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ISO 2018. Biological evaluation of medical devices —. Part 1: 10993-1. Fifth edition. 2018-08. Reference number. ISO 10993-1:2018(E). Corrected version. ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, provides. 890.pdf data.consilium.europa.eu/doc/document/ST-. 10728-2016-INIT/en/pdf ISO 10993-1: Biological evaluation of medical devices – Part 1:. COPYRIGHT PROTECTED DOCUMENT. © ISO 2018. All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of thisThis corrected version of ISO 10993-1:2018 incorporates the following correction. —In Table A.1, 6th column, “Sensitization” has been added as a table heading. ISO 10993-1 was prepared by Technical Committee ISO/TC 194, Biological evaluation of medical devices. This fourth edition cancels and replaces the third edition Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.