International Organization for Standardization (ISO)

Acronym
ISO
Type
Standards Development Organisation

International Organisation for Standardization (ISO) is an independent, non-governmental international organisation with a membership of 169 national standards bodies. Through its members, ISO brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges. Other Standards development organisations often also participate directly in the work undertaken within ISO.  

A defined structure and process defines how ISO develop and maintain their standards. The work on the standards themselves are carried out within technical committees. These global committees have local committees that help ensure collaborative input from local communities into the global work wherever possible. For example the ISO Technical Committee for Health Informatics is TC-215, its local Standards Australia committee is IT-014.  

Australian healthcare providers use and certify to many ISO standards.  

Find out about ISO.

Find out more about how ISO is structured and governed.

Resources

Application of risk management for IT-networks incorporating medical devices – Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software

Category
Standard
Organisation
ISO
ID
IEC 80001-1:2021
Type
Standard
Version
2
Access
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Status
Active
Created
Sep 2021
This document specifies general requirements for organisations in the application of risk management before, during and after the connection of a health IT system within a health IT infrastructure.

Application of risk management for IT-networks incorporating medical devices – Part 2-1: Step by Step Risk Management of Medical IT-Networks; Practical Applications and Examples

Category
Technical Report
Organisation
ISO
ID
IEC/TR 80001-2-1:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Jul 2012
This technical report is a step-by-step guide for the application of practical risk management when creating or changing a medical IT network. It is intended for use in conjunction with the IEC 80001-1 risk management standard.

Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls

Category
Technical Report
Organisation
ISO
ID
IEC/TR 80001-2-2:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Jul 2012
This technical report creates a framework for the disclosure of security-related capabilities and risks necessary for managing risk when connecting medical devices to IT networks. It also supports the security dialogue surrounding IEC 80001-1 and informs the responsibility agreements specified in that standard.

Application of risk management for IT-networks incorporating medical devices – Part 2-4: General implementation guidance for Healthcare Delivery Organizations

Category
Technical Report
Organisation
ISO
ID
IEC/TR 80001-2-4:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Nov 2012
This technical report helps healthcare delivery organisations assess the impact of IEC 80001-1 on the organisation and establish a series of business-as-usual processes to manage risk in the creation, maintenance and upkeep of medical IT networks.

Application of risk management for IT-networks incorporating medical devices – Part 2-5: Application guidance – Guidance for distributed alarm systems

Category
Technical Report
Organisation
ISO
ID
IEC/TR 80001-2-5:2014
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 2014
This technical report provides guidance for responsible organisations, medical device manufacturers and providers of other information technology in the application of IEC 80001-1:2010 for the risk management of distributed alarm systems.

Application of risk management for IT-networks incorporating medical devices – Part 2-8: Application guidance – Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2

Category
Technical Report
Organisation
ISO
ID
IEC/TR 80001-2-8:2016
Type
Standard
Version
1
Access
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Status
Active
Created
May 2016
This technical report provides guidance to health delivery organisations and medical device manufacturers on the application of the framework outlined in IEC/TR 80001-2-2 for the communication of medical device security needs, risks and controls.

Application of risk management for IT-networks incorporating medical devices – Part 2-9: Application guidance – Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities

Category
Technical Report
Organisation
ISO
ID
IEC/TR 80001-2-9:2017
Type
Standard
Version
1
Access
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Status
Active
Created
Jan 2017
This technical report establishes a security case framework and provides guidance to healthcare delivery organisations and medical device manufacturers for identifying, developing, interpreting, updating and maintaining security cases for networked medical devices.

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
Active
Created
Apr 2015
The purpose of this report is to provide guidance to healthcare delivery organisations on self-assessment of their conformance against IEC 80001‑1.

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
Access
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Status
Active
Created
Dec 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.

Genomics informatics — Omics Markup Language (OML)

Category
Standard
Organisation
ISO
ID
ISO 21393:2021
Type
Standard
Version
1
Access
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Status
Active
Created
Jul 2021
This document applies to the data exchange format that is designed to facilitate exchanging omics data around the world without forcing changes of any database schema. It specifies the characteristics of OML from 4 perspectives: informatics, molecular, application and biological species.

Genomics informatics — Phenopackets: A format for phenotypic data exchange

Category
Standard
Organisation
ISO
ID
ISO 4454:2022
Type
Standard
Version
1
Access
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Status
Active
Created
Jul 2022
This standard specifies a uniform, machine-readable, phenotypic description of an individual, patient or sample in the context of rare disease, common/complex disease or cancer.

