公共卫生指导：预防通过人类来源物质传播艾滋病毒的准则

Technical guidelines supporting the regulation onstandards of quality and safety for substances ofhuman origin intended for human application ECDCPUBLIC HEALTH GUIDANCE Guidelines on the prevention of HIVtransmission through substances ofhuman origin Technical guidelines supporting the regulation on standards of quality andsafety for substances of human origin intended for human application These guidelinesof the European Centre for Disease Prevention and Control (ECDC) was coordinated byFranҫois-Xavier Lamy and Jenny Mohseni Skoglund. The following internal ECDC experts contributed to the work that informed the guidelines development: Franҫois-Xavier Lamy, Nina Lagerqvist, Anastasia Pharris, Juliana Reyes-Uruena, Jenny Mohseni Skoglund, FláviaCunha, Csaba Kodmon and Vanja Nikolac Markić. Acknowledgements We would like to thank the following members of the ECDC ad hoc scientific panel for their insightful inputsupporting with evidence and expertise, reviewing the pathogen data sheet and meeting minutes, and providingstatements to the guidelines: Alessandra Alteri,IRCCS San Raffaele Scientific Institute;Italy,Alexandra Hartmann, Cells and Tissue bank,Austria;Aliénor Xhaard, Hopital St-Louis, France,Ana Avellón, National Center of Microbiology Carlos III Instituteof Health, Spain;Andreas Lind, Oslo University Hospital, Norway;Anna Vilarrodona, Banc de Sang i Teixits, Spain;Anthi Gafou, Hospital of Kifisia “Oi Agioi Anargyroi”, Greece;Branka Golubić Ćepulić, University Hospital CenterZagreb, Croatia;Danica Valkovicová Staneková, Slovak Medical University, Slovakia;Dominique Challine, HenriMondor Hospital, France;Dragoslav Domanovic, European Blood Alliance, international organisation;Jaana Mättö,University of Helsinki, Finland;Paolo Grossi, ASST-Sette Laghi, Italy;Piotr Grabarczyk, Institute of Haematologyand Transfusion Medicine, Poland;Ruth Offergeld, Robert Koch Institute, Germany;Ryanne W Lieshout-Krikke,Sanquin Blood Supply Foundation, Netherlands;Silvia Sauleda, Banc de Sang i Teixits, Spain;Syria Laperche,EtablissementFrançais du Sang,France. We would also like to thank the observers of the expert panel for their valuable input:Rada Grubovic Rastvorceva,European Directorate for the Quality of Medicines and Healthcare(EDQM),JacintoSanchez, EDQM (delegated),Richarde Forde, EDQM. Suggested citation: European Centre for Disease Prevention and Control.Guidelines on the prevention of HIVtransmission through substances of human origin.Stockholm: ECDC;2025. Stockholm,September 2025 ISBN978-92-9498-823-2doi:10.2900/6503189Catalogue numberTQ-01-25-053-EN-N Contents Abbreviations................................................................................................................................................vGlossary.......................................................................................................................................................viExecutive summary......................................................................................................................................viiKey requirements...........................................................................................................................................1Blood and blood components.................................................................................................................1Tissues and non-reproductive cells–living and deceased donors..............................................................2Reproductive cells–third party donations...............................................................................................3Reproductive tissues and cells–within partner use..................................................................................4Introduction..................................................................................................................................................5Objectives and scope..............................................................................................................................................5Target audience......................................................................................................................................................6Structure of the document......................................................................................................................................6Guidelines development..................................................................................................................................7Overall guidelines development...............................................................................................................................7Evidence synthesis..................................................................................................................................................7Expert meetings...............................................................................