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BS EN ISO 11073-00103:2017

Current
Current

The latest, up-to-date edition.

Health informatics. Personal health device communication Overview
Available format(s)

Hardcopy

Language(s)

English

Published date

04-30-2017

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.

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.

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

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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