Health informatics - Automatic identification and data capture marking and labelling

Category
Standard
Organisation
ISO
ID
ISO 18530:2021
Type
Standard
Version
1
Access
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Status
Active
Created
2021
Updated
2023
This document outlines the standards needed to identify and label the Subject of Care (SoC) and the Individual Provider on objects such as identification tags or wrist bands, to enable automatic data capture using data carriers when delivering care.

Health informatics – Digital imaging and communication in medicine (DICOM) including workflow and data management

Category
Standard
Organisation
ISO
ID
ISO 12052:2017
Type
Standard
Version
2
Access
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Status
Active
Created
Aug 2017
This standard facilitates the production, management and exchange of digital medical images and information by specifying protocols, command syntax and semantics, media storage services for devices and a file format and medical directory structure for interchange media.

Health informatics – Electronic health record communication – Part 4: Security

Category
Standard
Organisation
ISO
ID
ISO 13606-4:2019
Type
Standard
Version
1
Access
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Status
Active
Created
Jun 2019
This document is Part 4 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 4 describes a methodology for specifying the privileges necessary to access EHR data.

Health informatics – Electronic health record communication – Part 5: Interface specification

Category
Standard
Organisation
ISO
ID
ISO 13606-5:2019
Type
Standard
Version
2
Access
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Status
Active
Created
Jun 2019
This document is Part 5 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 5 specifies the information architecture required for interoperable communications between systems and services that need or provide EHR data.

Health informatics – Electronic health record communication –Part 2: Archetype interchange specification

Category
Standard
Organisation
ISO
ID
ISO 13606-2:2019
Type
Standard
Version
2
Access
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Status
Active
Created
Jun 2019
This document is Part 2 of a 5-part series that sets out a means for communicating about electronic health records (EHRs). Part 2 defines the Archetype Model to be used to represent Archetypes when communicating between repositories and archetype services.

Health informatics – HL7 Electronic Health Record-System Functional Model

Category
Standard
Organisation
ISO
ID
ISO 10781:2023
Type
Standard
Version
2.1
Access
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Status
Active
Created
Nov 2023
This document describes the EHR-S Functional Model (EHR-S FM), which sets out standardised functional profiles for different healthcare settings (e.g. intensive care, cardiology, office practice in one country or primary care in another country).

Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

Category
Standard
Organisation
ISO
ID
ISO 11239:2023
Type
Standard
Version
2
Access
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Status
Active
Created
Jun 2023
This standard specifies the data elements, structures and relationships required for the exchange of identifying information for pharmaceutical dose forms, units of presentation, routes of administration and packaging items (containers, closures and administration devices) related to medicinal products.

Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on substances

Category
Standard
Organisation
ISO
ID
ISO 11238:2018
Type
Standard
Version
2
Access
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Status
Active
Created
Jul 2018
This document provides an information model that enables the definition and identification of substances within medicinal products or substances used for medicinal purposes, including dietary supplements, foods and cosmetics.

Health informatics – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information – Amendment 1

Category
Standard
Organisation
ISO
ID
ISO 11615:2017/Amd 1:2022
Type
Standard
Version
2
Access
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Status
Active
Created
Aug 2022
This document adds an additional annex to ISO 11615:2017. The annex specifies class name and attribute translations and synonyms for the identification of medicinal products.

Health informatics – Information models – Biomedical Research Integrated Domain Group (BRIDG) Model

Category
Standard
Organisation
ISO
ID
ISO 14199:2015
Type
Standard
Version
1
Access
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Status
Active
Created
Sep 2015
This document defines a set of models collectively referred to as the Biomedical Research Integrated Domain Group (BRIDG) model. This model enables semantic interoperability within the biomedical and clinical research domain and between the research and healthcare domains.

Health informatics – Syntax to represent the content of healthcare classification systems – Classification Markup Language (ClaML)

Category
Standard
Organisation
ISO
ID
ISO 13120:2019
Type
Standard
Version
2
Access
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Status
Active
Created
Apr 2019
This document describes Classification Markup Language (ClaML), which formally represents the content and hierarchical structure of healthcare classification systems for the safe exchange and distribution of data and structure between organisations and dissimilar software products.

