Blood transfusion services (BTS) have the responsibility to collect blood only from donors who are at low risk for any infection that could be transmitted through transfusion and who are unlikely to jeopardize their own health by blood donation. A rigorous process to assess the suitability of prospective donors is therefore essential to protect the safety and sufficiency of the blood supply, and safeguard the health of recipients of transfusion and blood donors themselves, while ensuring that suitable donors are not deferred unnecessarily. These World Health Organization (WHO) guidelines, Blood donor selection: guidelines on assessing donor suitability for blood donation have been developed to assist blood transfusion services in countries that are establishing or strengthening national systems for the selection of blood donors1. They are designed for use by policy makers in national blood programmes in ministries of health, national advisory bodies such as national blood commissions or councils, and blood transfusion services. WHO guidance on criteria for the selection of blood donors was first published in the distance learning materials, Safe Blood and Blood Products, Module 1: Safe Blood Donation (1) in 1994. These earlier recommendations were developed on the basis of international best practice but did not have a clear evidence base. In 2009, the WHO Blood Transfusion Safety programme (WHO/BTS) convened a guideline development group (GDG) to prepare evidence-based recommendations on criteria for assessing the suitability of blood donors. The GDG also recognized the need to provide guidance on establishing national systems for blood donor selection. Details of the members of the GDG and their areas of expertise are provided in the Acknowledgements. WHO/BTS also established an external review group (ERG) to review and comment on the draft guidelines at various stages of the developmental process. The ERG comprised members of the WHO Expert Advisory Panel on Blood Transfusion Medicine and experts from WHO Collaborating Centres in Transfusion Medicine as well as directors of national blood transfusion services and blood programme managers from each WHO region (see Acknowledgements). The role of the ERG was to review the draft guidelines and advise WHO on the relevance, applicability and feasibility of the recommendations. An advanced draft was reviewed by participants and facilitators during an inter-regional workshop on blood donor selection and donor counselling for priority countries in the African and Eastern Mediterranean regions, June 2011, Nairobi, Kenya. The guidelines are presented in two parts. Part 1 (Sections 2 and 3) addresses the requirements for an effective national system for blood donor selection; policy recommendations are provided on p. 5. Part 2 provides guidance on specific criteria for blood donor selection in relation to general donor assessment, donor 1 The term “blood donors” includes donors of whole blood, red cells, platelets, plasma and other blood components, donated as whole blood and/or through apheresis. 2 medical history and risk assessment for transfusion-transmissible infections (TTI); technical recommendations on donor selection criteria are summarized on pp. 6–15 and elaborated in Sections 4 to 7. Blood donor selection: guidelines on assessing donor suitability for blood donation was developed in accordance with the WHO guidelines development process, which requires systematic review of new evidence for key questions and recommendations, as well as a consideration of programme feasibility and the cost implications of potential new recommendations. A systematic review of the published and “grey” literature was conducted covering the period 1995–2011, and also in 2012 for selected topics. Particular efforts were made to identify systematic literature reviews and evidence related specifically to blood donor selection in low- and middle-income countries. Detailed literature search strategies and the decision-making process for the formulation of recommendations are available in Annex 3. High quality evidence on which to base decisions on the suitability of prospective donors for blood donation is, however, limited or even lacking in relation to many medical conditions and risk behaviours. Where