ISO 15883-4:2008 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 15883-4:2008

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：2008-05

标准范围

ISO 15883-4:2008规定了清洗消毒器（WD）的特殊要求，包括性能，这些清洗消毒器用于不耐热内窥镜的清洗和化学消毒。ISO 15883-4:2008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。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、监测和再验证所需的方法、仪器和说明，以及定期和基本维修后的方法、仪器和说明。ISO 15883-4:2008可供潜在购买者和制造商使用，作为内窥镜、清洁产品、消毒产品制造商规范的基础，也可供用户使用。

ISO 15883-4:2008 specifies the particular requirements, including performance, for washer-disinfectors (WDs) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.ISO 15883-4:2008 also specifies the performance requirements for the cleaning and disinfection of the washer-disinfector and its components and accessories which may be required to achieve the necessary performance.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 re-validation, periodically and after essential repairs, are also specified.ISO 15883-4:2008 can be used by prospective purchasers and manufacturers as the basis of agreement on the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and also by users.

标准预览图