Active Standard

IEEE/ISO/IEC 11073-10101-2020

IEEE/ISO/IEC International Standard - Health informatics-Device interoperability-Part 10101: Point-of-care medical device communication-Nomenclature

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) and personal health devices (PHD) medical device communication (MDC), this standard provides the nomenclature that supports both the domain information model and service model components of the standards family, as well as the semantic content exchanged with medical devices. The nomenclature is specialized for patient vital signs information representation and medical device informatics, with major areas including concepts for electrocardiograph (ECG), haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as specialized units of measurement, general device events, alarms, and body sites. The standard defines both the architecture and major components of the nomenclature, along with extensive definitions for each conceptual area.

Sponsor Committee
EMB/11073 - IEEE 11073 Standards Committee
Status
Active Standard
Adoption of
11073-10101-2019
History
Published:
2020-08-28
Adopted:
2020-08-28

Working Group Details

Society
IEEE Engineering in Medicine and Biology Society
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Sponsor Committee
EMB/11073 - IEEE 11073 Standards Committee
Working Group
PoCD - Point-of-Care Devices
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IEEE Program Manager
Tom Thompson
Contact
Working Group Chair
Stefan Schlichting

P11073-10101b

Health informatics -- Point-of-care medical device communication -- Part 10101: Nomenclature Amendment 2: Additional definitions

The scope of this standard is to define a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object oriented information model that is for medical device communications.

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P11073-10101c

Standard for Health informatics--Point-of-care medical device communication - Part 10101: Nomenclature Amendment 3: Additional definitions

This amendment extends IEEE Std 11073 10101 to include additional terms, primarily related to endoscopy and high-frequency surgical equipment but also other key medical devices. It also includes generic terms for all participants in a Service-Oriented Device Connectivity (SDC) system.

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P11073-10103

Health Informatics - Point-of-care Medical Device Communication Part 10103: Nomenclature - Implantable Device, Cardiac

To support terminology for implantable cardiac devices this standard extends the base nomenclature provided in IEEE 11073. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system.

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P11073-10107

Standard for Nomenclature for External Control of Medical Devices

The base IEEE 11073-10101 nomenclature is extended by this standard to provide definitions of commands for external control. It is designed to be used in conjunction with IEEE 11073 standards, including ISO/IEEE 11073-10207, ISO/IEEE 11073-10201 and ISO/IEEE 11073-20601, and may be used with other standards or independently. The main areas addressed by this standard include commands to modify the characteristics and behavior of point-of-care (PoC) medical devices, such as modes of operation, contextual information, and settings

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P11073-10700

IEEE Draft Standard - Health Informatics -- Device Interoperability -- Part 10700: Point-of-Care Medical Device Communication -- Standard for Base Requirements for Participants in a Service-Oriented Device Connectivity (SDC) System

MEDICAL DEVICEs that offer a communication interface as specified by the IEEE 11073 Service-oriented Device Connectivity (SDC) standards can be integrated into a HEALTH IT SYSTEM to jointly execute SYSTEM FUNCTIONs. However, implementing the IEEE 11073 SDC communication protocol is not sufficient to demonstrate safety, effectiveness, and security of SYSTEM FUNCTIONs resulting from the combination of SYSTEM FUNCTION CONTRIBUTIONs from two or more MEDICAL DEVICEs. SDC PARTICIPANT KEY PURPOSEs (PKPs) are sets of requirements that support MANUFACTURERs in making valid assumptions about BICEPS PARTICIPANTs from other MANUFACTURERs. This common understanding allows for the MANUFACTURERs to perform RISK MANAGEMENT, verification, and USABILITY ENGINEERING for the safe use of SYSTEM FUNCTIONs. This standard specifies requirements for the allocation of responsibilities to SDC BASE PARTICIPANTs.

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P11073-10701

IEEE Draft Standard for Health Informatics - Device Interoperability - Part 10701: Point-of-Care Medical Device Communication - Metric Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System

This standard defines the requirements for Participants in a Service-Oriented Device Connectivity (SDC) System that comprises a network of point-of-care (PoC) medical devices and medical IT systems to exchange metric data in a manner that improves safe, secure and effective contribution to the functionality of a distributed system.

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P11073-10702

Standard for Alert Provisioning by Participants in a Service-Oriented Device Connectivity (SDC) System

This standard defines the requirements for Participants in a Service-Oriented Device Connectivity (SDC) System that comprises a network of point-of-care (PoC) medical devices and medical IT systems to exchange alert data in a manner that improves safe, secure and effective contribution to the functionality of a distributed system.

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P11073-10703

Standard for External Control by Participants in a Service-Oriented Device Connectivity (SDC) System

This standard defines the requirements for Participants in a Service-Oriented Device Connectivity (SDC) System that comprises a network of point-of-care (PoC) medical devices and medical IT systems to exchange external control commands in a manner that improves safe, secure and effective contribution to the functionality of a distributed system.

