欧盟医疗器械指令 MDD9342EEC培训

液和组织)在体外进行检查,以提供下列信息为唯一或主要目的,这些目的是:-生理或病理状态;-先天畸形状况;-确定安全性和对可能接受人的相容性;-监察治疗措施.样本容器也被认为是体外诊断医疗器械.Note1:IVDD98/79/ECNote2:导尿管Vs尿杯8第1章定义和范围定制器械:根据医生或其他专业人士的书面要求,为某一特定患者而制造的任何器械.‘custom-madedevice’ordancewithadulyqualifiedmedicalpractitioner'swrittenprescriptionwhichgives,underhisresponsibility,specificdesigncharacteristicsandisintendedforthesoleuseofaparticularpatient.Note1:Mass-produceddeviceswhichneedtobeadaptedtomeetthespecificrequirementsofthemedicalpractitioneroranyotherprofessionaluser►M5shallnotbe◄consideredtobecustommadedevices大量生产则不应认为是定制器械9第1章定义和范围临床调查用器械:指合法执业医务人员在特定医疗场所进行附录X规定的任何器械.‘deviceintendedforclinicalinvestigation’meansanydeviceintendedforusebyadulyqualifiedmedicalpractitionerwhenconductinginvestigationsasreferredtoinSection2.1ofAnnexXinanadequatehumanclinicalenvironment.10