Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements

This document specifies a general concept for a provenance information model for biological material and data and requirements for provenance data interoperability and serialization. The provenance information model covers any information relevant to the quality and fitness for purpose of the biological material generated throughout the preanalytical phase of the materials life cycle from collection to analysis, data originating from analytical procedures applied to the biological material and results from further mathematical processing of the data. This document is applicable to organizations, authorities and industries that are: a) collecting, processing or distributing biological material for research; b) generating, collecting, analysing or storing data on biological material. This document does not apply to biological material and data used for other than research or in fields that are regulated by national, regional or international laws, such as medical diagnosis and therapy or food production. NOTE International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

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ISO/TS 23494-1:2023 - Biotechnology — Provenance information model for biological material and data — Part 1: Design concepts and general requirements Released:12. 04. 2023
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First edition
Biotechnology — Provenance
information model for biological
material and data —
Part 1:
Design concepts and general
Reference number
ISO/TS 23494-1:2023(E)
© ISO 2023

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ISO/TS 23494-1:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
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  © ISO 2023 – All rights reserved

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ISO/TS 23494-1:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements and recommendations on provenance information management .3
4.1 Provenance information generation . 3
4.2 Provenance information availability and findability . 5
4.3 Provenance information accessibility . 6
4.4 Requirements for the computer infrastructure . 6
Bibliography . 7
© ISO 2023 – All rights reserved

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ISO/TS 23494-1:2023(E)
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