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作废 EN 867-5:2001
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Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S 用于灭菌器的非生物系统 - 第5部分:用于小型灭菌器性能测试的指示器系统和过程挑战装置的规范B型和S型
发布日期: 2001-08-29
实施日期: 2001-08-29
本欧洲标准规定了非生物指示器系统的性能要求和测试方法,包括其旨在运行的过程挑战设备,用于测试小型蒸汽灭菌器B型或S型的蒸汽渗透性能,适当。规定的测试系统仅适用于符合prEN 13060-2的小型蒸汽灭菌器B,并且具有大于10 l的可用室空间,并且适用于符合prEN 13060-4标准的小型蒸汽灭菌器S也具有可用的室空间大于5升。 非生物指示器系统和关联过程挑战装置被指定用于各种类型的负载。可能的负载被分为两类:可以包装或展开的多孔载荷,也可以包裹或展开的空心仪器载荷。 本欧洲多孔载荷标准的相关部分规定了以下要求: - 用于小型蒸汽灭菌器中多孔载荷的小负荷试验中使用的标准过程挑战装置; - 用于多孔载荷过程挑战装置的指示器系统。用于此目的的指示器是EN 867-1中所述的B类指示器。 - 采用交替的指标
This European Standard specifies the performance requirements and test methods for non-biological indicator systems, including the process challenge devices within which they are intended to function, to be used for testing the steam penetration performance of small steam sterilizers, Type B or Type S where ap-propriate. The test systems specified are intended for use only in small steam sterilizers Type B conforming to prEN 13060-2 and having a usable chamber space greater than 10 l and for small steam sterilizers Type S conforming to prEN 13060-4 also having a usable chamber space greater than 5 l. Non-biological indicator systems and the associate process challenge devices are specified for various types of load. The possible loads are considered in two classes: Porous loads, which can be wrapped or unwrapped, or hollow instrument loads, which also can be wrapped or unwrapped. The relevant section of this European Standard on porous loads specifies the requirements for: - a standard process challenge device to be used in the small load test for porous loads in small steam sterilizers; - an indicator system for use in the porous load process challenge device. An indicator for this purpose is a Class B indicator as described in EN 867-1. - an indicator employing an alternative process challenge device equivalent to the porous load process challenge device. The relevant section of this European Standard on hollow instruments specifies the requirements for: - hollow load process challenge devices to be used to simulate hollow instrument loads as defined in prEN 13060-4; - an indicator system, for use in one of the hollow load process challenge device, for assessing steam penetration in a wrapped load of hollow instruments. An indicator for this purpose is a Class B indicator as described in EN 867-1. The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to accommodate the proces
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归口单位: CEN/TC 102-
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