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)

What 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) requires

COMMISSION DIRECTIVE 2005/62/EC implements Directive 2002/98/EC by establishing Community standards and specifications for a quality system in blood establishments. It applies to all blood establishments involved in the collection, testing, processing, storage, and distribution of human blood and blood components. The directive ensures a high level of human health protection by preventing disease transmission and maintaining equivalent quality and safety standards. It mandates the implementation of a quality system encompassing quality management, assurance, and continuous improvement, including personnel, premises, equipment, documentation, and processes. Blood establishments must comply with these standards, and imported blood components must meet equivalent quality system requirements.

Pillar: Legal & IP Sovereignty · Authority: THE COMMISSION OF THE EUROPEAN COMMUNITIES · Version: 1.0.0 · Last updated: 2005-09-30

Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32005L0062

SHA-256 integrity: aa5be7ec58b410860d510669283dea6572ff582a2c44fbd2112c12ecc456a3d6

Primary Citations — 6 traced to source

• Article 1(a): 'standard' means the requirements that serve as the basis for comparison.
• Article 1(b): 'specification' means a description of the criteria that must be fulfilled in order to achieve the required quality standard.

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