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I.S. EN ISO 11073-00103:2017

Current

Current

The latest, up-to-date edition.

HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 00103: OVERVIEW (ISO/IEEE 11073-00103:2015)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

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.

€99.00
Excluding VAT

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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