00.98 Proposal for new project abandoned Mar 31, 2017
CEN
CEN/TC 140 In vitro diagnostic medical devices
European Norm
This standard applies to the determination of the total haemoglobin concentration in blood. It is applicable to the
analytical phase only.
In this standard, requirements for the instrumentation, measurement technique and preparation are defined. In
addition, it specifies requirements for the reagents or their dilutions, which are used for the determination of the
total haemoglobin concentration in blood.
The methods described are applicable to validate reference material and to assign values to primary calibrators.
This standard also applies to the determination of haemoglobin concentration in control materials if the lysis and
the conversion rates of the different Hb variants are similar to those in fresh blood.
ABANDON
cen:proj:60768
00.98
Proposal for new project abandoned
Mar 31, 2017