The Guide to the preparation, use and quality assurance of blood components (“the Blood Guide”) is a compendium of widely accepted, harmonised, European standards that provide safety, efficacy and quality requirements for the preparation, use and quality control of blood components in Europe and beyond. Updated regularly as a technical appendix to Council of Europe Recommendation No. R(95)15, the Blood Guide collates current scientific information available to provide a comprehensive overview of the most recent advances and technical standards in the blood sector.

The Blood Guide also provides guiding principles to be considered for the donation of blood and blood components and includes the Good Practice Guidelines (GPG) which provide standards for the implementation of quality systems in blood establishments and, where applicable, hospital blood banks. In accordance with European Commission Directive (EU) 2016/1214, the GPG should be taken into account by EU member states in the implementation of quality systems in blood establishments.

The Blood Guide is elaborated by the ad hoc Working Group on the Blood Guide (GTS) composed of dedicated, internationally recognised experts. The GTS works under the aegis of the European Committee on Blood Transfusion (CD-P-TS), the steering committee responsible for blood transfusion activities at the Council of Europe.

The Blood Guide is intended for all professionals working in the donation, collection, testing, processing, storage, distribution and transfusion of blood and blood components, for blood establishments, hospital blood banks and healthcare and regulatory professionals in the blood sector.

What's new in the 22nd Edition?

The latest edition of the Blood Guide includes a complete review of all chapters, an in-depth revision of the Haemovigilance chapter and the addition of two new chapters, Blood components for topical use or injection and Blood supply contingency and emergency planning. Other significant changes relate to donor selection criteria (Creutzfeldt–Jakob disease, malaria, blood pressure and pulse, plasmapheresis, iron stores, donor age and insulin), along with the standardisation of terminology. All changes are documented in a change log to facilitate uptake of the new edition and are supported by background documents detailing the scientific rationale behind them.

The 22nd edition of the Blood Guide refers to Directives 2002/98/EC and 2004/23/EC, which remain in force until 7 August 2027, in accordance with the transitional provisions of Regulation (EU) 2024/1938 of the European Parliament and the Council of 13 June 2024, concerning quality and safety standards for substances of human origin.

Information

Download the information leaflet for more details on the 22nd Edition of the Blood Guide.

Download the 22nd Edition of the Blood Guide from FreePub, the EDQM's free publications platform.

Download the change log and the background documents for free.

Order the print version at the EDQM WebStore.