ISO 17511:2003 规定了如何确保分配给校准器和控制材料的值的计量可追溯性,旨在建立或验证测量的真实性。 校准品和对照材料由制造商提供,作为体外诊断医疗设备的一部分或与体外诊断医疗设备一起使用。 具有经过验证的可互换性的外部质量评估(调查)样品,其值已通过国际商定的参考测量系统或国际商定的常规参考测量系统分...
标准号:ISO 17511:2003 EN 标准名称:体外诊断医疗器械 生物样本中数量的测量 校准物和控制材料所赋值的计量溯源性 英文名称:In vitro diagnostic medical devices — Measurement of quantities in biological samples — Metrological traceability of values assigned to calibrators and control materials ...
DIN EN ISO 17511:2003-11
体外诊断医疗设备.生物试样中的数量测量.校准器和控制材料赋予值的测量可追踪性 ISO 17511-2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials ISO 17511:2003 ...
DIN EN ISO 17511 2003 《DIN EN ISO 17511-2003》由会员分享,可在线阅读,更多相关《DIN EN ISO 17511-2003(35页珍藏版)》请在人人文库网上搜索。 DEUTSCHENORMNOVEMBER2003INVITRODIAGNOSTIKAMESSUNGVONGRENINPROBENBIOLOGISCHENURSPRUNGSMETROLOGISCHERCKFHRBARKEITVONWERTEN,DIEKALIBRIERMATERIALIENUNDKONTROLLMATERIALIEN...
EN ISO 17511 体外诊断医疗装置 生物样品的定量测量 已知校正器及控制材料值的计量跟踪性 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) EN ISO 18153 体外诊断医疗装置...
【英语版】国际标准 ISO 17511:2020 EN 体外诊断医疗器械 建立校准器、真实性控制材料和人体样本分配值的计量可追溯性的要求 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.pdf 1页内容...
EN ISO 17511-2003体外诊断医疗装置生物样品的定量测量已知校正器及控制材料值的计量跟踪性In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003) ...
BSENISO17511:2021BRITISHSTANDARD Nationalforeword ThisBritishStandardistheUKimplementationofENISO17511:2021. ItisidenticaltoISO17511:2020.ItsupersedesBSENISO17511:2003, whichiswithdrawn. TheUKparticipationinitspreparationwasentrustedtoTechnical CommitteeCH/212,IVDs. ...
BSI Standards PublicationIn vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samplesBS EN ISO 17511:2021