標準號：DIN EN ISO 15883-4-2009
中文標準名稱：清洗消毒器.第4部分:不耐熱的內窺鏡使用化學消毒的清洗消毒器的試驗和要求(ISO 15883-4-2008).英文版本DIN EN ISO 15883-4-2009-09
英文標準名稱：Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes (ISO 15883-4:2008); English version of DIN EN ISO 15883-4:2009-09
標準類型：C47
發布日期：1999/12/31 12:00:00
實施日期：2009/9/1 12:00:00
中國標準分類號：C47
國際標準分類號：11.080.10
引用標準：ISO 11731-2;ISO 15883-1-2006;ISO/TS 15883-1-2006;IEC 61010-2-040
適用范圍：This part of ISO 15883 specifies the particular requirements, including performance, for washer-disinfectors(WDs) that are intended to be used for cleaning and chemical disinfection of tnermolabile endoscopes.This part of ISO 15883 also specifies the performance requirements for the cleaning and disinfection of thewasher-disinfector and its components and accessories which may be required to achieve the necessaryperformance.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.NOTE 1 In addition, Annex A gives guidance on an appropriate division of responsibility for the range of activitiescovered by this part of ISO 15883.NOTE 2 WDs complying with this part of ISO 15883 can also be used for cleaning and chemical disinfection of otherthermolabile re-usable medical devices for which the device manufacturer has recommended this method of disinfectionWDs complying with the requirements of this part of ISO 15883 are not intended for cleaning and disinfectionof medical devices, including endoscopic accessories, which are heat stable and can be disinfected orsterilized by thermal methods (see ISO 15883-1:2006, 4.1.5).The specified performance requirements of this part of ISO 15883 may not ensure the inactivation or removalof the causative agent(s) (priori protein) of transmissible spongiform encephalopathies.NOTE 3 If it is considered that priori protein might be present, particular care is needed in the choice of disinfectantsand cleaning agents to ensure that the chemicals used do not react with the prion protein in a manner that may inhibit itsremoval or inactivation from the load or washer-disinfector.This part of ISO 15883 can be used by prospective purchasers and manufacturers as the basis of agreementon the specification of WD manufacturers of endoscopes, cleaning products, disinfecting products, and alsoby users.