Search for standards based on keywords, categories, and organisations. You can also search more broadly for other resources or all content.
Health informatics โ Interoperability of public health emergency preparedness and response information systems
Category
Standard
Organisation
ISO
ID
ISO 5477:2023
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
2023
This standard provides business rules for public health emergency preparedness and response (PH EPR) information systems.
Healthcare organization management โ Pandemic response โ Temporary medical facility
Category
Standard
Organisation
ISO
ID
ISO 5741:2023
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
2023
This standard focuses on the operation of temporary isolation and quarantine facilities.
Healthcare organization management โ Pandemic response โ Functional requirements for self-symptom checker app
Category
Standard
Organisation
ISO
ID
ISO 6028:2023
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
2023
This standard specifies the functional requirements for a self-initiated disease symptom checker app to be used for early screening and control of pandemics such as COVID-19.
Healthcare organization management โ Management systems for quality in healthcare organizations โ Requirements
Category
Standard
Organisation
ISO
ID
ISO 7101:2023
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
2023
This standard provide organisations with requirements to deliver high-quality healthcare. It helps organisations navigate the complexities of healthcare, such as limited resources, ageing populations, and global pandemics.
Health informatics โ HL7 version 3 โ Reference information model โ Release 4
Category
Standard
Organisation
ISO
ID
ISO/HL7 21731:2014
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
2014
Updated
2020
The Health Level Seven (HL7) Reference Information Model (RIM) is a static model of health and healthcare information in the context of developing HL7 standards.
Data Exchange Standards โ Health Level Seven Version 2.5 โ An application protocol for electronic data exchange in healthcare environments
Category
Standard
Organisation
ISO
ID
ISO/HL7 27931:2009
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
2009
Updated
2023
This standard sets an application protocol for the electronic exchange of data in healthcare environments.
Data Exchange Standards โ HL7 Clinical Document Architecture
Category
Standard
Organisation
ISO
ID
ISO/HL7 27932:2009
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
2009
Updated
2020
This standard specifies the structure and semantics of a clinical document for exchange.
Health informatics โ Common terminology services
Category
Standard
Organisation
ISO
ID
ISO/HL7 27951:2009
Type
Standard
Version
1
Access
Fees apply to access
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 โ Individual case safety reports (ICSRs) in pharmacovigilance โ Part 1: Framework for adverse event reporting
Category
Standard
Organisation
ISO
ID
ISO/HL7 27953-1:2011
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
December 2011
Updated
October 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 โ Individual case safety reports (ICSRs) in pharmacovigilance โ Part 2: Human pharmaceutical reporting requirements for ICSR
Category
Standard
Organisation
ISO
ID
ISO/HL7 27953-2:2011
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
December 2011
Updated
October 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 โ Personal health device communication โ Part 00103: Overview
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-00103:2015
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
March 2015
Health informatics โ Device interoperability โ Part 10101: Point-of-care medical device communication โ Nomenclature
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10101:2020
Type
Standard
Version
2
Access
Fees apply to access
Status
Active
Created
August 2020
This standard defines a nomenclature for communicating information from point-of-care medical devices, with a focus on acute-care medical devices and patient vital signs information.
Health informatics โ Point-of-care medical device communication โ Part 10102: Nomenclature โ Annotated ECG
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10102:2014
Type
Standard
Version
1
Access
Fees apply to access
Status
Active
Created
March 2014
This standard extends IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology.
Health informatics โ Point-of-care medical device communication โ Part 10103: Nomenclature โ Implantable device, cardiac
Category
Standard
Organisation
ISO
ID
ISO/IEEE 11073-10103:2014
Type
Standard
Access
Fees apply to access
Status
Active
Created
March 2014
This standard extends IEEE 11073 to support terminology for implantable cardiac devices.
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
Fees apply to access
Status
Active
Created
May 2020
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
Fees apply to access
Status
Active
Created
March 2019
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
Fees apply to access
Status
Active
Created
May 2020
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
Fees apply to access
Status
Active
Created
December 2012
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
Fees apply to access
Status
Active
Created
December 2022
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
Fees apply to access
Status
Active
Created
December 2022
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
Fees apply to access
Status
Active
Created
December 2022
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
Fees apply to access
Status
Active
Created
April 2017
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
Fees apply to access
Status
Active
Created
March 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 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
Fees apply to access
Status
Active
Created
October 2016
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
Fees apply to access
Status
Active
Created
March 2019
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
Fees apply to access
Status
Active
Created
December 2022
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
Fees apply to access
Status
Withdrawn
Created
November 2012
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
Fees apply to access
Status
Active
Created
August 2017
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
Fees apply to access
Status
Active
Created
June 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 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
Fees apply to access
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
Fees apply to access
Status
Superseded
Created
March 2019
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
Fees apply to access
Status
Active
Created
January 2018
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
Fees apply to access
Status
Active
Created
March 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 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
Fees apply to access
Status
Active
Created
March 2015
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
Fees apply to access
Status
Superseded
Created
May 2010
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
Fees apply to access
Status
Withdrawn
Created
November 2012
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
Fees apply to access
Status
Active
Created
December 2014
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
Fees apply to access
Status
Active
Created
December 2022
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
Fees apply to access
Status
Active
Created
March 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 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
Fees apply to access
Status
Active
Created
September 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 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
Fees apply to access
Status
Active
Created
December 2004
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
Fees apply to access
Status
Active
Created
March 2015
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
Fees apply to access
Status
Active
Created
November 2011
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
Fees apply to access
Status
Active
Created
March 2022
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
Fees apply to access
Status
Active
Created
March 2022
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
Fees apply to access
Status
Active
Created
January 2024
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
Fees apply to access
Status
Active
Created
June 2023
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
Fees apply to access
Status
Withdrawn
Created
December 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.