ISO/TS 5568:2022 PDF

Name: ISO/TS 5568:2022 — Health informatics — Traditional Chinese medicine — Labelling metadata of human biological sample information
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Health informatics — Traditional Chinese medicine — Labelling metadata of human biological sample information

Название (английский):

ISO/TS 5568:2022

Health informatics — Traditional Chinese medicine — Labelling metadata of human biological sample information

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 3 ноября 2022 г.
Издание:: ISO TS 5568 edition 1 version 1
ICS:: 35.240.80

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Описание (английский):

This document defines the metadata elements to accurately and consistency label clinical information in traditional Chinese medicine human biological samples. Animal biological samples are outside the scope of this document. This document is not applicable for bioinformatics labelling of biological samples. Human biological samples obtained to support the clinical application of biomedical products of human origin are outside the scope of this document.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TS 5568:2022 - Health informatics - Traditional Chinese medicine - Labelling metadata of human biological sample information - defines a standardized set of metadata elements for labelling human biological samples used in Traditional Chinese Medicine (TCM). The specification focuses on accurate, consistent clinical information labelling to reduce information loss (for example, missing TCM syndrome or constitution data) and to improve data exchange, sharing and reuse across biobanks, research repositories and clinical systems.

Scope highlights

Covers metadata for human biological samples in TCM contexts.

Excludes animal samples, bioinformatics-only labelling, and samples used to support clinical application of biomedical products of human origin.

Key topics and technical requirements

Structure: Metadata is organized into two main parts - an Identification subset and a Content information subset.

Standard table of metadata: Sections and elements include:

Identification: dataset name, identifier, publisher, keywords, language.
Sample information labelling:
- Demographic (sex, date of birth, occupation, ID, address, contact).
- Basic (material type - e.g., whole blood, plasma, DNA; processing time; security level; coding system).
- Collecting & distribution (collection method/time/personnel, reception time, transport mode, distribution method).
- Storage (storage address, method, container/equipment, signs/labels, delivery/destruction time and method).
Clinical information labelling:
- Medical history (past diseases, exposures, constitution).
- Observation information (four examinations: inspection, listening/smelling, inquiry, palpation - e.g., tongue and pulse images).
- Diagnoses in TCM (disease and syndrome differentiation) and biomedicine (disease/pathology).
- Intervention methods (TCM interventions, biomedical interventions, physical therapy).

Element dictionary & obligations: Each metadata element is defined with descriptions and obligation status (Mandatory, Conditional, Optional) to guide consistent implementation.

Encoding examples: Coding schemes and sample ID formats (example CHOP-IT-1800910-BS-F-02) are provided to illustrate structured identifiers.

Applications and users

Who benefits:

Biobanks and sample repositories building TCM-focused collections.

TCM researchers and clinical investigators needing complete, semantically consistent sample annotation.

Health informatics architects, EHR/laboratory system integrators implementing interoperable metadata schemas.

Standards bodies and data governance teams harmonizing cross-site data exchange.

Practical uses:

Enabling interoperable TCM biobank data for multi-center studies and precision medicine.

Preserving TCM-specific clinical details (syndrome differentiation, constitution) that are often lost in biomedical labelling.

Supporting sample traceability, quality control, storage lifecycle and lawful destruction.

Related standards

Standards referenced or relevant for implementation include ISO/TC 215 outputs and related standards cited in the specification, such as:

Keywords: ISO/TS 5568:2022, traditional Chinese medicine, TCM metadata, labelling metadata, biological samples, health informatics, biobank, sample labelling, clinical information, data interoperability.

ISO/TS 5568:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

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