本文件规定了用于证明清洗消毒器（WD）及其附件的清洗效果的程序和测试方法，这些清洗消毒器及其附件用于清洗可重复使用的医疗器械。 注？1？本要求适用于与医疗、牙科、实验室、制药和兽医实践中使用的其他物品一起使用的清洗消毒器。 注2:本文件不适用于可重复使用医疗器械制造商开展的活动。

This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of reusable medical devices. NOTE？1？The requirements can be used for washer-disinfectors intended for use with other articles used in the context of medical, dental, laboratory, pharmaceutical and veterinary practice. NOTE？2？This document does not apply to the activities to be performed by the manufacturers of reusable medical devices.