health care facilities is not substantiated.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).The relevant sections of this document covering porous loads specify the requirements for:a) a reference porous device as a reference device by which alternative porous indicator systems 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;b) an alternative porous indicator system equivalent in performance to the reference porous device, i.e. an alternative porous indicator system, usually commercially manufactured, of any design.Chemical indicators used with a hollow load device specified in this document are designed to demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow load A) in small steam sterilizers (see EN 13060).The relevant sections of this document covering hollow loads specify the requirements for:a) a reference hollow device used as a reference device in this document, i.e. a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;b) an alternative hollow device:i. employing the same specific test load as defined for the reference hollow device and a chemical indicator designed specifically for use in the reference hollow test load, i.e. a lumened device with an attached capsule in which steam penetration is judged by visual examination of a chemical indicator;ii. equivalent in performance to the reference hollow device, i.e. an alternative hollow device, usually commercially manufactured, of any design.