CHAPTER IV

PROVISIONS ON THE QUALITY AND SAFETY OF TISSUES AND CELLS

Tissue and cell reception
Article 19
1
Tissue establishments shall ensure that all donations of human tissues and cells are subjected to tests in accordance with the requirements referred to Article 28(e) and that the selection and acceptance of tissues and cells comply with the requirements referred to in Article 28(f).
2
Tissue establishments shall ensure that human tissue and cells and associated documentation comply with the requirements referred to in Article 28(f).
3
Tissue establishments shall verify and record the fact that the packaging of human tissue and cells received complies with the requirements referred to in Article 28(f). All tissues and cells that do not comply with those provisions shall be discarded.
4
The acceptance or rejection of received tissues/cells shall be documented.
5
Tissue establishments shall ensure that human tissues and cells are correctly identified at all times. Each delivery or batch of tissues or cells shall be assigned an identifying code, in accordance with Article 8.
6
Tissue and cells shall be held in quarantine until such time as the requirements relating to donor testing and information have been met in accordance with Article 15.