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GOST ISO 17511-2011 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control mate.pdf

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1、 in vitro , (ISO 17511:2003, IDT) , ()INTERSTATE COUNCIL FOR STANDARDIZATION, METROLOGY AND CERTIFICATION(ISC)ISO 175112011, 1.092 . 1.22009 . , - . , , -, 1 - ()2 3 , (- 402011 29 2011 .) : ( 3166) 00497 ( 3166) 00497 BYKZKGRUTJUZUA 4 13 2011 . 1276- ISO 175112011 1 2013 .5 ISO 17511:2003 In vitro

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5、b1), - , - . - ISO 18153. ISO 17511.V ISO 175112011 in vitro , In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of valuesassigned to calibrators and control materials. 201301011 , , - . - in vitro ., ( ) -, - , . :) , ,( );b) , - , - , ;c) , ,

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关键词：: GOSTISO175112011INVITRODIAGNOSTICMEDICALDEVICESMEASUREMENTOFQUANTITIESINBIOLOGICALSAMPLESMETROLOGICALTRACEABILITYOFVALUESASSIGNEDTOCALIBRATORSANDCONTROLMATEPDF

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