Publicité
The blood transport boxes do not contain magnetic materials or any sources of electromagnetic
l
or radio energy, and therefore they do not pose any risks of electromagnetic or radio
interference with other devices.
2.4.4 Indications
Blood transport boxes are devices intended for the safe transport and temporary storage of
l
whole blood and blood components (e.g., blood cells, platelets, or frozen plasma) used in the
clinical medicine for diagnosis, prevention and treatment of diseases or injuries.
During a maximum transit time of 24 hours, the temperature of blood components intended to
l
be used for transfusion, like leucocyte-depleted whole blood and red cells, must at no time
exceed +10°C or drop to freezing temperatures. Temperature excursions above +10°C
increases the risk of sepsis due to bacterial contamination, while freezing increases the risk of
rupture of the red cells (haemolysis).
Frozen plasma must be stored below -25°C. The storage temperature may rise above -20°C on
l
one or more occasions during storage but the plasma is nevertheless considered suitable for
fractionation if all the following conditions are fulfilled:
the total period of time during which the temperature exceeds -20°C does not exceed
l
72h.
the temperature does not exceed -15°C on more than one occasion.
l
the temperature at no time exceeds -5°C.
l
During transport without agitation, platelet components must be kept between 20°C and 24°C
l
for a maximum period of 24 hours before use. The impact of transport conditions on the quality
of platelet components should be validated by appropriate quality control tests.
2.4.5 Contraindications
The blood transport boxes are not intended to long term storage of blood or blood components.
l
The devices are not intended to be operated outside the environmental and installation
l
conditions documented in the operating instructions.
The devices are not intended to be used for cooling of blood or blood components.
l
Blood transport boxes are not intended to be used for cooling or transportation of foodstuffs.
l
2.4.6 Classification
As the transport of blood or blood components is considered as a temporary storage
condition, the blood transport boxes are classified as a Medical Devices Class lla according to
Regulation (EU) 2017/745. They are not medical devices according to FDA CDRH.
2. Important Information
11
Publicité
