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Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells · European Union

Tissue establishments shall take all necessary measures to ensure that the quality system includes at least the following documentation: standard operating procedures, guidelines, training and reference manuals, reporting forms, donor records, information on the final destination of tissues or cells.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.