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ISO 15194:2009

Действует
In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation — 24 стр.
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На этот документ ссылаются

BS EN ISO 17034:2016
Действует
General requirements for the competence of reference material producers — 36 стр.
BS EN ISO 18113-1:2011
Действует
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling). Terms, definitions and general requirements — 62 стр.
BS EN ISO 15193:2009
Действует
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures — 30 стр.
BS EN ISO 15189:2012
Действует
Medical laboratories. Requirements for quality and competence — 62 стр.
PD CEN/TS 15968:2010
Действует
Determination of extractable perfluorooctanesulphonate (PFOS) in coated and impregnated solid articles, liquids and fire fighting foams. Method for sampling, extraction and analysis by LCqMS or LC-tandem/MS — 36 стр.
PD ISO GUIDE 33:2015
Действует
Reference materials. Good practice in using reference materials — 40 стр.
BS EN ISO/IEC 17025:2017
Действует
General requirements for the competence of testing and calibration laboratories — 38 стр.
18/30332771 DC
Действует
BS EN ISO 15195. Laboratory medicine. Requirements for the competence of calibration laboratories using reference measurement procedures — 16 стр.
BS ISO 15198:2004
Действует
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer — 18 стр.
ÖNORM EN ISO 15193:2009-09
Действует
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
ÖNORM EN ISO 15195:2019-06
Действует
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)