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Health informatics โ Device interoperability โ Part 10201: Point-of-care medical device communication โ Domain information model
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10201:2020
Type
Standard
Version
2
Access
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Status
Active
Created
May-20
Health informatics โ Personal health device communication โ Part 10207: Domain information and service model for service-oriented point-of-care medical device communication
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10207:2019
Type
Standard
Version
1
Access
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Status
Active
Created
Mar-19
This standard provides a Participant Model derived from the ISO/IEEE11073-10201 Domain Information Model.
Health informatics โ Device interoperability โ Part 10201: Point-of-care medical device communication โ Domain information model
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10201:2020
Type
Standard
Version
2
Access
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Status
Active
Created
May-20
This standard defines a general object-oriented information model that may be used to structure information and identify services used in point-of-care medical device communications.
Health informatics โ Personal health device communication โ Part 10406: Device specialization โ Basic electrocardiograph (ECG) (1- to 3-lead ECG)
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10406:2012
Type
Standard
Version
1
Access
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Status
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Created
Dec-12
This standard provides a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers in a way that enables plug-and-play interoperability.
Health informatics โ Device interoperability โ Part 10407: Personal health device communication โ Device specialization โ Blood pressure monitor
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10407:2022
Type
Standard
Version
2
Access
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Status
Active
Created
Dec-22
This standard establishes a normative definition of communication between personal telehealth blood pressure monitor devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics โ Device interoperability โ Part 10408: Personal health device communication โ Device specialization โ Thermometer
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10408:2022
Type
Standard
Version
2
Access
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Status
Active
Created
Dec-22
This standard establishes a normative definition of communication between personal telehealth thermometer devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics โ Device interoperability โ Part 10415: Personal health device communication โ Device specialization โ Weighing scale
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10415:2022
Type
Standard
Version
2
Access
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Status
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Created
Dec-22
This standard establishes a normative definition of communication between personal telehealth weighing scale devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10417: Device specialization โ Glucose meter
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10417:2017
Type
Standard
Version
3
Access
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Status
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Created
Apr-17
This standard establishes a normative definition of communication between personal telehealth glucose meter devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10418: Device specialization โ 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
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Created
Mar-14
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 โ Personal health device communication โ Part 10418: Device specialization โ International Normalized Ratio (INR) monitor โ Technical Corrigendum 1
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10418:2014/Cor 1:2016
Type
Standard
Version
1
Access
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Status
Active
Created
Oct-16
This corrigendum contains corrected errors and that apply to ISO/IEEE 11073-10418:2014 Health informatics โ Personal health device communication โ Part 10418: Device specialization โ International Normalized Ratio (INR) monitor.
Health informatics โ Personal health device communication โ Part 10419: Device specialization โ Insulin pump
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10419:2019
Type
Standard
Version
2
Access
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Status
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Created
Mar-19
This standard establishes a normative definition of communication between personal telehealth insulin pump devices and managers in a way that enables plug-and-play interoperability.
Health informatics โ Device interoperability โ Part 10420: Personal health device communication โ Device specialization โ Body composition analyzer
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10420:2022
Type
Standard
Version
2
Access
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Status
Active
Created
Dec-22
This standard establishes a normative definition of the communication between personal body composition analyser agents and managers in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10421: Device specialization โ Peak expiratory flow monitor (peak flow)
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10421:2012
Type
Standard
Version
1
Access
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Status
Withdrawn
Created
Nov-12
This standard establishes a normative definition of communication between personal telehealth peak expiratory flow monitor devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10422: Device specialization โ Urine analyser
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10422:2017
Type
Standard
Version
1
Access
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Status
Active
Created
Aug-17
This standard establishes a normative de๏ฌnition of communication between personal telehealth urine analyser devices and managers in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10424: Device specialization โ 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-16
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 โ Personal health device communication โ Part 10424: Device specialization โ Sleep apnoea breathing therapy equipment (SABTE) โ Technical Corrigendum 1
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10424:2016/Cor 1:2018
Type
Standard
Version
1
Access
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Status
Active
This corrigendum contains corrected errors that apply to ISO/IEEE 11073-10424:2016 Health informatics โ Personal health device communication โ Part 10424: Device specialization โ Sleep apnoea breathing therapy equipment (SABTE).
Health informatics โ Personal health device communication โ Part 10425: Device specialization โ Continuous glucose monitor (CGM)
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10425:2019
Type
Standard
Version
3
Access
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Status
Superseded
Created
Mar-19
This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices and managers in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10427: Device specialization โ Power status monitor of personal health devices
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10427:2018
Type
Standard
Version
1
Access
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Status
Active
Created
Jan-18
This standard establishes a normative de๏ฌnition of communication between devices containing a power source and managers in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10441: Device specialization โ 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-15
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 โ Personal health device communication โ Part 10442: Device specialization โ Strength fitness equipment
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10442:2015
Type
Standard
Version
1
Access
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Status
Active
Created
Mar-15
This standard establishes a normative definition of the communication between personal strength fitness devices and managers in a way that enables plug-and-play interoperability.
Health informatics โ Personal health device communication โ Part 10471: Device specialization - Independent living activity hub
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10471:2010
Type
Standard
Version
1
Access
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Status
Superseded
Created
May-10
This standard establishes a normative definition of the communication between independent-living activity hubs and managers in a way that enables plug-and-play interoperability.
