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Health informatics — Information security management for remote maintenance of medical devices and medical information systems – Part 2: Implementation of an information security management system (ISMS)
Category
Technical Report
Organisation
ISO
ID
ISO/TR 11633-2:2021
Type
Standard
Version
2
Access
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Created
February 2021
This document provides a guideline for the implementation of an information-security management system by showing practical examples of risk analysis on remote maintenance services. It applies to information systems in healthcare facilities provided by vendors of medical devices or health information systems.
Health Informatics — Dynamic on-demand virtual private network for health information infrastructure
Category
Technical Report
Organisation
ISO
ID
ISO/TR 11636:2009
Type
Standard
Version
1
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Created
December 2009
This document describes the threats anticipated in a healthcare network, as well as how a dynamic on-demand VPN is applied in the healthcare field.
Health informatics — Principles of mapping between terminological systems
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12300:2014
Type
Standard
Version
1
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Status
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Created
November 2014
This document establishes and harmonises the basic principles for developing, maintaining, and using maps in healthcare. It provides guidelines for good practice to underpin the mapping process.
Health informatics — Guidelines for terminology development organizations
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12309:2009
Type
Standard
Version
1
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Status
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Created
December 2009
This document specifies the principles and processes that should be followed by developers of healthcare terminologies to support international healthcare terminology standardisation.
Health informatics — Principles and guidelines for the measurement of conformance in the implementation of terminological systems
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12310:2015
Type
Standard
Version
1
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Status
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Created
May 2015
This document provides a framework of good practices for terminology system maintenance and principles to ensure conformance for EHR systems.
Business requirements for health summary records – Part 1: Requirements
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12773-1:2009
Type
Standard
Version
1
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Status
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Created
June 2009
This document defines and describes health summary records based on a comprehensive review a series of initiatives and implementations worldwide.
Business requirements for health summary records – Part 2: Environmental scan
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12773-2:2009
Type
Standard
Version
1
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Status
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Created
June 2009
This document provides an environmental scan and descriptive information on health summary record initiatives worldwide, including lessons learned.
Knowledge management of health information standards
Category
Technical Report
Organisation
ISO
ID
ISO/TR 13054:2012
Type
Standard
Version
1
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Created
August 2012
This document describes a standards knowledge management methodology and metadata to help identify the existence of a health informatics standard, its developmental status, and its associated standards development organisation.
Health Informatics — Clinical document registry federation
Category
Technical Report
Organisation
ISO
ID
ISO/TR 13128:2012
Type
Standard
Version
1
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Status
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Created
July 2012
This document defines a logical structure for the federation of clinical document registries (CDRs) that does not require any conformance criteria. It sets out a list of basic functional recommendations and configuration parameters for CDR federations, as well as to provide several use cases.
Health informatics — Personal health records — Definition, scope and context
Category
Technical Report
Organisation
ISO
ID
ISO/TR 14292:2012
Type
Standard
Version
1
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Status
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Created
March 2012
This document gives a definition of a personal health record (PHR) to help clarify the types of records that should be called PHRs.
Health informatics — Capacity-based eHealth architecture roadmap – Part 1: Overview of national eHealth initiatives
Category
Technical Report
Organisation
ISO
ID
ISO/TR 14639-1:2012
Type
Standard
Version
1
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Status
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Created
August 2012
This document identifies the business requirements of an eHealth architecture, and provides a generic and comprehensive context description to inform architectural structuring of a health information system (HIS).
Health informatics — Capacity-based eHealth architecture roadmap – Part 2: Architectural components and maturity model
Category
Technical Report
Organisation
ISO
ID
ISO/TR 14639-2:2014
Type
Standard
Version
1
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Status
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Created
October 2014
This document provides a guide to best-practice business requirements and principles relating to information and communications technology (ICT) for the delivery and development of healthcare. It applies to countries and their subordinate health authorities that are planning or implementing ICT to support healthcare.
