Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy— 64 стр.
Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment— 43 стр.
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 5: In vitro diagnostic instruments for self-testing— 16 стр.
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 4: In vitro diagnostic reagents for self-testing— 18 стр.
In vitro diagnostic medical devices -- Information supplied by the manufacturer (labelling) -- Part 1: Terms, definitions and general requirements— 56 стр.
In vitro diagnostic medical devices -- Measurement of quantities in biological samples -- Metrological traceability of values assigned to calibrators and control materials— 31 стр.
Accuracy (trueness and precision) of measurement methods and results - Part 3: Intermediate measures of the precision of a standard measurement method— 36 стр.
Accuracy (trueness and precision) of measurement methods and results. Part 2. Basic method for the determination of repeatability and reproducibility of a standard measurement method— 52 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2011— 17 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009); German version EN ISO 18113-5:2009— 18 стр.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2011— 20 стр.
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.
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009); German version EN ISO 18113-4:2009— 21 стр.
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.
