ISO/IEEE 11073-10419:2019 PDF
Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
Health informatics — Personal health device communication — Part 10419: Device specialization — Insulin pump
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 130
- Дата публикации:
- 22 марта 2019 г.
- Издание:
- ISO/IEEE IS 11073 edition 2 version 1
- ICS:
- 35.240.80
This standard establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, application profile standards, and transport standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability. This standard defines a common core functionality of personal telehealth insulin pump devices. In the context of personal health devices (PHDs), an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy. This standard provides the data modeling according to ISO/IEEE 11073-20601 and does not specify the measurement method.
Abstract
Overview
ISO/IEEE 11073-10419:2019 - Device specialization - Insulin pump defines how personal telehealth insulin pump devices (agents) communicate with managers (for example, cell phones, personal computers, personal health appliances, set‑top boxes) to enable plug‑and‑play interoperability. It is part of the ISO/IEEE 11073 family for personal health device communication and provides a normative communication definition, data modeling aligned with ISO/IEEE 11073-20601, and a common core functionality for continuous subcutaneous insulin infusion (CSII) therapy devices. The standard specifies term codes, data formats, and behavioral rules for telehealth insulin pump communications but does not prescribe measurement methods.
Key technical topics and requirements
- Plug‑and‑play interoperability: Defines communication behaviors to allow insulin pumps to interoperate with managers without custom integration.
- Agent/Manager model: Clarifies roles of the insulin pump (agent) and external compute engines or apps (managers).
- Data modeling: Requires use of the ISO/IEEE 11073-20601 framework for object and communication model consistency.
- Restricted optionality: Narrows optional elements from base frameworks by specifying required term codes, formats, and behaviors-reducing ambiguity and improving interoperability.
- Terminology and profiles: Leverages existing ISO/IEEE 11073 terminology, information profiles, application profiles, and transport standards to ensure consistent semantics across implementations.
- Normative definitions: Provides prescriptive rules for message contents and expected behaviors in telehealth environments (note: the standard does not define how insulin delivery is measured).
Practical applications
- Enabling secure, standardized wireless or wired communication between insulin pumps and mobile health apps, gateways, or home health systems.
- Supporting remote monitoring, therapy data exchange, and integration with personal health records (PHRs) or clinical systems.
- Facilitating certification and conformance testing for device manufacturers and interoperability testing labs.
- Reducing integration costs for healthcare IT vendors by standardizing message formats and behaviors.
Who should use this standard
- Medical device manufacturers developing personal telehealth insulin pumps (CSII).
- Mobile app and gateway developers creating manager software for pump data capture, analysis, or user interfaces.
- Healthcare integrators and clinical IT teams working on device-to-EHR/PHR connectivity and telehealth platforms.
- Regulatory and testing bodies assessing interoperability and conformance to personal health device communication standards.
Related standards
- ISO/IEEE 11073-20601 - Base data model and transport framework used for device data modeling.
- Other parts of the ISO/IEEE 11073 family (terminology, application profiles, transport standards) that the insulin pump specialization leverages.
Keywords: ISO/IEEE 11073-10419:2019, insulin pump communication, personal health device communication, insulin pump interoperability, ISO/IEEE 11073-20601, CSII, personal telehealth devices.
Технические детали
- Технический комитет
- ISO/TC 215 - Health informatics
- SKU
- ISO/IEEE 11073-10419:2019
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