Health Informatics โ Personal health device communication โ Part 10472: Device specialization โ Medication monitor
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10472:2012
Type
Standard
Version
1
Access
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Status
Withdrawn
Created
Nov-12
This standard establishes a normative definition of communication between personal telehealth medication monitor devices and compute engines in a way that enables plug-and-play interoperability.
Health informatics โ Point-of-care medical device communication โ Part 20101: Application profiles โ Base standard
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-20101:2004
Type
Standard
Version
1
Access
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Status
Active
Created
Dec-14
This standard provides the upper layer services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications.
Health informatics โ Device interoperability โ Part 20601: Personal health device communication โ Application profile โ Optimized exchange protocol
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-20601:2022
Type
Standard
Version
3
Access
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Status
Active
Created
Dec-22
This standard defines modelling techniques and an optimised exchange protocol for implementers of personal health devices to create interoperability between device types and vendors.
Health informatics โ Device interoperability โ Part 20701: Point-of-care medical device communication โ 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-20
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 โ Point-of-care medical device communication โ Part 20702: Medical devices communication profile for web services
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-20702:2018
Type
Standard
Access
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Status
Active
Created
Sep-18
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 โ Point-of-care medical device communication โ Part 30200: Transport profile โ Cable connected
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-30200:2004
Type
Standard
Access
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Status
Active
Created
Dec-04
This standard describes an IrDA-based, cable-connected local area network (LAN) for the interconnection of computers and medical devices.
Health informatics โ Point-of-care medical device communication โ Part 30200: Transport profile โ Cable connected โ Amendment 1
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-30200:2004/Amd 1:2015
Type
Standard
Version
1
Access
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Status
Active
Created
Mar-15
This amendment applies to ISO/IEEE 11073-30200:2004 Health informatics โ Point-of-care medical device communication โ Part 30200: Transport profile โ Cable connected.
Health informatics โ Point-of-care medical device communication โ Part 30400: Interface profile โ Cabled Ethernet
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-30400:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Nov-11
This standard addresses the application of the Ethernet family (IEEE Std 802.3-2008) of protocols for use in medical device communication.
Health informatics โ Device interoperability โ Part 40101: Foundational โ Cybersecurity โ Processes for vulnerability assessment
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-40101:2022
Type
Standard
Version
1
Access
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Status
Active
Created
Mar-22
This standard defines an iterative, systematic, scalable, and auditable approach to identifying cyber security vulnerabilities and estimating risk for personal health devices and point-of-care devices.
Health informatics โ Device interoperability โ Part 40102: Foundational โ Cybersecurity โ Capabilities for mitigation
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-40102:2022
Type
Standard
Version
1
Access
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Status
Active
Created
Mar-22
This standard defines a security baseline of application-layer cyber security mitigation techniques personal health device and point-of-care device interfaces.
Healthcare organization management โ Pandemic response โGuidelines for respiratory infection prevention and control in hospitals
Category
Standard
Organisation
ISO
ID
ISO/PAS 18999:2024
Type
Standard
Version
1
Access
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Status
Active
Created
Jan-24
This standard provides comprehensive guidelines for pandemic response, particularly focusing on respiratory infection prevention and control in hospitals.
Health informatics โ Personalized digital health โ Digital therapeutics health software systems
Category
Technical Report
Organisation
ISO
ID
ISO/TR 11147:2023
Type
Standard
Version
1
Access
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Status
Active
Created
Jun-23
This standard lists characteristics of digital therapeutics (DTx) software which generate and deliver medical interventions.
Health informatics โ 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-08
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 โ Information security management for remote maintenance of medical devices and medical information systems โ 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-21
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 โ Dynamic on-demand virtual private network for health information infrastructure
Category
Technical Report
Organisation
ISO
ID
ISO/TR 11636:2009
Type
Standard
Version
1
Access
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Status
Active
Created
Dec-09
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 โ Principles of mapping between terminological systems
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12300:2014
Type
Standard
Version
1
Access
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Status
Active
Created
Nov-14
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 โ 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-09
This document specifies the principles and processes that should be followed by developers of healthcare terminologies to support international healthcare terminology standardisation.
Health informatics โ 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
Access
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Status
Active
Created
May-15
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 โ Part 1: Requirements
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12773-1:2009
Type
Standard
Version
1
Access
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Status
Active
Created
Jun-09
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 โ Part 2: Environmental scan
Category
Technical Report
Organisation
ISO
ID
ISO/TR 12773-2:2009
Type
Standard
Version
1
Access
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Status
Active
Created
Jun-09
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
Access
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Status
Active
Created
Aug-12
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 โ 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-12
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 โ Personal health records โ Definition, scope and context
Category
Technical Report
Organisation
ISO
ID
ISO/TR 14292:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Mar-12
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 โ Capacity-based eHealth architecture roadmap โ Part 1: Overview of national eHealth initiatives
Category
Technical Report
Organisation
ISO
ID
ISO/TR 14639-1:2012
Type
Standard
Version
1
Access
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Status
Active
Created
Aug-12
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 โ Capacity-based eHealth architecture roadmap โ 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-14
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 โ Identification of medicinal products โ Core principles for maintenance of identifiers and terms
Category
Technical Report
Organisation
ISO
ID
ISO/TR 14872:2019
Type
Standard
Version
1
Access
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Status
Active
Created
Jul-19
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 โ Interoperability of telehealth systems and networks โ Part 1: Introduction and definitions
Category
Technical Report
Organisation
ISO
ID
ISO/TR 16056-1:2004
Type
Standard
Version
1
Access
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Status
Active
Created
Jul-04
This document briefly introduces the interoperability of telehealth systems and networks, and defines telehealth and related terms.