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BS EN ISO 15194:2009

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

Summary

Classification systems;Medical specimens;Certificates of conformity;Identification methods;Marking;Experimental design;Calibration;Biological analysis and testing;Terminology;Chemical properties;Test specimens;Instructions for use;Safety measures;Diagnosis (medical);Control samples;Microbiological analysis;Reports

Technical characteristics

Publisher British Standards Institution (BSI)
Publication Date 01/31/2016
Page Count 26
Themes Reports
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