PD IS0/TS 81001-2-1:2025 BSl Standards Publication Health software and health IT systems safety, effectiveness and security Part 2-1: Coordination Guidance and requirements for the use of assurance cases for safety and security bsi. PD IS0/TS 81001-2-1:2025 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of IS0/TS 81001-2-1:2025. The UK participation in its preparation was entrusted to Technical Committee IST/35, Health informatics. A list of organizations represented on this committee can be obtained on request to its committee manager. Contractual and legal considerations This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law. This publication is provided as is, and is to be used at the recipient's own risk. The recipient is advised to consider seeking professional guidance with respect to its use of this publication. This publication is not intended to constitute a contract. Users are responsible for its correct application. This publication is not to be regarded as a British Standard. @ The British Standards Institution 2025 Published by BSI Standards Limited 2025 ISBN 978 0 539 17684 1 ICS 35.240.80 Compliance with a Published Document cannot confer immunity from legal obligations. This Published Document was published under the authority of the Amendments/corrigenda issued since publication Date Text affected PD IS0/TS 81001-2-1:2025 IEC Technical iso Specification IS0/TS 81001-2-1 First edition Health software and health IT 2025-01 systems safety, effectiveness and security - Part 2-1: Coordination Guidance and requirements for the use of assurance cases for safety and security Sécurité, efficacite et sureté des logiciels de santé et des systemes TI de santé- Partie 2-1: Coordination - Orientations et exigences relatives a I'utilisation des dossiers d'assurance en matiere de sureté et de sécurite Referencenumber ISO/TS 81001-2-1:2025(en) @ISO2025