ISO/IEEE 11073-10418:2014
Current
Current
The latest, up-to-date edition.
Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Published date
02-13-2014
ISO/IEEE 11073-10418:2013 establishes 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. Work done in other ISO/IEEE 11073 standards is leveraged, including existing terminology, information profiles, application profile standards and transport standards. The use of specific term codes, formats and behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability is specified. A common core of functionality of INR devices is defined in ISO/IEEE 11073-10418:2013. In the context of personal health devices, the measurement of the prothrombin time (PT) that is used to assess the level of anticoagulant therapy and its presentation as the International Normalized Ratio compared to the prothrombin time of normal blood plasma is referred to in INR monitoring. Applications of the INR monitor include the management of the therapeutic level of anticoagulant used in the treatment of a variety of conditions. The data modeling and its transport shim layer according to ISO/IEEE 11073-20601:2010 are provided by ISO/IEEE 11073:10418:2013, and the measurement method is not specified.
| Committee |
ISO/TC 215
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| DocumentType |
Standard
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| Pages |
64
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| ProductNote |
THIS STANDARD ALSO HAVE CORRECTED VERSION FOR ENGLISH AND FRENCH FOR THE YEAR 2014.
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| PublisherName |
International Organization for Standardization
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| Status |
Current
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| Standards | Relationship |
| NF EN ISO 11073-10418 : 2014 | Identical |
| NBN EN ISO 11073-10418 : 2014 | Identical |
| NS EN ISO 11073-10418 : 2014 AC 2016 | Identical |
| I.S. EN ISO 11073-10418:2014 | Identical |
| PN EN ISO 11073-10418 : 2014 AC 2017 | Identical |
| SN EN ISO 11073-10418 : 2014 COR 2017 | Identical |
| UNI EN ISO 11073-10418 : 2014 | Identical |
| NEN-EN-ISO/IEEE 11073-10418:2014 | Identical |
| SS-EN ISO 11073-10418:2014 | Identical |
| UNE-EN ISO 11073-10418:2014 | Identical |
| BS EN ISO 11073-10418:2014 | Identical |
| EN ISO 11073-10418:2014/AC:2016 | Identical |
| DIN EN ISO 11073-10418:2014-06 | Identical |
| 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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