ISO 15883-1:2006 洗碗消毒机具-第1部分：一般要求,术语及定义和试验

标准编号：ISO 15883-1:2006

中文名称：洗碗消毒机具-第1部分：一般要求,术语及定义和试验

英文名称：Washer-disinfectors — Part 1: General requirements, terms and definitions and tests

发布日期：2006-04

标准范围

ISO 15883-1:20 06规定了清洗消毒器（WD）及其附件的一般性能要求，这些清洗消毒器旨在用于清洁和消毒可重复使用的医疗器械和其他用于医疗、牙科、制药和兽医实践的物品。它规定了清洁和消毒以及实现必要性能所需附件的性能要求。还规定了验证、常规控制和监测以及定期和必要维修后再验证所需的方法和仪器。ISO 15883的后续部分规定了用于处理特定负载的清洗消毒器的要求。对于打算处理两种或两种以上不同类型负载的清洗消毒器，本标准所有相关部分的要求均适用。ISO 15883-1:20 06没有规定用于洗衣或一般餐饮用途的机器的要求。ISO 15883-1:20 06不包括用于对负载进行灭菌或指定为“灭菌器”的机器的要求，这些要求在其他标准（例如EN 285）中有规定。本标准规定的性能要求可能无法确保传染性海绵状脑病的病原体（朊病毒蛋白）的灭活或去除。ISO 15883-1:20 06可被潜在购买者和制造商用作WD规格协议的基础。用户也可以使用用于证明符合ISO 15883-1:20 06要求的测试方法来证明已安装的WD在其整个工作寿命期间持续符合要求。还提供了常规测试程序的指导。

ISO 15883-1:2006 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control and monitoring and re-validation, periodically and after essential repairs, are also specified.The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of ISO 15883. For washer-disinfectors intended to process loads of two or more different types the requirements of all relevant parts of this standard apply.ISO 15883-1:2006 does not specify requirements intended for machines for use for laundry or general catering purposes.ISO 15883-1:2006 does not include requirements for machines which are intended to sterilize the load, or which are designated as "sterilizers", these are specified in other standards e.g. EN 285.The specified performance requirements of this standard may not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies.ISO 15883-1:2006 may be used by prospective purchasers and manufacturers as the basis of agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of ISO 15883-1:2006 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme also is given.

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