This Directive shall apply to the collection and testing of human blood and blood components, whatever their intended purpose, and to their processing, storage, and distribution when intended for transfusion.

Where blood and blood components are collected and tested for the sole purpose and exclusive use in autologous transfusion and are clearly identified as such, the requirements to be complied with in respect thereof shall be in accordance with those referred to in Article 29(g).

This Directive does not apply to blood stem cells.