MT · S.L. 483.1
Tissues And Cells (S.L. 483.1)
Inhoud
- Art. 1 Citation and scope.
- Art. 2 Interpretation.
- Art. 3 Responsible person.
- Art. 4 Duties of establishments.
- Art. 5 Relations between tissue establishment and third parties.
- Art. 6 Traceability.
- Art. 7 Keeping of records and reporting obligations.
- Art. 8 Notification of serious adverse events and reactions.
- Art. 9 Consent.
- Art. 10 Data protection and confidentiality.
- Art. 11 Quality management.
- Art. 12 Requirements for the procurement of human tissues and cells.
- Art. 13 Selection criteria for donors of tissues and cells.
- Art. 14 Laboratory tests required for donors.
- Art. 15 Tissue and, or cell donation and procurement procedures and reception at the tissue establishment.
- Art. 16 Requirements for direct distribution to the recipient of specifictissuesand cells.