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P11073-10720

Module Specifications for a Service-Oriented Medical Device Exchange Architecture

Within the context of the ISO/IEEE 11073 family of standards for medical device communication, the scope of this standard is to define normative requirements for the modular components of participants in a networked system of point-of-care (PoC) medical devices and medical IT systems in order that they contribute safely and effectively to distributed system functionality through the exchange of data or control commands. The standard specifies the network representation of participant modules by restricting optionality of the IEEE 11073-10207 Domain Information and Service Model, defines the use of specific term codes from the IEEE 11073 Nomenclature Standards, and specifies communication behavior. This standard does not address the definition of exhaustive specializations for specific devices.

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P11073-10721

Device Specialization - High Frequency (200 kHz to < 5 MHz) Surgical Equipment

Within the context of the ISO/IEEE 11073 family of standards for medical device communication, the scope of this standard is to define the normative requirements for high frequency surgical equipment that participates in a service-oriented networked system of point-of-care (PoC) medical devices and medical IT systems in order that they contribute safely and effectively to distributed system functionality through the exchange of data or control commands. The standard specifies the network representation of the device by restricting optionality of the IEEE 11073-10207 Domain Information and Service Model, defines the use of specific term codes from the IEEE 11073 Nomenclature Standards, and specifies communication behavior.

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P11073-10722

Device Specialization - Endoscopic camera

Within the context of the ISO/IEEE 11073 family of standards for medical device communication, the scope of this standard is to define the normative requirements for an endoscopic camera that participates in a service-oriented networked system of point-of-care (PoC) medical devices and medical IT systems in order that they contribute safely and effectively to distributed system functionality through the exchange of data or control commands. The standard specifies the network representation of the device by restricting optionality of the IEEE 11073-10207 Domain Information and Service Model, defines the use of specific term codes from the IEEE 11073 Nomenclature Standards, and specifies communication behavior.

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P11073-10723

Device Specialization - Endoscopic light source

Within the context of the ISO/IEEE 11073 family of standards for medical device communication, the scope of this standard is to define the normative requirements for an endoscopic light source that participates in a service-oriented networked system of point-of-care (PoC) medical devices and medical IT systems in order that they contribute safely and effectively to distributed system functionality through the exchange of data or control commands. The standard specifies the network representation of the device by restricting optionality of the IEEE 11073-10207 Domain Information and Service Model, defines the use of specific term codes from the IEEE 11073 Nomenclature Standards, and specifies communication behavior.

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P11073-10724

Device Specialization - Endoscopic insufflator

Within the context of the ISO/IEEE 11073 family of standards for medical device communication, the scope of this standard is to define the normative requirements for an endoscopic insufflator that participates in a service-oriented networked system of point-of-care (PoC) medical devices and medical IT systems in order that they contribute safely and effectively to distributed system functionality through the exchange of data or control commands. The standard specifies the network representation of the device by restricting optionality of the IEEE 11073-10207 Domain Information and Service Model, defines the use of specific term codes from the IEEE 11073 Nomenclature Standards, and specifies communication behavior.

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P11073-10725

Health Informatics -- Device Interoperability -- Part 10725: Point-of-Care Medical Device Communication -- Device Specialization - Suction and Irrigation Pump

Within the context of the ISO/IEEE 11073 family of standards for medical device communication, this standard defines normative requirements for a pump that has suction and/or irrigation functionality and that participates in a service-oriented networked system of Point-of-Care (PoC) medical devices and medical IT systems. The exchange of data or control commands enables the pump to contribute safely and effectively to distributed system functionality. The standard specifies the network representation of the device by restricting optionality of the IEEE 11073-10207 Domain Information and Service Model, defines the use of specific terms from the IEEE 11073 Nomenclature Standards, and specifies behavior that is related to communication aspects.

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11073-10101-2019

IEEE Standard for Health informatics--Point-of-care medical device communication - Part 10101: Nomenclature

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) and personal health devices (PHD) medical device communication (MDC), this standard provides the nomenclature that supports both the domain information model and service model components of the standards family, as well as the semantic content exchanged with medical devices. The nomenclature is specialized for patient vital signs information representation and medical device informatics, with major areas including concepts for electrocardiograph (ECG), haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as specialized units of measurement, general device events, alarms, and body sites. The standard defines both the architecture and major components of the nomenclature, along with extensive definitions for each conceptual area.

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11073-10102-2012

Health informatics – Point-of-care medical device communication Part 10102: Nomenclature –Annotated ECG

The base IEEE 11073-10101 Nomenclature is extended by this standard to provide support for ECG annotation terminology. It may be used either in conjunction with other IEEE 11073 standards (e.g., ISO/IEEE 11073-10201:2001) or independently with other standards. The major subject areas addressed by the nomenclature include ECG beat annotations, wave component annotations, rhythm annotations, and noise annotations. Additional u201cglobalu201d and u201cper-leadu201d numeric observation identifiers, ECG lead systems, and additional ECG lead identifiers also are defined.

