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

Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

被代替

标准号

ISO 15883-1:2006

发布

2006年

发布单位

国际标准化组织

替代标准

ISO 15883-1:2006/Amd 1:2014

当前最新

ISO 15883-1:2006/Amd 1:2014

 

 

引用标准

IEC 60417-DB IEC 60584-1:1995 IEC 60751:1983 IEC 61010-2-045 IEC 80416-1 ISO 10012 ISO 14644-3:2005 ISO 14971 ISO 228-1 ISO 7000 ISO/TS 15883-5:2005

适用范围

This part of ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance requirements for cleaning and disinfection as well as for the accessories which can be required to achieve the necessary performance. The methods and instrumentation required for validation, routine control 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 parts of this standard. For washer-disinfectors intended to process loads of two or more different types the requirements 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 general catering purposes. This part of ISO 15883 does not include requirements for machines which are intended to sterilize the load, or which 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 the causative 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 agreement on the specification of a WD. The test methods for demonstration of compliance with the requirements of this part of ISO 15883 may also be employed by users to demonstrate continued compliance of the installed WD throughout its working life. Guidance on a routine test programme is given in Annex A.

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