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ISO/DIS 9491-1 Viešoji apklausa

Komentavimo iki data 2025-09-27

Biotechnologija. Kompiuterinių prognozavimo modelių taikymas atliekant individualizuotosios medicinos tyrimus. 1 dalis. Modelių sudarymas, tikrinimas ir patvirtinimas

This document specifies requirements and recommendations for the design, development and implementation of predictive computational models for research purposes in the field of personalized medicine and health product development. It addresses the set-up, formatting, validation, simulation, storing and sharing of computational models used for personalized medicine. Requirements and recommendations for data used to construct or required for validating such models are also addressed. This includes rules for formatting, descriptions, annotations, interoperability, integration, access and provenance of such data. This document does not apply to computational models used for standard routine clinical, diagnostic or therapeutic purposes.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 23494-1 Viešoji apklausa

Komentavimo iki data 2025-09-16

Biotechnologija. Kilmės informacijos modelis, skirtas biologinei medžiagai ir duomenims. 1 dalis. Modelio kūrimo sąvokos ir bendrieji reikalavimai

This document specifies a general concept for provenance information of biological material and data, organizational roles, and requirements for provenance information management. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: a) acquiring, collecting, processing, testing, analyzing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); b) generating, collecting, analyzing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); c) generating, collecting, analyzing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain). d) Manufacturing devices or software for the afore mentioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). Customers, 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, treatment and therapy. NOTE 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

ISO/DIS 23494-2 Viešoji apklausa

Komentavimo iki data 2025-09-15

Biotechnologija. Kilmės informacijos modelis, taikomas biologinei medžiagai ir duomenims. 2 dalis. Bendrasis kilmės informacijos modelis

This document specifies a common model for generating, maintaining, and provisioning provenance information on objects, such as biological material and data. This document also specifies requirements for provenance information serialization to achieve its interoperability. The provenance information covers any information relevant to the traceability, quality and fitness for purpose of the biological material and data generated throughout the life cycle of the biological material from collection to analysis, including data originating from analytical procedures applied to the biological material and further processing of the data. This document is applicable to organizations, authorities and industries that are: a) acquiring, collecting, processing, testing, analyzing, storing, or distributing biological material in biotechnology and biomedicine (e.g., biobanks, laboratories, biomedical research as well as biotechnological development or production); b) generating, collecting, analyzing, processing, or storing data on and related to biological material (e.g., biobanks, laboratories, developers, manufacturers, or other institutions and commercial organizations in biotechnology or biomedicine); c) generating, collecting, analyzing, processing, or storing data or digital objects in biotechnology and biomedicine (e.g., in vitro/in vivo/in silico diagnostics developers and manufacturers, or other institutions and commercial organizations in the domain). d) Manufacturing devices or software for the afore mentioned tasks or providing facilities for these tasks. This document is also applicable to providers of services related to provenance information management (e.g., provenance information generation, storage, provision, or validation). Customers, 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 1 This document can be applied by organizations performing laboratory or research activities as well as other activities in biotechnology and biomedicine. NOTE 2 International, national, or regional regulations or requirements can also apply to specific topics covered in this document.

Skaityti, komentuoti projektą Peržiūrėti metaduomenis

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ICS