标准摘要
[中文适用范围]： 本文件规定了空腔设备和多孔设备的性能要求和测试方法以及在这些设备中使用的化学指标和生物指标的要求。根据 EN 13060 的规定，本文件指定了 A 类蒸汽灭菌器 (B 类和某些 S 类循环) 的特定蒸汽穿透性能测试。 NOTE：本文档所述的空腔和多孔设备不用于替代医疗机构中使用的空腔和多孔医疗器械作为代用设备。 [外文原描述]： 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 indicator system equivalent in performance to the RPD, i.e. an APIS, usually commercially manufactured, of any design. b) 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 ). This document specifies the requirements for: — a reference hollow device (RHD) 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; — an alternative hollow device: — employing the same specific test load as defined for the RHD 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; — equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially manufactured, of any design.
英文名称Sterilization of health care products — Chemical indicators — Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers