ISO/NP 22860.3

Biotechnology — Unified Modeling Language (UML) metadata specifications for human mesenchymal stromal cells

Scope

This document defines the specification of hMSC metadata using a Unified Model Language (UML). It defines metadata elements, their properties, and the relationships between elements, and establishes a common set of metadata terminology and definitions procedures.

This document defines for hMSC:
- mandatory and conditional metadata sections, metadata entities, and metadata elements;
- the minimum set of metadata required to serve most UML metadata applications (data discovery, determining data fitness for use, data access, data transfer, and use of digital data and services);
- optional metadata elements to allow for a more extensive standard description of resources, if required;
- UML for extending metadata to fit specialized needs.

The UML is used to describe hMSCs resources including textual documents, initiatives, software, hMSCs specifications and repositories. When implemented this document aims to:
- Enable hMSc publishers to effectively and completely characterize their resources ;
- Facilitate the organization and management of metadata for information resources ;
- Enable appropriate use of information resources through accurate understanding of their characteristics.
- Facilitate resource discovery, access, retrieval and reuse;
- Enable subscribers to determine whether an information resource will be of use to them.

This document is applicable to applicable to organizations, authorities and industries that are:
- acquiring, collecting, processing, testing, analyzing, storing, or distributing hMSC (e.g., biobanks, laboratories, biomedical research laboratories);
- generating, collecting, analyzing, processing, or storing data on and related to hMSC (e.g., biobanks, laboratories, developers).

This document is also applicable to providers of services related to hMSC data management (e.g. regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others can use this document in confirming or recognizing the competence of the aforementioned parties).

This document does not apply to biological material and data used for medical diagnosis and therapy.

NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.