I.S. EN ISO 11073-00103:2017
Current
The latest, up-to-date edition.
HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)
Hardcopy , PDF
English
01-01-2017
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.
National Foreword
European foreword
1 Overview
2 Definitions, acronyms, and abbreviations
3 PHD environment overview
4 Introduction into IEEE 11073 PHD standards (tutorial)
5 Utilizing IEEE 11073 PHD standards in the
development process
6 Conformance and interoperability
Annex A (informative) - Example use case regular blood
pressure control, detailed description
Annex B (informative) - Example transaction profiles
Annex C (informative) - Transport layer details
Annex D (informative) - Bibliography
Explains the landscape of transport-independent applications and information profiles for personal telehealth devices.
DocumentType |
Standard
|
Pages |
96
|
PublisherName |
National Standards Authority of Ireland
|
Status |
Current
|
Standards | Relationship |
EN ISO 11073-00103:2017 | Identical |
ISO/IEEE 11073-00103:2015 | Identical |
IEC 80001-1:2010 | Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
IEEE 11073-10421 : 2010 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10421: DEVICE SPECIALIZATION - PEAK EXPIRATORY FLOW MONITOR (PEAK FLOW) |
IEC TR 80002-1:2009 | Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software |
ISO/TR 27809:2007 | Health informatics Measures for ensuring patient safety of health software |
EN 60601-2-47:2015 | Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEEE 11073-10442 : 2008 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10442: DEVICE SPECIALIZATION - STRENGTH FITNESS EQUIPMENT |
ISO/IEEE 11073-30300:2004 | Health informatics — Point-of-care medical device communication — Part 30300: Transport profile — Infrared wireless |
ISO/IEEE 11073-10408:2010 | Health informatics — Personal health device communication — Part 10408: Device specialization — Thermometer |
IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEEE/ISO 11073-10420-2010 | IEEE Health informatics -- Personal health device communication Part 10420: Device specialization -- Body composition analyzer |
ISO/IEEE 11073-20101:2004 | Health informatics — Point-of-care medical device communication — Part 20101: Application profiles — Base standard |
IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
IEEE 11073-10417-2015 | IEEE Health informatics -- Personal health device communication Part 10417: Device Specialization -- Glucose Meter |
ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
IEEE 11073-10471 : 2008 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10471: DEVICE SPECIALIZATION - INDEPENDENT LIVING ACTIVITY HUB |
ISO/IEC 27002:2013 | Information technology Security techniques Code of practice for information security controls |
EN 60601-1-1:2001 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
EN 62304:2006/A1:2015 | MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
EN 60601-2-27:2014 | Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
EN 12470-3:2000+A1:2009 | Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device |
EN 12470-5:2003 | Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
EN ISO 18778:2009 | Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005) |
EN 60601-2-30:2000 | Medical electrical equipment - Part 2-30: Particular requirements for the safety, including essential performance, of automatic cycling non-invasive blood pressure monitoring equipment |
ISO/IEEE 11073-20601:2016 | Health informatics — Personal health device communication — Part 20601: Application profile — Optimized exchange protocol |
IEEE 11073-10441-2013 | Health Informatic--Personal health device communication Part 10441: Device specialization--Cardiovascular fitness and activity monitor |
EN ISO 17510-1:2009 | Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007) |
EN 62366 : 2008 AMD 1 2015 | MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
ISO 9919:2005 | Medical electrical equipment Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use |
ISO/IEEE 11073-10407:2010 | Health informatics — Personal health device communication — Part 10407: Device specialization — Blood pressure monitor |
ISO/IEEE 11073-10404:2010 | Health informatics — Personal health device communication — Part 10404: Device specialization — Pulse oximeter |
IEEE 11073-10418-2011 | IEEE Standard - Health informatics--Personal health device communication Part 10418: Device specialization--International Normalized Ratio (INR) monitor |
EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
ISO/HL7 27931:2009 | Data Exchange Standards — Health Level Seven Version 2.5 — An application protocol for electronic data exchange in healthcare environments |
IEEE 11073-20601-2014 REDLINE | IEEE Health informatics--Personal health device communication - Part 20601: Application profile- Optimized Exchange Protocol |
ISO/IEEE 11073-30200:2004 | Health informatics — Point-of-care medical device communication — Part 30200: Transport profile — Cable connected |
EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
ISO/IEEE 11073-10101:2004 | Health informatics Point-of-care medical device communication Part 10101: Nomenclature |
IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
ISO/TS 25238:2007 | Health informatics Classification of safety risks from health software |
ISO/IEEE 11073-10415:2010 | Health informatics — Personal health device communication — Part 10415: Device specialization — Weighing scale |
IEEE 11073-10472 : 2010 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10472: DEVICE SPECIALIZATION - MEDICATION MONITOR |
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