ISO 15883-1-2006 洗涤消毒器.第1部分:一般要求、术语、定义和试验

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                   【英文标准名称】:     Washer-disinfectors - Part 1: General requirements, terms and definitions and tests            【原文标准名称】:     洗涤消毒器.第1部分:一般要求、术语、定义和试验            【标准号】:     ISO 15883-1-2006            【标准状态】:     现行            【国别】:     国际            【发布日期】:     2006-04    【实施或试行日期】: 【发布单位】: 国际标准化组织(IX-ISO)【起草单位】: ISO/TC 198【标准类型】: ()【标准水平】: ()【中文主题词】: 清洁设备;清洁机;控制装置;控制设备;去污染;定义;消毒器具;消毒器;电气器具;电气工程;一般条件;实验室器具;实验室器皿;测量仪器;医疗设备;压力容器;安全;安全规则;安全要求;规范(验收);试验【英文主题词】: Cleaning equipment;Cleaning machines;Control devices;Control equipment;Decontaminations;Definitions;Disinfection apparatus;Disinfectors;Electric appliances;Electrical engineering;English language;General conditions;Laboratory apparatus;Laboratory ware;Measuring instruments;Medical devices;Medical equipmenterformance requirementsressure vessels;Safety;Safety regulations;Safety requirements;Specification (approval);Testing【摘要】: This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and theiraccessories that are intended to be used for cleaning and disinfection of re-usable medical devices and otherarticles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifiesperformance requirements for cleaning and disinfection as well as for the accessories which can be requiredto achieve the necessary performance. The methods and instrumentation required for validation, routinecontrol 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 partsof this standard. For washer-disinfectors intended to process loads of two or more different types therequirements of all relevant parts of this standard apply.This part of ISO 15883 does not specify requirements intended for machines for use for laundry or generalcatering purposes.This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, orwhich 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 thecausative agent(s) (prion protein) of transmissible spongiform encephalopathies.This part of ISO 15883 may be used by prospective purchasers and manufacturers as the basis of agreementon the specification of a WD. The test methods for demonstration of compliance with the requirements of thispart of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WDthroughout its working life. Guidance on a routine test programme is given in Annex A.【中国标准分类号】: C47【国际标准分类号】: 11_080_10【页数】: 70P;A4【正文语种】: 英语         
         

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