PD IS0/TS 11796:2023 BSl Standards Publication Biological evaluation of medical devices - Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices bsi. PD IS0/TS11796:2023 PUBLISHED DOCUMENT National foreword This Published Document is the UK implementation of IS0/TS 11796:2023. The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices. 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 accepted by BsI in relation to the adequacy, accuracy, completeness or 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 respecttoitsuseofthispublication 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 2023 Published by BSI Standards Limited 2023 ISBN 978 0 539 23352 0 ICS 11.100.20 Compliance with a Published Document cannot confer immunity from legal obligations. This Published Document was published under the authority of the Standards Policy and Strategy Committee on 31 August 2023. Amendments/corrigenda issued since publication Date Text affected PD IS0/TS 11796:2023 ISO/TS TECHNICAL 11796 SPECIFICATION First edition 2023-07-27 Biological evaluation of medical devices Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices Evaluation biologique des dispositifs médicaux - Guide pour les études interlaboratoires visant a démontrer I'applicabilité des méthodes in-vitro validées pour évaluer la sensibilisation cutanée des dispositifs medicaux Reference number IS0/TS 11796:2023(E) ISO @IS02023