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Home>BS EN ISO 15194:2009

BS EN ISO 15194:2009

Standard Number
BS EN ISO 15194:2009
Title
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for certified reference materials and the content of supporting documentation
Status
Current
Publication Date
31 May 2009
Cross References
ISO 31, ISO 5725-2, ISO 17511:2003, ISO 18153, ISO Guide 31, ISO Guide 34, ISO Guide 35, ISO/IEC Guide 98-3:2008, GUM:1995, ISO/IEC Guide 99:2007, ISO 13485, ISO 14971, ISO 15193, ISO 15195, ISO/IEC 17025, ISO 18113-2, ISO/IEC Guide 15, ISO Guide 30, ISO Guide 32, ISO Guide 33, ISO/IEC Guide 51, ISO/IEC Guide 63, ISO/IEC Directives Part 1:2008, ISO/IEC Directives Part 2:2004, EN 980, EA-04/14, 98/79/EC
Replaces
BS EN 12287:1999

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Descriptors
Diagnosis (medical), Biological analysis and testing, Microbiological analysis, Medical specimens, Test specimens, Control samples, Calibration, Classification systems, Terminology, Identification methods, Reports, Chemical properties, Experimental design, Safety measures, Instructions for use, Marking, Certificates of conformity
Title in French
Dispositifs mdicaux de diagnostic in vitro. Mesurage des grandeurs dans les chantillons dorigine biologique. Exigences relatives aux matriaux de rfrence certifis et au contenu de la documentation associe
Title in German
In-Vitro-Diagnostika. Messung von Gren in Proben biologischen Ursprungs - Anforderungen an zertifizierte Referenzmaterialien und an den Inhalt der Begleitdokumentation
Pages
26
File Size
771.6 KB
Price
140.00

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