Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/... (32005L0062)
Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (Text with EEA relevance)
- COMMISSION DIRECTIVE
- 2005/62/EC
- of 30 September 2005
- implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments
- (Text with EEA relevance)
- Article 1
- Definitions
- Article 2
- Quality system standards and specifications
- Article 3
- Transposition
- Article 4
- Entry into force
- Article 5
- Addressees
- ANNEX
- Quality system standards and specifications
- 1. INTRODUCTION AND GENERAL PRINCIPLES
- 1.1. Quality system
- 1.2. Quality assurance
- 2. PERSONNEL AND ORGANISATION
- 3. PREMISES
- 3.1. General
- 3.2. Blood donor area
- 3.3. Blood collection area
- 3.4. Blood testing and processing areas
- 3.5. Storage area
- 3.6. Waste disposal area
- 4. EQUIPMENT AND MATERIALS
- 5. DOCUMENTATION
- 6. BLOOD COLLECTION, TESTING AND PROCESSING
- 6.1. Donor eligibility
- 6.2. Collection of blood and blood components
- 6.3. Laboratory testing
- 6.4. Processing and validation
- 6.5. Labelling
- 6.6. Release of blood and blood components
- 7. STORAGE AND DISTRIBUTION
- 8. CONTRACT MANAGEMENT
- 9. NON-CONFORMANCE
- 9.1. Deviations
- 9.2. Complaints
- 9.3. Recall
- 9.4. Corrective and preventive actions
- 10. SELF-INSPECTION, AUDITS AND IMPROVEMENTS
Feedback