Health informatics — Audit trails for electronic health records

Category
Standard
Organisation
ISO
ID
ISO 27789:2021
Type
Standard
Version
2
Access
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Status
Active
Created
Oct 2021
This standard specifies a common framework for audit trails for electronic health records, in terms of audit trigger events and audit data, to keep the complete set of personal health information auditable across information systems and domains.

Health informatics — Business requirements for a syntax to exchange structured dose information for medicinal products

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 17251:2023
Type
Standard
Version
2
Access
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Status
Active
Created
Feb 2023
This specification specifies the business requirements for the structured content of structured or semi-structured dose instructions for recording dose instructions in the electronic health record, supporting clinical decision support, and exchanging medication orders, as applicable to primary, secondary and tertiary care.

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
Access
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Status
Active
Created
Oct 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 — Categorial structure for representation of herbal medicaments in terminological systems

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 18062:2016
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 2016
This specification aims to (a) specify the minimal characterising generic concepts for herbal medicaments in terminological systems, which are needed for terms used to identify herbal medicines regulated by medicine regulatory agencies, and (b) facilitate consistency and interoperability of the terms and their designating concepts in terminological systems.

Health informatics — Categorial structure for terminological systems of surgical procedures

Category
Standard
Organisation
ISO
ID
ISO 1828:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Sep 2012
This standard specifies the minimal characteristics of a categorial structure for terminological systems of surgical procedures. It also specifies the minimal domain constraints to support interoperability, comparability and the exchange of meaningful information on surgical procedures.

Health informatics — Categorial structures for representation of acupuncture — Part 1: Acupuncture points

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 16843-1:2016
Type
Standard
Version
1
Access
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Status
Active
Created
Nov 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 4: Meridian and collateral channels

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 16843-4:2017
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 2017
This specification specifies the categorial structure in the subject field of meridian and collateral 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 meridian and collateral.

Health informatics — Categorial structures for representation of acupuncture — Part 6: Acupuncture effects

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 16843-6:2022
Type
Standard
Version
1
Access
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Status
Active
Created
Jun 2022
This specification specifies the categorial structure in the field of acupuncture effects by defining a set of domain constraints of sanctioned characteristics, each consisting of a semantic link and an applicable characterising category.

Health informatics — Categorial structures for representation of nursing practice in terminological systems

Category
Standard
Organisation
ISO
ID
ISO 18104:2023
Type
Standard
Version
3
Access
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Status
Active
Created
Dec 2023
This standard specifies the characteristics of categorial structures representing nursing practice. The overall aim of this standard is to support interoperability in the exchange of meaningful information between information systems in respect of nursing diagnoses, nursing actions and nurse sensitive outcomes.

Health informatics — Categorial structures of clinical findings in traditional medicine — Part 1: Traditional Chinese, Japanese and Korean medicine

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 16277-1:2015
Type
Standard
Version
1
Access
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Status
Active
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 — Clinical document registry federation

Category
Technical Report
Organisation
ISO
ID
ISO/TR 13128:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Jul 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 — Clinical stakeholder participation in the work of ISO TC 215

Category
Technical Report
Organisation
ISO
ID
ISO/TR 11487:2008
Type
Standard
Version
1
Access
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Status
Withdrawn
Created
Dec 2008
This report clarifies and confirms TC 215 support for clinical stakeholder participation. It also makes recommendations to the TC and national member organisations on approaches to improving clinical stakeholder participation, based on examples of existing effective participation models.

Health informatics — Common terminology services

Category
Standard
Organisation
ISO
ID
ISO/HL7 27951:2009
Type
Standard
Version
1
Access
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Status
Active
Created
2009
Updated
2020
This standard seeks to establish an international framework for the development of an application programming interface (API) that can be used by messaging software when accessing terminological content.

Health informatics — Device interoperability – Part 20701: Point-of-care medical device communication — Service oriented medical device exchange architecture and protocol binding

Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-20701:2020
Type
Standard
Version
1
Access
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Status
Active
Created
Mar 2020
This standard provides a service-oriented medical device architecture and communication protocol specification. It applies to point-of-care (PoC) medical devices and medical IT systems in a distributed system that need to exchange data or safely control networked PoC medical devices

Health informatics — Electronic health record — Definition, scope and context

Category
Technical Report
Organisation
ISO
ID
ISO/TR 20514:2005
Type
Standard
Version
1
Access
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Status
Active
Created
Oct 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 — Framework for healthcare and related data reporting

Category
Standard
Organisation
ISO
ID
ISO 29585:2023
Type
Standard
Version
1
Access
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Status
Active
Created
Jun 2023
This standard deals with the reporting of data to support improved public health, more effective health care and better health outcomes. It provides guidance and requirements for those developing or deploying a healthcare data reporting service, addressing data capture, processing, aggregation and data modelling, and architecture and technology approaches.

