- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
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)
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EU Directives are published on this site to aid cross referencing from UK legislation. Since IP completion day (31 December 2020 11.00 p.m.) no amendments have been applied to this version.
Article 2.Requirements for the procurement of human tissues and cells
Article 3.Selection criteria for donors of tissues and cells
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
Selection criteria for donors are based on an analysis of...
1.1. General criteria for exclusion
1.1.1. Cause of death unknown, unless autopsy provides information on the...
1.1.3. Presence, or previous history, of malignant disease, except for primary...
1.1.4. Risk of transmission of diseases caused by prions. This risk...
1.1.5. Systemic infection which is not controlled at the time of...
1.1.6. History, clinical evidence, or laboratory evidence of HIV, acute or...
1.1.7. History of chronic, systemic autoimmune disease that could have a...
1.1.8. Indications that test results of donor blood samples will be...
1.1.9. Evidence of any other risk factors for transmissible diseases on...
1.1.10. Presence on the donor’s body of physical signs implying a...
1.1.11. Ingestion of, or exposure to, a substance (such as cyanide,...
1.1.12. Recent history of vaccination with a live attenuated virus where...
1.2. Additional exclusion criteria for deceased child donors
1. Biological tests required for donors
1.1. The following biological tests must be performed for all donors...
1.2. HTLV-I antibody testing must be performed for donors living in,...
1.3. When anti-HBc is positive and HBsAg is negative, further investigations...
1.4. A validated testing algorithm must be applied to exclude the...
1.5. In certain circumstances, additional testing may be required depending on...
2. General requirements to be met for determining biological markers
2.1. The tests must be carried out by a qualified laboratory,...
2.2. The biological tests will be carried out on the donor’s...
2.3. When potential donors have lost blood and have recently received...
2.5. In the case of living donors (except allogeneic bone marrow...
2.6. If in a living donor (except bone marrow stem-cell and...
2.7. In the case of bone marrow and peripheral blood stem-cell...
2.8. In the case of neonatal donors, the biological tests may...
1. Donation and procurement procedures
1.2. Donor evaluation (this section does not apply to partner donation...
1.3. Procurement procedures for tissues and cells
1.3.1. The procurement procedures must be appropriate for the type of...
1.3.2. The procurement procedures must protect those properties of the tissue/cells...
1.3.3. For deceased donation, the area of access must be restricted....
1.3.5. Once the tissues and cells have been retrieved from a...
1.3.6. Any adverse event occurring during procurement that has or may...
1.3.7. Policies and procedures must be in place to minimise the...
1.3.8. Sterile instruments and devices must be used for tissue and...
1.3.9. When reusable instruments must be used, a validated cleaning and...
1.3.10. Wherever possible, only CE marked medical devices must be used...
2. Reception of the tissue/cells at the tissue establishment
2.1. When the retrieved tissues/cells arrive at the tissue establishment, there...
2.2. Each establishment must ensure that the tissue and cells received...
2.3. Each tissue establishment must have a documented policy and specifications...
2.4. The data that must be registered at the tissue establishment...
2.5. In the case of reproductive cells intended for partner donation,...
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