Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008)
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(ISO 15883-4:2008)
发布日期:
2009-06-03
废止日期:
2018-12-19
ISO 15883-4:2008规定了用于清洁和化学消毒耐热内窥镜的洗衣机消毒器(WD)的特殊要求,包括性能。
ISO 15883-4:2008还规定了清洁和消毒洗衣机消毒器及其部件和附件的性能要求,可能需要达到必要的性能。
还规定了类型测试所需的方法,仪器和说明,工作测试,验证(首次安装时的安装,操作和性能鉴定),定期监控和重新验证,定期进行必要修理。
ISO 15883-4:2008可供潜在购买者和制造商使用,作为内镜,清洁产品,消毒产品以及用户WD制造商规范协议的基础
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.