BS EN ISO IEEE 11073-10419-2023 PDF

Full title and description

BS EN ISO/IEEE 11073-10419:2023 — Health informatics. Personal health device communication. Device specialization. Insulin pump. This British/European adoption of the ISO/IEEE 11073 device-specialization standard defines a normative communication model between personal telehealth insulin pump devices (agents) and managers (for example smartphones, personal computers or other personal health appliances) to enable plug-and-play interoperability across telehealth environments.

Abstract

This standard specifies the domain information model, object classes, message profiles and constrained behaviours required for interoperable communication of insulin pump devices using the ISO/IEEE 11073 family (using ISO/IEEE 11073-20601 application profile and MDER encoding). It restricts optionality in base frameworks to favour interoperability, describes data sets (real-time samples, stored/persistent metric stores, schedules), and prescribes agent/manager interaction patterns for discovery, configuration and data reporting. The document does not prescribe clinical methods for insulin delivery — it defines data and communications semantics only.

General information

• Status: Published / Active (British Standard / EN adoption).
• Publication date: 6 September 2023 (BS EN publication/adoption date shown by BSI catalogues and distributors).
• Publisher: British Standards Institution (BSI) — published as BS EN ISO/IEEE 11073-10419:2023; equivalent text originates in the ISO/IEEE 11073 family.
• ICS / categories: 35.240.80 — IT applications in health care technology / Health informatics.
• Edition / version: EN adoption 2023 (transposition of the ISO/IEEE 11073 device-specialization content; the ISO/IEEE device-specialization edition in the family is associated with the 2019/2018 IEEE/ISO work).
• Number of pages: 136 pages (BS catalogue / product listings).

Scope

The standard defines the device-specialization model for insulin pumps as Personal Health Devices (PHDs) within the ISO/IEEE 11073 framework: object classes and extensions, the insulin‑pump Domain Information Model (DIM), message and service behaviour for association/initial configuration, real-time and historical data reporting, schedule and persistent metric stores, enumerations and term codes, and profile constraints designed to ensure interoperable implementations of agent (pump) and manager behaviours. It is focused on communications and data semantics and does not specify clinical performance or insulin-delivery methods.

Key topics and requirements

• Agent / Manager model: definitions of roles and required behaviours to support discovery, association and configuration between pump (agent) and manager (phone, gateway, PC).
• Domain Information Model (DIM): insulin‑pump object classes, class extensions, MDS object, numeric and enumeration objects, real‑time sample arrays.
• Data stores and scheduling: persistent metric (PM‑store) and schedule‑store definitions for stored and scheduled therapy/measurement data.
• Message and encoding rules: use of ISO/IEEE 11073-20601 application profile and Medical Device Encoding Rules (MDER) for message formatting and protocol behaviour.
• Restricted optionality and profiles: constrained choices and profiles to reduce implementation variability and enable plug-and-play interoperability across vendors.
• Nomenclature and identifiers: allocation and use of specific term codes and identifiers required for consistent semantics.
• Implementation guidance: message sequence examples, protocol PDU examples and illustrative association/configuration exchanges to support implementers.

Typical use and users

Primary users include medical device manufacturers (insulin pump vendors), embedded and firmware engineers, device‑to‑app integrators, mobile and telehealth application developers, interoperability architects, test labs and certification bodies, and clinical IT teams integrating personal health devices into care pathways or remote-monitoring solutions. Regulators and procurement teams may reference the standard for interoperability expectations.

Related standards

Key related standards in the ISO/IEEE 11073 family and ecosystem include ISO/IEEE 11073-20601 (application profile / optimized exchange protocol and MDER), ISO/IEEE 11073-10101 (nomenclature), other device-specialization parts in the 11073‑104xx series (for example device specializations for glucose meters, blood pressure monitors and others), and relevant transport/profiles that carry 11073 PHD messages. Implementers commonly use this standard together with the 20601 base profile and the family’s nomenclature resources.

Keywords

insulin pump, personal health device (PHD), device specialization, ISO/IEEE 11073, domain information model (DIM), MDER, agent, manager, interoperability, persistent metric store, schedule‑store, health informatics.

FAQ

Q: What is this standard?

A: BS EN ISO/IEEE 11073-10419:2023 is the British/European adoption of the ISO/IEEE 11073 device-specialization standard that defines communication semantics and profiles for insulin pump personal health devices to enable interoperable data exchange with managers (apps, gateways, PCs).

Q: What does it cover?

A: It covers the domain information model for insulin pumps, required object classes and attributes, message encoding and sequencing (MDER / 20601 profile), stored and scheduled data constructs, nomenclature codes, and constrained profiles/behaviours for agent and manager roles. It does not define clinical measurement or insulin‑delivery techniques.

Q: Who typically uses it?

A: Device manufacturers, firmware and software engineers, telehealth app developers, systems integrators, test laboratories, interoperability/certification bodies and clinical IT teams integrating PHDs into care solutions.

Q: Is it current or superseded?

A: The BS EN publication (2023) is a current EN/BS adoption of the ISO/IEEE 11073 insulin‑pump device-specialization material; it replaces the earlier 2016 British/EN adoption and aligns with the ISO/IEEE device‑specialization work in the 11073 family (the family also records a 2019 edition of the device specialization text). Consult national standards bodies for confirmation of national status and any corrigenda.

Q: Is it part of a series?

A: Yes — it is one part of the ISO/IEEE 11073 Personal Health Device (PHD) series (the 11073-104xx device‑specialization parts) and is intended to be used together with the core application/profile standards (for example 11073-20601) and the 11073 nomenclature resources.

Q: What are the key keywords?

A: Insulin pump, personal health device, device specialization, 11073, MDER, domain information model, interoperability, agent, manager.