Guide to the quality and safety of tissues and cells for human application 5th ed., 2022

Format:

Corporate Author:

European Directorate for the Quality of Medicines and Healthcare

Publisher:

Council of Europe

Human tissues and cells are being used in an increasing variety of ways, and advances in transplantation therapy have unquestionable benefits. Human cells and tissues for transplantation can save lives or restore essential functions, but the use of human tissues and cells also raises questions of safety and quality. Only tissues and cells recovered, processed and stored following strict quality and safety standards are likely to function satisfactorily. Careful evaluation of donors is essential to minimise the risk of transmission of infections or malignancies. Furthermore, since human tissues and cells can currently only be derived from the body of a person, strong ethical principles need to be associated with their donation and use.The Council of Europe approaches tissue and cell transplantation in compliance with the principles of non-commercialisation and voluntary donation of materials of human origin. This 5th Edition of the Guide to the quality and safety of tissues and cells for human application contains information and guidance for all professionals involved in donation, banking, transplantation and other clinical applications of these medical products of exceptional nature. For matters dealing with the use of organs and blood or blood products, see the Council of Europe Guide to the quality and safety of organs for transplantation and Guide to the preparation, use and quality assurance of blood components, respectively