ANNEX IV

Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC · European Union

BASIC TESTING REQUIREMENTS FOR WHOLE BLOOD AND PLASMA DONATIONS The following tests must be performed for whole blood and apheresis donations, including autologous predeposit donations: ABO Group (not required for plasma intended only for fractionation) Rh D Group (not required for plasma intended only for fractionation) testing for the following infections in the donors: Hepatitis B (HBs-Ag) Hepatitis C (Anti-HCV) HIV 1/2 (Anti-HIV 1/2) Additional tests may be required for specific components or donors or epidemiological situations.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-05 · Text as adopted (Official Journal); later amendments are not incorporated in this text.