Health informatics — 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 — Pandemic response — 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 — Pandemic response — 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 — Management systems for quality in healthcare organizations — 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 — HL7 version 3 — Reference information model — 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 — Health Level Seven Version 2.5 — 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 — 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 — 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 — 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 Fees apply to access Status Active Created Dec-11 Updated Oct-12 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 Fees apply to access Status Active Created Dec-11 Updated Oct-12 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 — Personal health device communication – 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 Mar-15
Health informatics — Device interoperability – Part 10101: Point-of-care medical device communication — Nomenclature Category Standard Organisation ISO ID ISO/IEEE 11073-10101:2020 Type Standard Version 2 Access Fees apply to access Status Active Created Aug-20 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 — Point-of-care medical device communication – Part 10102: Nomenclature — Annotated ECG Category Standard Organisation ISO ID ISO/IEEE 11073-10102:2014 Type Standard Version 1 Access Fees apply to access Status Active Created Mar-14 This standard extends IEEE 11073-10101 Nomenclature by providing support for ECG annotation terminology.
Health informatics — Point-of-care medical device communication – Part 10103: Nomenclature — Implantable device, cardiac Category Standard Organisation ISO ID ISO/IEEE 11073-10103:2014 Type Standard Access Fees apply to access Status Active Created Mar-14 This standard extends IEEE 11073 to support terminology for implantable cardiac devices.
Health informatics — Device interoperability – Part 10201: Point-of-care medical device communication — 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-20
Health informatics — Personal health device communication – 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 Mar-19 This standard provides a Participant Model derived from the ISO/IEEE11073-10201 Domain Information Model.
Health informatics — Device interoperability – Part 10201: Point-of-care medical device communication — 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-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 — Personal health device communication – Part 10406: Device specialization — 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 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 — Device interoperability – Part 10407: Personal health device communication — Device specialization — 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 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 — Device interoperability – Part 10408: Personal health device communication — Device specialization — Thermometer Category Standard Organisation ISO ID ISO/IEEE 11073-10408:2022 Type Standard Version 2 Access Fees apply to access 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 — Device interoperability – Part 10415: Personal health device communication — Device specialization — Weighing scale Category Standard Organisation ISO ID ISO/IEEE 11073-10415:2022 Type Standard Version 2 Access Fees apply to access Status Active 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 — Personal health device communication – Part 10417: Device specialization — Glucose meter Category Standard Organisation ISO ID ISO/IEEE 11073-10417:2017 Type Standard Version 3 Access Fees apply to access Status Active 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 — 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 Fees apply to access Status Active 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 — 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 Access Fees apply to access Status Active Created Oct-16 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 10419: Device specialization — Insulin pump Category Standard Organisation ISO ID ISO/IEEE 11073-10419:2019 Type Standard Version 2 Access Fees apply to access Status Active 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 — Device interoperability – Part 10420: Personal health device communication — Device specialization — 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 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 — Personal health device communication – Part 10421: Device specialization — 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 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 — Personal health device communication – Part 10422: Device specialization — Urine analyser Category Standard Organisation ISO ID ISO/IEEE 11073-10422:2017 Type Standard Version 1 Access Fees apply to access Status Active Created Aug-17 This standard establishes a normative definition of communication between personal telehealth urine analyser devices 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 Fees apply to access 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 — Personal health device communication — Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE) – 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 — Personal health device communication – Part 10424: Device specialization — Sleep apnoea breathing therapy equipment (SABTE).
Health informatics — Personal health device communication – Part 10425: Device specialization — 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 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 — Personal health device communication – Part 10427: Device specialization — 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 Jan-18 This standard establishes a normative definition of communication between devices containing a power source 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 Fees apply to access 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 — Personal health device communication – Part 10442: Device specialization — 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 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 — Personal health device communication – 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-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 — Personal health device communication – Part 10472: Device specialization — Medication monitor Category Standard Organisation ISO ID ISO/IEEE 11073-10472:2012 Type Standard Version 1 Access Fees apply to access 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 — Point-of-care medical device communication – Part 20101: Application profiles — Base standard Category Standard Organisation ISO ID ISO/IEEE 11073-20101:2004 Type Standard Version 1 Access Fees apply to access 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 — Device interoperability – Part 20601: Personal health device communication — Application profile — 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 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 — 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 Fees apply to access 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 — 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 Access Fees apply to access 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 — Point-of-care medical device communication – Part 30200: Transport profile — Cable connected Category Standard Organisation ISO ID ISO/IEEE 11073-30200:2004 Type Standard Access Fees apply to access 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 — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected – 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 Mar-15 This amendment applies to ISO/IEEE 11073-30200:2004 Health informatics — Point-of-care medical device communication – Part 30200: Transport profile — Cable connected.
Health informatics — Point-of-care medical device communication – Part 30400: Interface profile — Cabled Ethernet Category Standard Organisation ISO ID ISO/IEEE 11073-30400:2012 Type Standard Version 1 Access Fees apply to access 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 — Device interoperability – Part 40101: Foundational — Cybersecurity — 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 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 — Device interoperability – Part 40102: Foundational — Cybersecurity — 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 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 — Pandemic response —Guidelines 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 Jan-24 This standard provides comprehensive guidelines for pandemic response, particularly focusing on respiratory infection prevention and control in hospitals.
Health informatics — Personalized digital health — 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 Jun-23 This standard lists characteristics of digital therapeutics (DTx) software which generate and deliver medical interventions.
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 Fees apply to access 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.