ISO 15883-4:2018 清洗消毒器 第4部分：采用化学消毒不耐热内窥镜的清洗消毒器的要求和试验
标准编号：ISO 15883-4:2018
中文名称：清洗消毒器 第4部分：采用化学消毒不耐热内窥镜的清洗消毒器的要求和试验
英文名称：Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
发布日期：2018-11
标准范围
本文件规定了特殊要求，包括清洗消毒器（WD）的性能标准，该清洗消毒器用于不耐热内窥镜的清洗和化学消毒。本文件还规定了清洗消毒器及其部件和附件的清洗和消毒性能要求，这些部件和附件可能需要达到必要的性能标准。还规定了型式试验、工程试验、验证（首次安装时的安装、运行和性能鉴定）、常规控制和监测以及WD定期和基本维修后再鉴定所需的方法、仪器和说明。注1:此外，附件A为本文件所涵盖的活动范围的适当责任划分提供了指导。注2:符合本文件要求的WD也可用于清洁和化学消毒其他不耐热可重复使用的医疗器械，设备制造商已推荐并验证了该消毒方法。符合本文件要求的WD不适用于医疗设备的清洁和消毒，包括热稳定的内窥镜附件，可通过热方法进行消毒或灭菌（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传染性海绵状脑病病原体（朊蛋白）的灭活或去除。注3:如果认为可能存在朊蛋白，则在选择清洁剂和消毒剂时需要特别小心，以确保使用的化学品不会与朊蛋白和/或其他蛋白质发生反应，从而抑制其从负载或清洗消毒器中去除或失活。注4:潜在购买者和制造商可将本文件用作WD规范、内窥镜、清洁产品和消毒产品制造商协议的基础。
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.
标准预览图
