洗衣机消毒器 - 第4部分:使用化学消毒用于耐热内窥镜的洗衣机消毒器的要求和测试

[中文适用范围]： 本文件规定了特殊要求，包括用于不耐热内窥镜清洁和化学消毒的清洗消毒器 (WD) 的性能标准。 本文件还规定了清洗消毒机及其组件和附件的清洁和消毒性能要求，以达到必要的性能标准。 还规定了类型测试、工程测试、验证（首次安装时的安装、操作和性能鉴定）、例行控制和监测以及 WD 定期和必要维修后重新鉴定所需的方法、仪器和说明。 注 1 此外，附件 A 为本文件涵盖的活动范围提供了适当的责任划分指南。 注 2：符合本文件的 WD 还可用于设备制造商推荐并验证此消毒方法的其他不耐热可重复使用医疗设备的清洁和化学消毒。 符合本文件要求的 WD 不适用于医疗器械的清洁和消毒，包括内窥镜配件，这些器械具有热稳定性，可以通过热方法进行消毒或灭菌（参见 ISO 15883-1:2006+Amd 1:2014， 4.1.5）。 本文件规定的性能要求不能确保灭活或去除传染性海绵状脑病的病原体（朊病毒蛋白）。 注3：如果认为可能存在朊病毒蛋白，则在选择清洁剂和消毒剂时需要特别小心，以确保所使用的化学品不会与朊病毒蛋白和/或其他蛋白质发生反应，从而抑制其发生。 从负载或清洗消毒器中移除或失活。 注 4：本文件可供潜在购买者和制造商使用，作为 WD、内窥镜、清洁产品和消毒产品制造商的规格协议的基础。 [外文原描述]： This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes. This document also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which can be required to achieve the necessary performance criteria. The methods, instrumentation and instructions required for type testing, works testing, validation (installation, operational and performance qualification on first installation), routine control and monitoring, and requalification of WD periodically and after essential repairs, are also specified. NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activities covered by this document. NOTE 2 WD complying with this document can also be used for cleaning and chemical disinfection of other thermolabile re-usable medical devices for which the device manufacturer has recommended and validated this method of disinfection. WD complying with the requirements of this document are not intended for cleaning and disinfection of medical devices, including endoscopic accessories, which are heat stable and can be disinfected or sterilized by thermal methods (see ISO 15883-1:2006+Amd 1:2014, 4.1.5). The specified performance requirements of this document do not ensure the inactivation or removal of the causative agent(s) (prion protein) of transmissible spongiform encephalopathies. NOTE 3 If it is considered that prion protein might be present, particular care is needed in the choice of cleaning agents and disinfectants to ensure that the chemicals used do not react with the prion protein and/or other protein in a manner that can inhibit its removal or inactivation from the load or washer-disinfector. NOTE 4 This document can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of the WD, manufacturers of endoscopes, cleaning products, and disinfecting products.