Health informatics — Functional and structural roles

Category
Standard
Organisation
ISO
ID
ISO 21298:2017
Type
Standard
Version
1
Access
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Status
Active
Created
Feb 2017
This standard defines a model for expressing functional and structural roles for health professionals and consumers and populates the model with a basic set of roles for international use in health applications.

Health informatics — Genomic Sequence Variation Markup Language (GSVML)

Category
Standard
Organisation
ISO
ID
ISO 25720:2009
Type
Standard
Version
1
Access
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Status
Active
Created
Aug 2009
This standard applies to the data exchange format that is designed to facilitate the exchange of the genomic sequence variation data around the world, without forcing change of any database schema.

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
Access
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Status
Active
Created
Dec 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 — Guidelines for terminology development organizations

Category
Technical Report
Organisation
ISO
ID
ISO/TR 12309:2009
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 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 — Health cards — General characteristics

Category
Standard
Organisation
ISO
ID
ISO 20301:2014
Type
Standard
Version
2
Access
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Status
Active
Created
Jan 2014
This standard describes general characteristics of machine-readable cards used in the field of healthcare. It focuses on cards of ID-1 type that are issued for healthcare services that crosses the borders of two or more countries or areas.

Health informatics — Health indicators conceptual framework

Category
Standard
Organisation
ISO
ID
ISO 21667:2010
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 2010
This standard establishes a common health indicators conceptual framework, and aims to foster a common vocabulary and conceptual definitions for the framework. The framework defines the appropriate dimensions and sub-dimensions required to describe the health of the population and performance of a healthcare system.

Health informatics — Health informatics profiling framework

Category
Technical Report
Organisation
ISO
ID
ISO/TR 17119:2005
Type
Standard
Version
1
Access
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Status
Active
Created
Jan 2005
This document provides a common description framework for health informatics standards artefacts – the health informatics profiling framework (HIPF).

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
Active
Created
Feb 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 3: Deployment

Category
Technical Report
Organisation
ISO
ID
ISO/TR 28380-3:2014
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 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 — Individual case safety reports (ICSRs) in pharmacovigilance – Part 1: Framework for adverse event reporting

Category
Standard
Organisation
ISO
ID
ISO/HL7 27953-1:2011
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 2011
Updated
Oct 2012
This standard provides a common messaging format for transmitting individual case safety reports for adverse drug reactions, adverse events, product problems and consumer complaints that can occur upon the administration or use of one or more products.

Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance – Part 2: Human pharmaceutical reporting requirements for ICSR

Category
Standard
Organisation
ISO
ID
ISO/HL7 27953-2:2011
Type
Standard
Version
1
Access
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Status
Active
Created
Dec 2011
Updated
Oct 2012
This standard provides a common set of data elements and a messaging format for transmitting individual case safety reports for adverse drug reactions, adverse events, infections, and incidents that can occur from the administration of one or more human pharmaceutical products to a patient, regardless of source and destination

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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Status
Active
Created
Feb 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 — Information security management for remote maintenance of medical devices and medical information systems — Part 1: Requirements and risk analysis

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 11633-1:2019
Type
Standard
Version
1
Access
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Status
Active
Created
Aug 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 — Introduction to Ayurveda informatics

Category
Technical Report
Organisation
ISO
ID
ISO/TR 4421:2023
Type
Standard
Version
1
Access
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Status
Active
Created
Jun 2023
This document seeks to establish a baseline understanding of the Ayurvedic medicine system to support standardisation across countries and healthcare organisations.

Health informatics — Medical waveform format — Part 1: Encoding rules

Category
Standard
Organisation
ISO
ID
ISO 22077-1:2022
Type
Standard
Version
2
Access
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Status
Active
Created
Jan 2022
This standard specifies how medical waveforms, such as electrocardiogram, electroencephalogram, spirometry waveform and so on, are described for interoperability among healthcare information systems.

Health informatics — Medical waveform format — Part 2: Electrocardiography

Category
Standard
Organisation
ISO
ID
ISO 22077-2:2023
Type
Standard
Version
1
Access
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Status
Active
Created
Aug 2023
This standard defines the application of medical waveform format encoding rules (MFER) to describe standard electrocardiography waveforms measured in physiological laboratories, hospital wards, clinics and primary care medical check-ups.

