標準號：ISO 15883-1-2006
中文標準名稱：洗滌消毒器.第1部分:一般要求、術語、定義和試驗
英文標準名稱：Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
標準類型：C47
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.10
適用范圍：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.