• ISO/IEEE 11073-10424:2016

    Current The latest, up-to-date edition.

    Health informatics Personal health device communication Part 10424: Device specialization Sleep apnoea breathing therapy equipment (SABTE)

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s): 

    Published date:  03-06-2016

    Publisher:  International Organization for Standardization

    Add To Cart

    Abstract - (Show below) - (Hide below)

    Within the context of the ISO/IEEE 11073 family of standards for device communication, a normative definition of the communication between sleep apnea breathing therapy equipment (SABTE) 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, is established in this standard. It leverages appropriate portions of existing standards including ISO/IEEE 11073 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 SABTE. In this context, SABTE is defined as a device that is intended to alleviate the symptoms of a patient who suffers from sleep apnea by delivering a therapeutic breathing pressure to the patient. SABTE is primarily used in the home health-care environment by a lay operator without direct professional supervision.

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

    Document Type Standard
    Publisher International Organization for Standardization
    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
    ISO/IEEE 11073-20101:2004 Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard
    EN 62304:2006/A1:2015 MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015)
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO/IEEE 11073-20601:2016 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
    IEEE 11073-20601A : 2010 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 20601: APPLICATION PROFILE - OPTIMIZED EXCHANGE PROTOCOL - AMENDMENT 1
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective