Tissues And Cells (S.L. 483.1)

Съдържание

1. чл. 1 Citation and scope.
2. чл. 2 Interpretation.
3. чл. 3 Responsible person.
4. чл. 4 Duties of establishments.
5. чл. 5 Relations between tissue establishment and third parties.
6. чл. 6 Traceability.
7. чл. 7 Keeping of records and reporting obligations.
8. чл. 8 Notification of serious adverse events and reactions.
9. чл. 9 Consent.
10. чл. 10 Data protection and confidentiality.
11. чл. 11 Quality management.
12. чл. 12 Requirements for the procurement of human tissues and cells.
13. чл. 13 Selection criteria for donors of tissues and cells.
14. чл. 14 Laboratory tests required for donors.
15. чл. 15 Tissue and, or cell donation and procurement procedures and reception at the tissue establishment.
16. чл. 16 Requirements for direct distribution to the recipient of specifictissuesand cells.