BS EN ISO 11073-00103:2017
Current
The latest, up-to-date edition.
Health informatics. Personal health device communication Overview
Hardcopy
English
04-30-2017
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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
Defines the landscape of transport-independent applications and information profiles for personal telehealth devices.
| Committee |
IST/35
|
| DevelopmentNote |
Renumbers and supersedes BS ISO/IEEE 11073-00103. 2017 Version incorporates corrigendum to BS ISO/IEEE 11073-00103. (04/2017)
|
| DocumentType |
Standard
|
| Pages |
88
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e.g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.
| Standards | Relationship |
| ISO/IEEE 11073-00103:2015 | Identical |
| EN ISO 11073-00103:2017 | 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 |
| EN ISO 9919:2009 | Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use (ISO 9919:2005) |
| 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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