• BS EN ISO 11073-10424:2016

    Current The latest, up-to-date edition.

    Health informatics. Personal health device communication Device specialization. Sleep apnoea breathing therapy equipment (SABTE)

    Available format(s): 

    Language(s): 

    Published date:  10-09-2018

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    1 Overview
    2 Normative references
    3 Definitions, acronyms, and abbreviations
    4 Introduction to ISO/IEEE 11073 personal health devices
       standards
    5 SABTE device concepts and modalities
    6 Sleep apnoea breathing therapy equipment domain
       Information model
    7 SABTE service model
    8 SABTE communication model
    9 Test associations
    10 Conformance
    Annex A (informative) - Bibliography
    Annex B (normative) - Any additional ASN.1 definitions
    Annex C (normative) - Allocation of identifiers
    Annex D (informative) - Message sequence examples
    Annex E (informative) - Protocol data unit examples

    Abstract - (Show below) - (Hide below)

    Defines a normative definition of the communication between sleep apnoea breathing therapy equipment and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability.

    Scope - (Show below) - (Hide below)

    Within the context of the ISO/IEEE11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment 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 appropriate portions of existing standards including ISO/IEEE11073 terminology, information models, 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 of communication functionality for sleep apnoea breathing therapy equipment. In this context, sleep apnoea breathing therapy equipment are defined as devices that are intended to alleviate the symptoms of a patient who suffers from sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment are primarily used in the home health-care environment by a lay operator without direct professional supervision.

    General Product Information - (Show below) - (Hide below)

    Committee IST/35
    Document Type Standard
    Publisher British Standards Institution
    Status Current

    Standards Referencing This Book - (Show below) - (Hide below)

    IEC 80001-1:2010 Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEEE 11073-20601-2014 REDLINE IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO/IEEE 11073-10101:2004 Health informatics Point-of-care medical device communication Part 10101: Nomenclature
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