• BS EN ISO 11073-10419:2016

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

    Available format(s): 

    Superseded date:  06-09-2023

    Language(s): 

    Published date:  05-12-2018

    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
    5 Insulin pump device concepts and modalities
    6 Insulin pump domain information model
    7 Insulin pump service model
    8 Insulin pump 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 (normative) - Schedule-store class
    Annex F (normative) - Schedule class ASN.1 definitions
    Annex G (informative) - The schedule-store concept
    Annex H (informative) - Scedule communication model
    Annex I (informative) - Protocol data unit examples

    Abstract - (Show below) - (Hide below)

    Defines a normative definition of communication between personal telehealth insulin pump 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.

    Scope - (Show below) - (Hide below)

    The scope of this standard is to establish a normative definition of communication between personal telehealth insulin pump 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. It leverages work done in other ISO/IEEE 11073 standards including existing terminology, information profiles, 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 functionality of personal telehealth insulin pump devices.

    In the context of personal health devices, an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.

    This standard provides the data modeling according to the ISO/IEEE 11073-20601 standard, and does not specify the measurement method.

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

    Committee IST/35
    Document Type Standard
    Publisher British Standards Institution
    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
    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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