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ÖNORM EN ISO 18153:2003-11

Действует
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)
ОписаниеИзмененияСсылкиВерсии

Ссылочные документы

ÖNORM EN ISO 17511:2003-11
Действует
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

На этот документ ссылаются

DIN EN ISO 18113-2:2013-01
Действует
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2011 — 19 стр.
DIN EN ISO 18113-1:2010-05
Отменен
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2009 — 62 стр.
DIN EN ISO 18113-2:2010-05
Отменен
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009); German version EN ISO 18113-2:2009 — 22 стр.
DIN EN ISO 18113-1:2013-01
Действует
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009); German version EN ISO 18113-1:2011 — 60 стр.
DIN EN ISO 14971:2013-04
Отменен
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); German version EN ISO 14971:2012 — 112 стр.
ÖNORM EN 14136:2004-07
Действует
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
DIN EN ISO 17511:2003-11
Отменен
In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003); German version EN ISO 17511:2003 — 35 стр.