I.S. EN ISO 11073-10406:2012
Current
The latest, up-to-date edition.
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012)
Hardcopy , PDF
English
01-01-2012
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.
Foreword
1. Overview
2. Normative references
3. Definitions, acronyms, and abbreviations
4. Introduction to ISO/IEEE 11073 personal
health devices
5. Basic ECG (1- to 3-lead ECG) device concepts
and modalities
6. Basic ECG (1- to 3-lead ECG) domain
information model
7. Basic ECG (1- to 3-lead ECG) service model
8. Basic ECG (1- to 3-lead ECG) 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
Describes a normative definition of the communication between personal basic electrocardiograph (ECG) devices and managers (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a manner that enables plug-and-play interoperability.
DocumentType |
Standard
|
Pages |
81
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Standards | Relationship |
ISO/IEEE 11073-10406:2012 | Identical |
EN ISO 11073-10406:2012 | Identical |
IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
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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 |
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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 |
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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 |
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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 |
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IEC 60601-2-4:2010 | Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
IEC 60601-2-16 : 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 |
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 |
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 |
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 60601-2-45:2011+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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