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 |
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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 |
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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 |
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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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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 |
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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 |
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