Sterilization. Steam sterilizers. Large sterilizers
消毒 蒸汽灭菌器 大型灭菌器
发布日期:
2021-11-09
本文件规定了主要用于医疗保健的大型蒸汽灭菌器的要求和相关试验,用于对包含在一个或多个灭菌模块中的医疗器械及其附件进行灭菌。本文件中所述的试验负荷是为了代表大多数负荷(即由金属、橡胶和多孔材料组成的包装货物),用于评估医疗器械用通用蒸汽灭菌器。然而,特定负载(例如重金属物体或长和/或窄内腔)将需要使用其他测试负载。包括以下内容:
BS EN 285:2015BS EN 285:2015BS EN 285:2015BS EN 285:2015
This document specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this document are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.Incorporates the following:BS EN 285:2015BS EN 285:2015BS EN 285:2015BS EN 285:2015