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 allow for manufacturers to have certain expectations about BICEPS participants from other manufacturers. This common understanding enables the manufacturers to perform risk management, verification, validation, and usability engineering for the safe use of system functions. This standard defines requirements for SDC metric participants in an SDC system that comprises an IT network of medical devices to enable safe and secure contribution to system functions based on the exchange of metric information.
- Standard Committee
- EMB/11073 - IEEE 11073 Standards Committee
- Status
- Active Standard
- PAR Approval
- 2019-03-21
- Board Approval
- 2022-12-03
- History
-
- Published:
- 2023-09-22
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
- Standard Committee
- EMB/11073 - IEEE 11073 Standards Committee
- Working Group
-
PoCD - Point-of-Care Devices
- IEEE Program Manager
- Patrycja Jarosz
Contact Patrycja Jarosz - Working Group Chair
- Stefan Schlichting
Other Activities From This Working Group
Current projects that have been authorized by the IEEE SA Standards Board to develop a standard.
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.
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
P11073-10207-2017/Cor 1
IEEE Draft Standard - Health Informatics - Point-of-Care Medical Device Communication Part 10207: Domain Information and Service Model for Service-Oriented Point-of-Care Medical Device Communication - Corrigendum 1
The IEEE 11073-10207-2017 standard falls within the context of the ISO/IEEE 11073™ family of standards for point-of-care medical device communication. In this standard, a Participant Model is derived from the ISO/IEEE 11073-10201 Domain Information Model. The Participant Model specifies the structure of medical information objects. Additionally, the standard defines an 4 abstract Communication Model to facilitate the exchange of medical information objects. Both the Participant Model and Communication Model elements are specified using XML Schema. The core subjects covered by the Participant Model include the modeling of medical device-related 7 data (such as measurements and settings), alert systems, contextual information (such as patient demographics and location), remote control, and archival information. XML Schema is utilized to provide extensibility to the model. The corrigendum for this standard comprises fixes related to definition terms, requirements, and a significant retrofit of the versioning concept. It ensures that the standard remains accurate and up-to-date, addressing any issues that may have arisen since its initial publication.
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.
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.
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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