【英文标准名称】:Cardiovascularimplantsandartificialorgans-Haemodialysers,haemodiafilters,haemofiltersandhaemoconcentrators
【原文标准名称】:心血管植入物和人造器官.血液透析器、血液透析过滤器、血液过滤器和血液浓缩器
【标准号】:ISO8637-2004
【标准状态】:作废
【国别】:国际
【发布日期】:2004-10
【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/TC150
【标准类型】:()
【标准水平】:()
【中文主题词】:血液;定义;渗析;血液透析过滤器;血液透析器;血透析设备;血液过滤器;作标记;医疗设备;医学科学;包装件;规范;测试;试验
【英文主题词】:Blood;Definitions;Dialysis;Haemodiafiltration;Haemodialysers;Haemodialysisequipment;Haemofiltration;Marking;Medicalequipment;Medicalsciences;Packages;Specifications;Testing;Tests
【摘要】:ThisInternationalStandardspecifiesrequirementsforhaemodialysers,haemodiafilters,haemofiltersandhaemoconcentrators,hereinaftercollectivelyreferredtoas"thedevice",foruseforhumans.ThisInternationalStandardisnotapplicableto—extracorporealbloodcircuits,—plasmafilters,—haemoperfusiondevices,—vascularaccessdevices,—bloodpumps,—pressuremonitorsfortheextracorporealbloodcircuit,—airdetectiondevices,—systemstoprepare,maintainormonitordialysate,—systemsusedtoperformhaemodialysis,haemodiafiltration,haemofiltrationorhaemoconcentration,—reprocessingproceduresandequipment.NOTERequirementsfortheextracorporealbloodcircuitforhaemodialysers,haemodiafilters,andhaemofiltersarespecifiedinISO8638.
【中国标准分类号】:C45
【国际标准分类号】:11_040_40
【页数】:17P;A4
【正文语种】:英语