BS EN ISO 23640-2011

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

发布日期：2012-06-30  实施日期：2012-06-30

BS EN ISO 23640-2013

在体外诊断医疗设备 稳定性评价的体外诊断试剂

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

发布日期：2013-03-31  实施日期：2013-03-31

EN ISO 18153-2003

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials ISO 18153:2003

实施日期：2003-08-01

NF S92-032-2002

Stability testing of in vitro diagnostic reagents.

EN 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

实施日期：2003-08-01

EN ISO 23640-2013

体外诊断医疗器械 体外诊断试剂稳定性评估

In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents

实施日期：2013-02-01

ISO 15194-2009

体外诊断医疗器械 生物源性样品中量的测量 鉴定的参考物质的要求和支持文件的内容

In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation second edition...

发布日期：2009-04-28  实施日期：2009-05-01

NF S92-041-2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents.

NF S92-021-2004

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials.

NF S92-020-2009

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation.

DIN EN 13641-2002

试管诊断传染风险的消除或降低

Elimination or reduction of risk of infection related to in vitro diagnostic reagents; German version EN 13641:2002, German and English texts

EN 13641-2002

Elimination or Reduction of Risk of Infection Related to In Vitro Diagnostic Reagents

实施日期：2002-05-27

DIN EN ISO 18153-2003

体外诊断医疗器械 生物试样数量的测量 检定员和对照材料所赋酶量催化浓度值的计量溯源性

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control m...

DIN 58934-1-1997

血像监控材料.第1部分:监控血液

Haematology - Control material for the CBC - Part 1: Control bloods

NF S92-022-2004

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials.

DIN EN ISO 23640-2013

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

发布日期：2013-09-01  实施日期：2013-09-01

BS EN ISO 15194-2009

In-Vitro-Diagnostika. Messung von Gr??en in Proben biologischen Ursprungs-Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt der Begleitdokumentation In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation Dispositifs médicaux de diagnostic in vitro. Mesurage des grandeurs dans les échantillons d'origine biologique. Exigences relatives aux matériaux

实施日期：2009-05-31

ISO 18153-2003

体外诊断医疗器械 生物试样数量的测量 检定员和对照材料所赋酶量催化浓度值的计量溯源性

In vitro diagnostic medical devices measurement of quantities in biological samples metrological aceability of values for catalytic concentration of enzymes assigned to calibrators and control material...

实施日期：2003-08-15

ISO 17511-2003

体外诊断医疗器械 生物试样数量的测定 对检定员和对照材料赋值的计量溯源性

In vitro diagnostic medical devices measurement of quantities in biological samples metrological traceability of values assigned to calibrators and control materials first edition

实施日期：2003-08-15

BS EN ISO 18153-2003

体外诊断医疗器械 生物试样数量的测量 分配给校准器和控制材料的酶催化浓度值的计量溯源性

In-vitro-Diagnostika. Messung von Groessen in Proben biologischen Ursprungs. Metrologische Rueckfuehrbarkeit von Werten der katalytischen Konzentration von Enzymen,die Kalibratoren und Kontrollmaterial...

实施日期：2003-08-19