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ISO 18153 : In vitro Diagnostic Medical Devices - Measurement of Quantities in Biological Samples - Metrological Traceability of Values for Catalytic Concentration of Enzymes Assigned Calibrators and Control Materials
ISO 18153 ： In vitro Diagnostic Medical Devices - Measurement of Quantities in Biological Samples - Metrological Traceability of Values for Catalytic Concentration of Enzymes Assigned Calibrators and Control Materials
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体外診断用医療機器－生体サンプル中の量の測定－キャリブレータ及び対照物質に割り当てられた酵素の触媒濃度の値の計量学的トレーサビリティ。酵素の触媒濃度の測定の正確性を確立または検証することを目的としたキャリブレータ及び管理材料に割り当てられた値の計量学的トレーサビリティを保証する方法を示すもの。
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