- Y Diweddaraf sydd Ar Gael (Diwygiedig)
- Pwynt Penodol mewn Amser (24/10/2006)
- Gwreiddiol (Fel y’i mabwysiadwyd gan yr UE)
Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (Text with EEA relevance)
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Article 3.Requirements for the accreditation, designation, authorisation or licensing of tissue establishments
Article 4.Requirements for the accreditation, designation, authorisation, licensing of tissue and cell preparation processes
Article 8.Communication of information between competent authorities and to the Commission
A. ORGANISATION AND MANAGEMENT
1. A responsible person must be appointed having qualifications and responsibilities...
2. A tissue establishment must have an organisational structure and operational...
3. Every tissue establishment must have access to a nominated medical...
4. There must be a documented quality management system applied to...
6. Agreements between tissue establishments and third parties must comply with...
7. There must be a documented system in place, supervised by...
8. In the event of termination of activities the agreements concluded...
9. There must be a documented system in place that ensures...
1. All equipment and material must be designed and maintained to...
2. All critical equipment and technical devices must be identified and...
3. New and repaired equipment must be tested when installed and...
4. Maintenance, servicing, cleaning, disinfection and sanitation of all critical equipment...
5. Procedures for the operation of each piece of critical equipment,...
1. A tissue establishment must have suitable facilities to carry out...
2. When these activities include processing of tissues and cells while...
3. Unless otherwise specified in point 4, where tissues or cells...
4. A less stringent environment than specified in point 3 may...
6. When the activities for which accreditation/designation/authorisation or licensing is sought...
7. Critical parameters (e.g. temperature, humidity, air quality) must be controlled,...
8. Storage facilities must be provided that clearly separate and distinguish...
9. The tissue establishment must have written policies and procedures for...
2. For every critical activity, the materials, equipment and personnel involved...
3. In the tissue establishments all changes to documents must be...
4. A document control procedure must be established to provide for...
6. Records must be legible and indelible and may be handwritten...
7. Without prejudice to Article 9(2), all records, including raw data,...
8. Records must meet the confidentiality requirements laid down in Article...
Information on the minimum donor/recipient data set to be kept as required in Article 9
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