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11073-10103-2012

Health informatics--Point-of-care medical device communication Part 10103: Nomenclature--Implantable device, cardiac

The base nomenclature provided in IEEE 11073 to support terminology for implantable cardiac devices is extended in this standard. Devices within the scope of this nomenclature are implantable devices such as pacemakers, defibrillators, devices for cardiac resynchronization therapy, and implantable cardiac monitors. The discrete terms necessary to convey a clinically relevant summary of the information obtained during a device interrogation are defined in this nomenclature. To improve workflow efficiencies, cardiology and electrophysiology practices require the management of summary interrogation information from all vendor devices and systems in a central system such as an Electronic Health Records (EHR) system or a device clinic management system. To address this requirement, the Implantable Device, Cardiac (IDC) Nomenclature defines a standard-based terminology for device data. The nomenclature facilitates the transfer of data from the vendor proprietary systems to the clinic EHR or device clinic management system. Additional files can be found at http://standards.ieee.org/downloads/11073/11073-10103-2012/ if not attached to the PDF.

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11073-10201-2018

IEEE Standard for Health Informatics - Point-of-care medical device communication - Part 10201: Domain Information Model

Within the context of the ISO/IEEE 11073 family of standards for point-of-care medical device communication, an abstract, object-oriented domain information model that specifies the structure of exchanged information, as well as the events and services that are supported by each type of object, is provided in this standard. All data structure elements are specified using abstract syntax (ASN.1) and may be applied to many different implementation technologies, transfer syntaxes, and application service models. Core subjects include medical, alert, system, patient, control, archival, communication, and extended services. Model extensibility is supported, and a conformance model and statement template is provided.

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11073-10207-2017

IEEE Health informatics--Point-of-care medical device communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication

Within the context of the ISO/IEEE 11073™ family of standards for point-of-care medical device communication, a Participant Model derived from the ISO/IEEE11073-10201 Domain Information Model is provided in this standard. The Participant Model specifies the structure of medical information objects. This standard also defines an abstract Communication Model to support the exchange of medical information objects. All elements of the Participant Model and Communication Model are specified using XML Schema. Core subjects of the Participant Model comprise modelling of medical device-related data, e.g., measurements and settings, alert systems, contextual information (e.g., patient demographics and location information), remote control, and archival information. Model extensibility is provided inherently through the use of XML Schema.textual information like patient demographics and location information, remote control, and archival. Model extensibility is provided inherently through the use of XML Schema. (Additional files are available for this standard at http://standards.ieee.org/downloads/11073/)

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11073-20701-2018

IEEE Standard - Health informatics--Point-of-care medical device communication - Part 20701: Service-Oriented Medical Device Exchange Architecture and Protocol Binding

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, an architecture for service-oriented distributed PoC medical devices and medical IT systems is defined. This standard defines a binding of the Participant, Discovery, and Communication Model defined in IEEE Std 11073-10207(TM) to the profile for transport over Web Services defined in IEEE Std 11073-20702(TM). Moreover, a binding to Network Time Protocol (NTP) and Differentiated Services (DiffServ) is defined for time synchronization and transport Quality of Service requirements.

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11073-20702-2016

IEEE Standard for Health informatics--Point-of-care medical device communication Part 20702: Medical Devices Communication Profile for Web Services

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (PoC) medical device communication, a communication protocol specification for a distributed system of PoC medical devices and medical IT systems that need to exchange data, or safely control networked PoC medical devices by profiling Web Service specifications, is defined by this standard. Additional Web Service specifications are part of this standard.

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1073.1.1.1-2004

IEEE Standard for Health Informatics - Point-of-care medical device communication - Part 10101: Nomenclature

Replaced by ISO/IEEE 11073-10101-2004. Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical device communication (MCD), this standard provides the nomenclature that supports both the domain information model and service model components of the standards family, as well as the semantic content exchanged with medical devices. The nomenclature is specialized for patient vital signs information representation and medical device informatics, with major areas including concepts for electrocardiograph (ECG), haemodynamics, respiration, blood gas, urine, fluid-related metrics, and neurology, as well as specialized units of measurement, general device events, alarms, and body sites. The standard defines both the architecture and major components of the nomenclature, along with extensive definitions for each conceptual area.

Learn More

11073-10101a-2015

IEEE Standard Health informatics--Point-of-care medical device communication --Part 10101: Nomenclature Amendment 1: Additional Definitions

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical device communication (MDC), the nomenclature defined by the base ISO/IEEE 11073-10101:2004 nomenclature standard is extended by this amendment. Significant extensions to support haemodynamics, respiration, ventilation and anesthesia monitoring, blood gas, urine, fluid-related metrics, and neurology, as well as units of measurements and measurement sites, are included. Formal definitions for observation identifiers used by the IEEE 11073 Personal Health Device standards and additional attributes for reporting their regulatory and certification status are also captured and provided. Information attributes to support alert communication and accurate medical device time synchronization and timekeeping are also defined.

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11073-10201-2004

ISO/IEEE International Standard for Health Informatics - Point-of-care medical device communication - Part 10201: Domain information model

Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC) medical device communication (MDC), this standard provides an abstract object-oriented domain information model that specifies the structure of exchanged information, as well as the events and services that are supported by each object. All elements are specified using abstract syntax (ASN.1) and may be applied to many different implementation technologies, transfer syntaxes, and application service models. Core subjects include medical, alert, system, patient, control, archival, communication, and extended services. Model extensibility is supported, and a conformance model and statement template is provided.

Learn More

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