• EN ISO 11073-10425:2016

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) (ISO 11073-10425:2016)

    Available format(s): 

    Superseded date:  31-01-2017

    Language(s): 

    Published date:  29-06-2016

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    1 Overview
    2 Normative references
    3 Definitions, acronyms, and abbreviations
    4 Introduction to IEEE 11073[TM] personal health devices
    5 Glucose monitoring concepts and modalities
    6 Continuous glucose monitor domain information model
    7 Continuous glucose monitor service model
    8 Continuous glucose monitor 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)

    This standard establishes a normative definition of communication between personal health continuous glucose monitor (CGM) devices (agents) and managers [e.g., cell phones, personal computers (PCs), personal health appliances, set top boxes] in a manner that enables plug-and-play interoperability. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, informationprofiles, 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 of CGM devices. In this context, CGM refers to the measurement of the level of glucose in the body on a regular (typically 5 minute) basis through a sensor continuously attached to the person.

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

    Committee CEN/TC 251
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    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
    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
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