《ISO 10993-1-2016》.pdf 28页

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    INTERNATIONAL ISO STANDARD 10993-1 Fourth edition 2009-10-15 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process Évaluation biologique des dispositifs médicaux — Partie 1: Évaluation et essais au sein d'un processus de gestion du risque Reference number ISO 10993-1:2009(E) © ISO 2009 ISO 10993-1:2009(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. COPYRIGHT PROTECTED DOCUMENT © ISO 2009 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elect

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