Health informatics — Identification of medicinal products — Core principles for maintenance of identifiers and terms
Category
Technical Report
Organisation
ISO
ID
ISO/TR 14872:2019
Type
Standard
Version
1
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Status
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Created
July 2019
This document describes the core principles and a proposed service-delivery model for terminology maintenance services in support of 5 International Standards on the Identification of Medicinal Products (IDMP).
Health informatics — Interoperability of telehealth systems and networks – Part 1: Introduction and definitions
Category
Technical Report
Organisation
ISO
ID
ISO/TR 16056-1:2004
Type
Standard
Version
1
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Status
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Created
July 2004
This document briefly introduces the interoperability of telehealth systems and networks, and defines telehealth and related terms.
Health informatics — Interoperability of telehealth systems and networks – Part 2: Real-time systems
Category
Technical Report
Organisation
ISO
ID
ISO/TR 16056-2:2004
Type
Standard
Version
1
Access
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Status
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Created
July 2004
This document focuses on the technical standards related to the real-time applications (including video, audio, and data-conferencing) and interoperability aspects of telehealth systems and networks.
Health informatics — Health informatics profiling framework
Category
Technical Report
Organisation
ISO
ID
ISO/TR 17119:2005
Type
Standard
Version
1
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Status
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Created
January 2005
This document provides a common description framework for health informatics standards artefacts – the health informatics profiling framework (HIPF).
Health informatics — Provisions for health applications on mobile/smart devices
Category
Technical Report
Organisation
ISO
ID
ISO/TR 17522:2015
Type
Standard
Version
1
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Status
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Created
August 2015
This document applies to the development of smart health applications and the support of new health businesses based on the smart devices.
Health informatics — Guidance on standards for enabling safety in health software
Category
Technical Report
Organisation
ISO
ID
ISO/TR 17791:2013
Type
Standard
Version
1
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Status
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Created
December 2013
This document provides guidance to National Member Bodies and readers by identifying a coherent set of international standards relevant to the development, implementation and use of safer health software.
Health informatics — Interoperability and compatibility in messaging and communication standards — Key characteristics
Category
Technical Report
Organisation
ISO
ID
ISO/TR 18307:2001
Type
Standard
Version
1
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Status
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Created
December 2001
This document describes a set of key characteristics to achieve interoperability and compatibility in exchanging health information between systems.
Health informatics — Guidance on health information privacy education in healthcare organizations
Category
Technical Report
Organisation
ISO
ID
ISO/TR 18638:2017
Type
Standard
Version
1
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Status
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Created
June 2017
This document provides guidance for healthcare organisations to establish and improve health information privacy education for their workforce.
Health informatics — Survey of mHealth projects in low and middle income countries (LMIC)
Category
Technical Report
Organisation
ISO
ID
ISO/TR 19231:2014
Type
Standard
Version
1
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Status
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Created
November 2014
This document surveys currently available eHealth frameworks and explores possible mobile health (mHealth) frameworks that could be used in low and middle income countries.
Health informatics — Re-usable component strategy for use case development
Category
Technical Report
Organisation
ISO
ID
ISO/TR 19669:2017
Type
Standard
Version
1
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Status
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Created
October 2017
This document specifies a methodology for developing use cases, facilitated by a dynamic catalogue of re-usable components. It includes a basic use-case template and the methods of component identification, capture, cataloguing and reuse.
Health informatics — Person-owned document repository for PHR applications and health information exchange
Category
Technical Report
Organisation
ISO
ID
ISO/TR 20055:2018
Type
Standard
Version
1
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Status
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Created
August 2018
This document describes the concept of a person-owned repository (PoR) of health documents
Health informatics — Electronic health record — Definition, scope and context
Category
Technical Report
Organisation
ISO
ID
ISO/TR 20514:2005
Type
Standard
Version
1
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Status
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Created
October 2005
This document describes a pragmatic classification of electronic health records (EHRs). It provides simple definitions for the main categories of EHR and provides supporting descriptions of the characteristics of EHRs and EHR systems.
Health informatics — Medication management concepts and definitions
Category
Technical Report
Organisation
ISO
ID
ISO/TR 20831:2017
Type
Standard
Version
1
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Created
July 2017
This document defines the various concepts and terminologies used in the pharmacy domain relating to creating medication lists from existing data.
