ISO/IEEE 11073-10424:2016 PDF

Overview

ISO/IEEE 11073-10424:2016 defines a normative communication profile for Sleep Apnoea Breathing Therapy Equipment (SABTE) within the ISO/IEEE 11073 family of personal health device standards. The standard specifies how SABTE devices (agents) communicate with managers - such as smartphones, personal computers, set‑top boxes, and personal health appliances - to enable plug-and-play interoperability in telehealth and home‑care environments. SABTE are devices that deliver therapeutic breathing pressure (e.g., CPAP/BiPAP-type therapy) primarily for use by lay operators outside direct professional supervision.

Key technical topics and requirements

• Agent–Manager Model: Normative definitions for interactions between SABTE agents and remote managers to support monitoring, configuration, and data exchange.
• Terminology and Information Models: Uses and references ISO/IEEE 11073 terminology and information models to ensure consistent semantics for measurements, device states, and therapy parameters.
• Application Profiles and Transports: Leverages appropriate portions of existing 11073 application profile and transport standards for reliable data transport in telehealth contexts.
• Restricted Optionality for Interoperability: Specifies precise term codes, data formats, and behaviors, intentionally reducing optional features in base frameworks to improve multi‑vendor interoperability.
• Common Core Functionality: Defines a minimal, common core of communication features that SABTE devices must support to be interoperable in personal health device ecosystems.
• Telehealth and Home Use Focus: Emphasizes behaviors and data exchange patterns suitable for remote monitoring, therapy adherence tracking, and non‑clinical use.

Practical applications

• Enabling seamless remote monitoring of CPAP/BiPAP therapy adherence and device performance through consumer devices (phones, gateways).
• Integrating SABTE data into telehealth platforms, electronic health records (EHRs), and care‑management systems.
• Supporting manufacturer implementations that want standardised device‑to‑app communication for firmware updates, therapy configuration, and event logging.
• Facilitating interoperability testing, certification, and regulatory submission where standardized communication reduces integration risk.

Who should use this standard

• Medical device manufacturers of CPAP, BiPAP, and other sleep apnoea breathing therapy equipment.
• Software developers building mobile apps, gateways, or cloud services that collect SABTE data.
• Telehealth integrators, hospitals, and home‑care providers implementing remote respiratory therapy programs.
• Test labs, regulatory bodies, and standards specialists assessing interoperability and compliance.

Related standards

• Other parts of the ISO/IEEE 11073 family (terminology, device information models, application profiles, transport standards) that this specialization references and constrains for SABTE interoperability.

Keywords: ISO/IEEE 11073-10424:2016, SABTE, sleep apnoea breathing therapy equipment, personal health device communication, plug-and-play interoperability, telehealth, CPAP, medical device communication.