Health informatics — Medication management concepts and definitions

Category
Technical Report
Organisation
ISO
ID
ISO/TR 20831:2017
Type
Standard
Version
1
Access
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Status
Active
Created
Jul 2017
This document defines the various concepts and terminologies used in the pharmacy domain relating to creating medication lists from existing data.

Health informatics — Patient healthcard data – Part 2: Common objects

Category
Standard
Organisation
ISO
ID
ISO 21549-2:2014
Type
Standard
Version
2
Access
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Status
Active
Created
Feb 2014
This standard describes and defines the Common Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).

Health informatics — Patient healthcard data – Part 3: Limited clinical data

Category
Standard
Organisation
ISO
ID
ISO 21549-3:2014
Type
Standard
Version
2
Access
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Status
Active
Created
Feb 2014
This standard describes and defines the Limited Clinical Data objects used within, or referenced by, patient-held health data cards using UML, plain text and Abstract Syntax Notation (ASN.1).

Health informatics — Patient healthcard data – Part 8: Links

Category
Standard
Organisation
ISO
ID
ISO 21549-8:2010
Type
Standard
Version
1
Access
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Status
Active
Created
Jun 2010
This standard defines a way to facilitate access to distributed patient records and/or administrative information using healthcards.

Health informatics — Personal health data generated on a daily basis

Category
Technical Report
Organisation
ISO
ID
ISO/TR 21835:2020
Type
Standard
Version
1
Access
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Status
Active
Created
Jun 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 — Personal health device communication – Part 10418: Device specialization — International Normalized Ratio (INR) monitor

Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10418:2014
Type
Standard
Version
1
Access
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Status
Active
Created
Mar 2014
This standard establishes a normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers in a way that enables plug-and-play interoperability.

Health informatics — Personal health device communication – Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE)

Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10424:2016
Type
Standard
Version
1
Access
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Status
Active
Created
Jun 2016
This standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment (SABTE) devices and managers, in a way that enables plug-and-play interoperability.

Health informatics — Personal health device communication – Part 10441: Device specialization — Cardiovascular fitness and activity monitor

Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10441:2015
Type
Standard
Version
1
Access
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Status
Active
Created
Mar 2015
This standard establishes a normative definition of communication between personal telehealth cardiovascular fitness and activity monitor devices and managers in a way that enables plug-and-play interoperability.

Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor – Technical Corrigendum 1

Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10418:2014/Cor 1:2016
Type
Standard
Version
1
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Created
Oct 2016
This corrigendum contains corrected errors and that apply to ISO/IEEE 11073-10418:2014 Health informatics — Personal health device communication – Part 10418: Device specialization — International Normalized Ratio (INR) monitor.

Health informatics — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) – Technical Corrigendum 1

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Standard
Organisation
ISO
ID
ISO/IEEE 11073-10424:2016/Cor 1:2018
Type
Standard
Version
1
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This corrigendum contains corrected errors that apply to ISO/IEEE 11073-10424:2016 Health informatics — Personal health device communication – Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE).

Health informatics — Point-of-care medical device communication – Part 20702: Medical devices communication profile for web services

Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-20702:2018
Type
Standard
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Created
Sep 2018
This standard defines a communication protocol specification for a distributed system of point-of-care (PoC) medical devices and medical IT systems that need to exchange data, or safely control networked PoC medical devices by profiling web service specifications.

Health informatics — Principles and data requirements for consent in the collection, use or disclosure of personal health information

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 17975:2022
Type
Standard
Version
2
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Created
Nov 2022
This specification defines the set of frameworks of consent for the collection, use and/or disclosure of personal information by healthcare practitioners or organisations that are frequently used to obtain agreement to process the personal health information of subjects of care.

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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Created
Nov 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 — Privilege management and access control — Part 1: Overview and policy management

Category
Standard
Organisation
ISO
ID
ISO 22600-1:2014
Type
Standard
Version
1
Access
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Status
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Created
Oct 2014
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-1:2014 proposes a template for the policy agreement. It enables the comparable documentation from all parties involved in the information exchange.

Health informatics — Privilege management and access control — Part 2: Formal models

Category
Standard
Organisation
ISO
ID
ISO 22600-2:2014
Type
Standard
Version
1
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Created
Oct 2014
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-2:2014 introduces the underlying paradigm of formal high-level models for architectural components.

