• BS EN ISO 11073-10418:2014

    Current The latest, up-to-date edition.

    Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  30-11-2016

    Publisher:  British Standards Institution

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

    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)

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

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

    IEC 60601-2-46:2016 Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables
    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 60601-2-28:2017 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
    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 60601-2-39:2007 Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
    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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