ISO INTERNATIONAL STANDARD 81001-1 First edition 2021-03 Health software and health IT systems safety,effectivenessandsecurity- Part 1: Principles and concepts Sécurité, efficacite et surete des logiciels de sante et des systemes TI desanté- Partie1:Principesetconcepts Reference number TEC IS081001-1:2021(E) OSI @ISO 2021 IS081001-1:2021(E) COPYRIGHTPROTECTEDDOCUMENT IS02021 All rights reserved.Unless otherwise specified, or required in the context of its implementation,no part of this publicationmay beloworIso'smemberbodyinthecountryoftherequester. ISO copyright office CP 401:Ch.de Blandonnet 8 CH-1214Vernier,Geneva Phone:+41227490111 Email:[email protected] Website: www.iso.org Published in Switzerland @IS02021-All rights reserved

ISO 81001-1 2021 Health software and health IT systems safety, effectiveness and security — Part 1 Principles and concepts

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