Health informatics — Privilege management and access control — Part 3: Implementations

Category
Standard
Organisation
ISO
ID
ISO 22600-3:2014
Type
Standard
Version
1
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Created
Oct 2014
ISO 22600 defines principles and specifies services needed for managing privileges and access control to data and/or functions. ISO 22600-3:2014 instantiates requirements for repositories for access control policies and requirements for privilege management infrastructures.

Health informatics — Profiling framework and classification for Traditional Medicine informatics standards development — Part 1: Traditional Chinese Medicine

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 18790-1:2015
Type
Standard
Version
1
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Created
May 2015
This specification establishes common concepts and a vocabulary for describing the complex domain of various traditional Chinese medicine informatics standards initiatives and their supporting artefacts.

Health informatics — Public key infrastructure — Part 2: Certificate profile

Category
Standard
Organisation
ISO
ID
ISO 17090-2:2015
Type
Standard
Version
2
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Created
Nov 2015
This standard specifies the certificate profiles required to interchange health care information within a single organisation, between different organisations and across jurisdictional boundaries. It details the use made of digital certificates in the health industry and focuses, in particular, on specific healthcare issues relating to certificate profiles.

Health informatics — Public key infrastructure — Part 3: Policy management of certification authority

Category
Standard
Organisation
ISO
ID
ISO 17090-3:2021
Type
Standard
Version
2
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Created
Mar 2021
This standard gives guidelines for certificate management issues involved in deploying digital certificates in health care. It specifies a structure and minimum requirements for certificate policies, as well as a structure for associated certification practice statements.

Health informatics — Quality metrics for detailed clinical models

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 18864:2017
Type
Standard
Version
1
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Status
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Created
Nov 2017
The purpose of this specification is to define objective, reliable and reproducible quality metrics for detailed clinical models.

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
Oct 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 — Sex and gender in electronic health records

Category
Technical Report
Organisation
ISO
ID
ISO/TR 9143:2023
Type
Standard
Version
1
Access
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Status
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Created
Dec 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 — Sharing of OID registry information

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 13582:2015
Type
Standard
Version
2
Access
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Status
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Created
Dec 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 — Standard communication protocol — Computer-assisted electrocardiography

Category
Standard
Organisation
ISO
ID
ISO 41064:2023
Type
Standard
Version
1
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Status
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Created
Jun 2023
This standard specifies the common conventions needed for the interchange of specific patient data (such as on demographics and recording conditions), electrocardiogram (ECG) signal data and metadata, ECG measurements and ECG annotations, and ECG interpretation results.

Health informatics — Traditional Chinese medicine literature metadata

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 17948:2014
Type
Standard
Version
1
Access
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Status
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Created
Jul 2014
This specification defines a core set of traditional Chinese medicine (TCM) literature metadata, describes the principles and methods of TCM metadata, and specifies the formal description of TCM metadata.

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
Access
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Status
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Created
Feb 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 software – Part 1: General requirements for product safety

Category
Standard
Organisation
ISO
ID
IEC 82304-1:2016
Type
Standard
Version
1
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Status
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Created
Oct 2016
This document sets out the safety and security requirements for manufacturers of health software products that are designed to operate on general computing platforms without dedicated hardware.

Healthcare organization management — Hand hygiene performance

Category
Standard
Organisation
ISO
ID
ISO 23447:2023
Type
Standard
Version
1
Access
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Status
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Created
Oct 2023
This standard specifies hand hygiene training, compliance benchmarking, performance/feedback, and facility requirements for healthcare facilities that operate hand hygiene systems.

Healthcare organization management — Infection prevention and control (IPC) measures for cross-border workers

Category
Technical Specification
Organisation
ISO
ID
ISO/TS 17371:2023
Type
Standard
Version
1
Access
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Status
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Created
Dec 2023
This specification specifies infection prevention and control measures for cross-border workers. It applies during a novel infectious disease outbreak when valid vaccines or drugs for treatment are not available. It can be used to maintain economic activities when a country that workers need to enter blocks its border due to a pandemic or epidemic.

Healthcare organization management — Vocabulary

Category
Standard
Organisation
ISO
ID
ISO 22886:2020
Type
Standard
Version
1
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Status
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Created
Aug 2020
This standard defines terms used in healthcare organisation management.

Knowledge management of health information standards

Category
Technical Report
Organisation
ISO
ID
ISO/TR 13054:2012
Type
Standard
Version
1
Access
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Status
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Created
Aug 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.

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