ISO/TS TECHNICAL SPECIFICATION 23565 First edition 2021-10 Biotechnology Bioprocessing General requirements and considerations for equipment systems used in the manufacturing of cells for therapeutic use Biotechnologie-Bioprocédés-Exigences et considérations genérales pour les systemes d'équipement utilises dans la fabrication de cellules a usage thérapeutique Reference number IS0/TS23565:2021(E) ISO @IS02021 IS0/TS 23565:2021(E) COPYRIGHT PROTECTED DOCUMENT @IS02021 All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, withoutpriorwrittenpermission.Permission can berequestedfrom eitherIso at theaddress below orIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 401 · Ch. de Blandonnet 8 CH-1214 Vernier, Geneva Phone: +4122 749 0111 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2021 - All rights reserved