Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23... (32006L0017)
Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (Text with EEA relevance)
- COMMISSION DIRECTIVE 2006/17/EC
- of 8 February 2006
- implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells
- (Text with EEA relevance)
- Article 1
- Definitions
- Article 2
- Requirements for the procurement of human tissues and cells
- Article 3
- Selection criteria for donors of tissues and cells
- Article 4
- Laboratory tests required for donors
- Article 5
- Tissue and/or cell donation and procurement procedures and reception at the tissue establishment
- Article 6
- Requirements for direct distribution to the recipient of specific tissues and cells
- Article 7
- Transposition
- Article 8
- Entry into force
- Article 9
- Addressees
- ANNEX I
- SELECTION CRITERIA FOR DONORS OF TISSUES AND/OR CELLS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 3(a)
- 1. Deceased Donors
- 1.1. General criteria for exclusion
- 1.2. Additional exclusion criteria for deceased child donors
- 2. Living donors
- 2.1. Autologous living donor
- 2.2. Allogeneic living donor
- ANNEX II
- LABORATORY TESTS REQUIRED FOR DONORS (EXCEPT DONORS OF REPRODUCTIVE CELLS) AS REFERRED TO IN ARTICLE 4(1)
- 1. Biological tests required for donors
- 2. General requirements to be met for determining biological markers
- ANNEX III
- SELECTION CRITERIA AND LABORATORY TESTS REQUIRED FOR DONORS OF REPRODUCTIVE CELLS AS REFERRED TO IN ARTICLE 3(b) AND ARTICLE 4(2)
- 1. Partner donation for direct use
- 2. Partner donation (not direct use)
- 3. Donations other than by partners
- 4. General requirements to be met for determining biological markers
- ANNEX IV
- CELL AND/OR TISSUE DONATION AND PROCUREMENT PROCEDURES AND RECEPTION AT THE TISSUE ESTABLISHMENT AS REFERRED TO IN ARTICLE 5
- 1. Donation and procurement procedures
- 1.1. Consent and donor identification
- 1.2. Donor evaluation (this section does not apply to partner donation of reproductive cells or to autologous donors)
- 1.3. Procurement procedures for tissues and cells
- 1.4. Donor documentation
- 1.5. Packaging
- 1.6. Labelling of the procured tissues/cells
- 1.7. Labelling of the shipping container
- 2. Reception of the tissue/cells at the tissue establishment
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