Health informatics — Cloud computing considerations for the security and privacy of health information systems
Category
Technical Report
Organisation
ISO
ID
ISO/TR 21332:2021
Type
Standard
Version
1
Access
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Status
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Created
March 2021
This document provides an overview of security and privacy considerations for electronic health records (EHRs) in a cloud-computing service.
Health informatics — Security requirements for archiving of electronic health records — Guidelines
Category
Technical Report
Organisation
ISO
ID
ISO/TR 21548:2010
Type
Standard
Version
1
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Status
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Created
February 2010
This document provides additional guidance for the implementation of the requirements set by ISO/TS 21547, Health informatics — Security requirements for archiving of electronic health records — Principles.
Health informatics — Use of mobile wireless communication and computing technology in healthcare facilities — Recommendations for electromagnetic compatibility (management of unintentional electromagnetic interference) with medical devices
Category
Technical Report
Organisation
ISO
ID
ISO/TR 21730:2007
Type
Standard
Version
2
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Status
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Created
February 2007
This document provides guidance for the deployment, use and management of mobile wireless communication and computing equipment in healthcare facilities to mitigate electromagnetic interference (EMI) hazards.
Health informatics — Personal health data generated on a daily basis
Category
Technical Report
Organisation
ISO
ID
ISO/TR 21835:2020
Type
Standard
Version
1
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Status
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Created
June 2020
This document provides an environmental scan of common health-related data elements that are combined with electronic health records (EHRs), patient portals and personal health record (PHR) systems. These data elements are captured in various ways, such as mobile and smart phones, and remote monitoring devices.
Health informatics — Guidance on the identification and authentication of connectable Personal Healthcare Devices (PHDs)
Category
Technical Report
Organisation
ISO
ID
ISO/TR 22696:2020
Type
Standard
Version
1
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Status
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Created
May 2020
This document gives guidance for managing healthcare-service security using connectable personal health devices (PHDs).
Health informatics — A case study on establishing standardized measurement data in cardiac examination reports
Category
Technical Report
Organisation
ISO
ID
ISO/TR 23358:2022
Type
Standard
Version
1
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Status
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Created
November 2022
This document reposts a case study on how to establish and maintain standardised Cardiac examination – export measurement data (CE-EMD).
Health informatics — Datasets and data structure for clinical and biological evaluation metrics in radiotherapy
Category
Technical Report
Organisation
ISO
ID
ISO/TR 24290:2023
Type
Standard
Version
1
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Status
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Created
May 2023
This document reports on the datasets and a data structure for reporting clinical and biological evaluation metrics (CBEMs) in relation to radiotherapy.
Health informatics — Applications of machine learning technologies in imaging and other medical applications
Category
Technical Report
Organisation
ISO
ID
ISO/TR 24291:2021
Type
Standard
Version
1
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Status
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Created
March 2021
This document lists examples of and defines categories of use cases for machine learning in medicine for clinical practice. It also defines the clinical usages and necessities of the artificial intelligence in medicine.
Health informatics — IHE global standards adoption – Part 1: Process
Category
Technical Report
Organisation
ISO
ID
ISO/TR 28380-1:2014
Type
Standard
Version
1
Access
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Status
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Created
February 2014
This document describes how the IHE process specifies and facilitates profiles of selected standards to support carefully defined healthcare tasks that depend on electronic information exchange.
Health informatics — IHE global standards adoption – Part 2: Integration and content profiles
Category
Technical Report
Organisation
ISO
ID
ISO/TR 28380-2:2014
Type
Standard
Version
1
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Status
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Created
February 2014
This document describes the most recent profiles developed by the Integrating the Healthcare Enterprise (IHE) initiative.
Health informatics — IHE global standards adoption – Part 3: Deployment
Category
Technical Report
Organisation
ISO
ID
ISO/TR 28380-3:2014
Type
Standard
Version
1
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Status
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Created
December 2014
This document aims to structure and facilitate adoption and deployment of health interoperability standards in a broad range of eHealth projects, including regional and national programs.
