SIST EN ISO 11073-10424:2016 PDF

Overview

SIST EN ISO 11073-10424:2016 (ISO/IEEE 11073-10424:2016) defines a normative, plug-and-play communication profile for Sleep Apnoea Breathing Therapy Equipment (SABTE) within the ISO/IEEE 11073 family for personal health device communication. The standard specifies how SABTE devices (agents) interact with managers such as cell phones, personal computers, personal health appliances and set‑top boxes, focusing on consistent terminology, information models, and restricted options to maximize interoperability in telehealth and home-care environments. SABTE is defined as a therapeutic device that delivers breathing pressure to alleviate sleep apnoea, intended for home use by lay operators.

Key technical topics and requirements

• Agent / Manager model: Defines roles and expected interactions between SABTE devices (agents) and managers (mobile apps, gateways, PC software).
• Terminology and information models: Leverages ISO/IEEE 11073 terminology and data models to ensure semantic consistency of measurements and device state.
• Application profile and transport alignment: Maps SABTE functionality to applicable parts of the 11073 application profile and transport standards to enable reliable data exchange.
• Controlled optionality: Restricts optional features from base frameworks by mandating specific term codes, data formats and behaviors to reduce variability and improve plug‑and‑play interoperability.
• Common core communication functionality: Specifies the minimal, normative set of messages and data elements required for SABTE monitoring, configuration and event reporting in telehealth scenarios.
• Telehealth focus: Emphasizes behaviors and formats suitable for remote monitoring, data logging and device configuration when professional supervision is not continuously available.

Practical applications

• Enabling out‑of‑the‑box connectivity between CPAP/BiPAP and consumer managers (smartphones, home gateways).
• Facilitating remote monitoring and adherence tracking of sleep apnoea therapy for clinicians and telehealth platforms.
• Standardizing data exchange for home‑care ecosystems, electronic health records (EHR) ingestion and device management.
• Supporting device certification, conformance testing and interoperability labs that validate SABTE implementations.

Who uses this standard

• Medical device manufacturers building SABTE (CPAP/BiPAP) products seeking standardized communications.
• Mobile and gateway app developers integrating SABTE data into telehealth apps and home monitoring systems.
• Healthcare IT integrators and system vendors aiming to ingest device data into clinical systems or EHRs.
• Test labs and certification bodies evaluating plug‑and‑play interoperability and conformance.
• Regulatory and procurement teams that require adherence to recognized device communication standards.

Related standards

• ISO/IEEE 11073 family (terminology, information models, application profiles and transport standards). Note: Implementation may involve consideration of intellectual property and patent licensing as described in ISO/IEEE documentation.

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