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ISO 18153:2003

Действует
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 — 18 стр.
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На этот документ ссылаются

PD IEC/TS 62720:2013
Заменен
Identification of units of measurement for computer-based processing — 266 стр.
BS EN ISO 18113-2:2011
Действует
In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling). In vitro diagnostic reagents for professional use — 24 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 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 — 26 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 14136:2004
Действует
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures — 14 стр.
BS EN ISO 14971:2012
Действует
Medical devices. Application of risk management to medical devices — 104 стр.
BS EN ISO 15195:2003
Действует
Laboratory medicine. Requirements for reference measurement laboratories — 24 стр.
ÖNORM EN ISO 15195:2004-01
Заменен
Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
ÖNORM EN ISO 15195:2019-06
Действует
Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures (ISO 15195:2018)
ÖNORM EN ISO 15194:2009-09
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 (ISO 15194:2009)