Health informatics — Introduction to Ayurveda informatics
Category
Technical Report
Organisation
ISO
ID
ISO/TR 4421:2023
Type
Standard
Version
1
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Status
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Created
June 2023
This document seeks to establish a baseline understanding of the Ayurvedic medicine system to support standardisation across countries and healthcare organisations.
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
Category
Technical Report
Organisation
ISO
ID
ISO/TR 80001-2-6:2014
Type
Standard
Version
1
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Status
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Created
December 2014
This report provides guidance on implementing responsibility agreements, which are described in IEC 80001-1 as used to establish the roles and responsibilities among the stakeholders engaged in the incorporation of a medical device into an IT network in order to support compliance with IEC 80001-1.
Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
Category
Technical Report
Organisation
ISO
ID
ISO/TR 80001-2-7:2015
Type
Standard
Version
1
Access
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Status
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Created
April 2015
The purpose of this report is to provide guidance to healthcare delivery organisations on self-assessment of their conformance against IEC 80001‑1.
Health informatics — Sex and gender in electronic health records
Category
Technical Report
Organisation
ISO
ID
ISO/TR 9143:2023
Type
Standard
Version
1
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Status
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Created
December 2023
This specification’s purpose is to describe challenges with documenting and sharing sex and gender information in electronic health records (EHRs); identify the state of international standards and specifications that include sex and gender; and summarise findings and identify opportunities to improve clarity and consistency in use of sex and gender in EHRs.
Health informatics — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis
Category
Specification
Organisation
ISO
ID
ISO/TS 11633-1:2019
Type
Standard
Version
1
Access
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Status
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Created
August 2019
This specification focuses on remote maintenance services (RMSs) for information systems in healthcare facilities as provided by vendors of medical devices and health information systems.
Health informatics — Sharing of OID registry information
Category
Specification
Organisation
ISO
ID
ISO/TS 13582:2015
Type
Standard
Version
2
Access
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Status
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Created
December 2015
This specification specifies the mandatory and optional information to be recorded in any registry of object identifiers (OIDs), using an information model. It specifies which parts of that information are to be regarded as public and which parts are to be subject to security and privacy requirements.
Health informatics — Security and privacy requirements of EHR systems for use in conformity assessment
Category
Specification
Organisation
ISO
ID
ISO/TS 14441:2013
Type
Standard
Version
1
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Created
December 2013
This specification examines electronic patient record systems at the clinical point of care that are also interoperable with electronic health records (EHRs).
Health informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine
Category
Specification
Organisation
ISO
ID
ISO/TS 16277-1:2015
Type
Standard
Version
1
Access
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Created
May 2015
This specification defines a categorial structure for clinical findings in terminological systems for traditional Chinese medicine, traditional Japanese medicine and traditional Korean medicine.
Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
Category
Specification
Organisation
ISO
ID
ISO/TS 16791:2020
Type
Standard
Version
2
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Status
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Created
September 2020
This specification provides guidelines on identification and labelling of medicinal products from the point of manufacture of packaged medicinal product to the point of dispensing the product.
Health informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points
Category
Specification
Organisation
ISO
ID
ISO/TS 16843-1:2016
Type
Standard
Version
1
Access
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Status
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Created
November 2016
This specification specifies the categorial structure in the subject field of acupuncture by defining a set of domain constraints of sanctioned characteristics each composed of a semantic link and an applicable characterising category in order to represent the concept of acupuncture point.
Health informatics — Categorial structures for representation of acupuncture — Part 2: Needling
Category
Specification
Organisation
ISO
ID
ISO/TS 16843-2:2015
Type
Standard
Version
1
Access
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Status
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Created
December 2015
The purpose of this specification is to specify categorial structures in the subject field of acupuncture by defining a set of domain constraints for use in terminological resources.
Health informatics — Categorial structures for representation of acupuncture — Part 3: Moxibustion
Category
Specification
Organisation
ISO
ID
ISO/TS 16843-3:2017
Type
Standard
Version
1
Access
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Status
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Created
December 2017
This specification aims to specify categorial structure in the field of moxibustion by defining a set of domain constraints for use in terminological resources.