ISO 17593-2007 临床实验室测试和体外医疗装置.口服抗凝血剂治疗自测用体外监测系统的要求

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【英文标准名称】:Clinicallaboratorytestingandinvitromedicaldevices-Requirementsforinvitromonitoringsystemsforself-testingoforalanticoagulanttherapy
【原文标准名称】:临床实验室测试和体外医疗装置.口服抗凝血剂治疗自测用体外监测系统的要求
【标准号】:ISO17593-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-04
【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/TC212
【标准类型】:()
【标准水平】:()
【中文主题词】:血凝固;临床测试;门诊部;定义;体外的;生产者检查;使用说明;体外诊断的;实验室;实验室测试;测量;测量系统;医学科学;监控;病人;人员;产品信息;质量保证;可靠度;危险;安全;规范(验收);监督(认可);治疗学;培训;用户信息;维生素K
【英文主题词】:Bloodcoagulation;Clinicaltesting;Clinics;Definitions;Invitro;Inspectionbyproducer;Instructionsforuse;In-vitrodiagnostic;Laboratories;Laboratorytesting;Measurement;Measuringsystems;Medicalsciences;Monitoring;Patients;Personnel;Productinformation;Qualityassurance;Reliability;Risk;Safety;Specification(approval);Surveillance(approval);Therapeutics;Training;Userinformation;VitaminK
【摘要】:ThisInternationalStandardspecifiesrequirementsforinvitromeasuringsystemsforself-monitoringofvitamin-Kantagonisttherapy,includingperformance,qualityassuranceandusertrainingandproceduresfortheverificationandvalidationofperformancebytheintendedusersunderactualandsimulatedconditionsofuse.ThisInternationalStandardpertainssolelytoprothrombintimemeasuringsystemsusedbyindividualsformonitoringtheirownvitamin-Kantagonisttherapy,andwhichreportresultsasinternationalnormalizedratios(INR).ThisInternationalStandardisapplicabletomanufacturersofsuchsystemsandthoseotherorganizations(e.g.,regulatoryauthoritiesandconformityassessmentbodies)havingtheresponsibilityforassessingtheperformanceofthesesystems.ThisInternationalStandarddoesnot--pertaintoinvitromeasuringsystemsforcoagulationquantitiesassessingvitamin-Kantagonisttherapyusedbyphysiciansorhealthcareproviders,--provideacomprehensiveevaluationofallpossiblefactorsthatcouldaffecttheperformanceofthesesystems,or--addressthemedicalaspectsoforal-anticoagulationtherapy.
【中国标准分类号】:C30
【国际标准分类号】:11_100_10;11_100_20
【页数】:54P.;A4
【正文语种】:英语