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    I.S. EN ISO 11073-10418:2014

    Current The latest, up-to-date edition.

    HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2014

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    European foreword
    Foreword
    1 Overview
    2 Normative references
    3 Definitions, acronyms,
       and abbreviations
    4 Introduction to ISO/IEEE 11073
       personal health devices
    5 INR monitor device concepts
       and modalities
    6 International Normalized Ratio
       monitor domain information model
    7 INR monitor service model
    8 INR 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
    Annex F (informative) - IEEE list
            of participants

    Abstract - (Show below) - (Hide below)

    Describes a normative definition of communication between personal telehealth International Normalized Ratio (INR) devices (agents) and managers (e.g. cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    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 60601-2-37:2007+AMD1:2015 CSV Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
    IEC 60601-2-10:2012+AMD1:2016 CSV Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators
    IEC 60601-2-21:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
    IEC 60601-2-7:1998 Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators
    IEC 60601-2-19:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
    IEC 60601-2-3:2012+AMD1:2016 CSV Medical electrical equipment - Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
    IEC 60601-2-5:2009 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
    IEC 60601-2-9:1996 Medical electrical equipment - Part 2: Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-2-47:2012 Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
    IEC 60601-2-50:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-50: Particular requirementsfor the basic safety and essential performance of infant phototherapy equipment
    IEC 60601-2-26:2012 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
    ISO/IEEE 11073-20101:2004 Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard
    IEC 60601-2-8:2010+AMD1:2015 CSV Medical electrical equipment - Part 2-8: Particular requirements forthe basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
    IEC 60601-2-23:2011 Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
    IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
    IEC 60601-2-20:2009+AMD1:2016 CSV Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators
    IEC 60601-2-14:1989 Medical electrical equipment. Part 2: Particular requirements for the safety of electroconvulsive therapy equipment
    IEC 60601-2-30:1999 Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment
    IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
    IEC 60601-2-22:2007+AMD1:2012 CSV Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
    IEC 60601-2-34:2011 Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment
    IEC 60601-2-46 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-46: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF OPERATING TABLES
    IEC 60601-2-39:2007 MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT
    IEC 60601-2-6:2012+AMD1:2016 CSV Medical electrical equipment - Part 2-6: Particular requirements forthe basic safety and essential performance of microwave therapy equipment
    IEC 60601-2-31:2008+AMD1:2011 CSV Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
    IEC 60601-2-4:2010 Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 60601-2-16 : 4.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT
    IEC 60601-2-2:2017 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    IEC 60601-2-40:2016 Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
    IEC 60601-2-13:2003+AMD1:2006 CSV Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
    IEC 60601-2-28 : 3.0 MEDICAL ELECTRICAL EQUIPMENT - PART 2-28: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY TUBE ASSEMBLIES FOR MEDICAL DIAGNOSIS
    ISO/IEEE 11073-20601:2016 Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol
    IEC 60601-2-32:1994 Medical electrical equipment - Part 2: Particular requirements for the safety of associated equipment of X-ray equipment
    IEC 60601-2-51:2003 Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs
    IEC 60601-2-35:1996 Medical electrical equipment - Particular requirements for the safety of blankets, pads and mattresses intended for heating in medical use
    IEC 60601-2-15:1988 Medical electrical equipment. Part 2: Particular requirements for the safety of capacitor discharge X-ray generators
    IEC 60601-2-1:2009+AMD1:2014 CSV Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
    IEC 60601-2-41:2009+AMD1:2013 CSV Medical electrical equipment - Part 2-41: Particular requirementsfor the basic safety and essential performance of surgical luminaires and luminaires for diagnosis
    IEC 60601-2-43:2010+AMD1:2017 CSV Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures
    IEC 60601-2-27:2011 Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
    IEC 60601-2-38:1996 Medical electrical equipment - Part 2: Particular requirementsfor the safety of electrically operated hospital beds
    IEC 60601-2-17:2013 Medical electrical equipment - Part 2-17: Particular requirements for the basic safety and essential performance of automatically-controlled brachytherapy afterloading equipment
    IEC 60601-2-25:2011 Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
    IEC 60601-2-24:2012 Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers
    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
    IEC 60601-2-29:2008 Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
    IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
    IEEE 11073-20601A : 2010 HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 20601: APPLICATION PROFILE - OPTIMIZED EXCHANGE PROTOCOL - AMENDMENT 1
    IEC 60601-2-49:2011 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60601-2-45:2011+AMD1:2015 CSV Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
    IEC 60601-2-36:2014 Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
    IEC 60601-2-11:2013 Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
    IEC 60601-2-44:2009+AMD1:2012+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
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