Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature - Amendment 1: Additional definitions (ISO/IEEE 11073-10101:2004/Amd 1:2017)

Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil 10101: Nomenklatur - Änderung (ISO/IEEE 11073-10101:2004/Amd 1:2017)

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 10101: Nomenclature - Amendement 1 (ISO/IEEE 11073-10101:2004/Amd 1:2017)

Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe – 10101. del: Nomenklatura (ISO/IEEE 11073-10101:2004/Amd 1:2017)

General Information

Status
Withdrawn
Publication Date
08-Jan-2018
Withdrawal Date
08-Oct-2020
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
07-Oct-2020
Due Date
30-Oct-2020
Completion Date
09-Oct-2020

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SLOVENSKI STANDARD
SIST EN ISO 11073-10101:2005/A1:2018
01-februar-2018
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe –
10101. del: Nomenklatura (ISO/IEEE 11073-10101:2004/Amd 1:2017)
Health informatics - Point-of-care medical device communication - Part 10101:

Nomenclature - Amendment 1: Additional definitions (ISO/IEEE 11073-10101:2004/Amd

1:2017)

Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil

10101: Nomenklatur - Änderung (ISO/IEEE 11073-10101:2004/Amd 1:2017)

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -

Partie 10101: Nomenclature - Amendement 1 (ISO/IEEE 11073-10101:2004/Amd
1:2017)
Ta slovenski standard je istoveten z: EN ISO 11073-10101:2005/A1:2017
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-10101:2005/A1:2018 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
EN ISO 11073-
EUROPEAN STANDARD
10101:2005/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2017
ICS 01.040.35; 35.240.80
English Version
Health informatics - Point-of-care medical device
communication - Part 10101: Nomenclature - Amendment
1: Additional definitions (ISO/IEEE 11073-
10101:2004/Amd 1:2017)

Informatique de santé - Communication entre Medizinische Informatik - Kommunikation

dispositifs médicaux sur le site des soins - Partie patientennaher medizinischer Geräte - Teil 10101:

10101: Nomenclature - Amendement 1 (ISO/IEEE Nomenklatur - Änderung 1 (ISO/IEEE 11073-

11073-10101:2004/Amd 1:2017) 10101:2004/Amd 1:2017)

This amendment A1 modifies the European Standard EN ISO 11073-10101:2005; it was approved by CEN on 13 April 2017.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of

this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This amendment exists in three official versions (English, French, German). A version in any other language made by translation

under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the

same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,

Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10101:2005/A1:2017 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
EN ISO 11073-10101:2005/A1:2017 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
EN ISO 11073-10101:2005/A1:2017 (E)
European foreword

This document (EN ISO 11073-10101:2005/A1:2017) has been prepared by Technical Committee

ISO/TC 215 “Health informatics” in collaboration with Technical Committee CEN/TC 251 “Health

informatics” the secretariat of which is held by NEN.

This Amendment to the European Standard EN ISO 11073-10101:2005 shall be given the status of a

national standard, either by publication of an identical text or by endorsement, at the latest by May

2018, and conflicting national standards shall be withdrawn at the latest by May 2018.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,

France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,

Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
Endorsement notice

The text of ISO/IEEE 11073-10101:2004/Amd1:2017 has been approved by CEN as EN ISO 11073-

10101:2005/A1:2017 without any modification.
---------------------- Page: 5 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
---------------------- Page: 6 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
INTERNATIONAL ISO/IEEE
STANDARD 11073-10101
First edition
2004‐12‐15
AMENDMENT 1
2017‐10
Health informatics — Point-of-care medical
device communication —
Part 10101:
Nomenclature
AMENDMENT 1: Additional definitions
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 10101: Nomenclature
AMENDEMENT 1: Définitions supplementaires
Reference number
ISO/IEEE 11073‐10101:2004/Amd 1:2017(E)
IEEE 2015
---------------------- Page: 7 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© IEEE 2015

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any

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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org stds.ipr@ieee.org
www.iso.org www.ieee.org
ii © IEEE 2015 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out through

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IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating

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through a consensus development process, approved by the American National Standards Institute, which

brings together volunteers representing varied viewpoints and interests to achieve the final product. Volunteers

are not necessarily members of the Institute and serve without compensation. While the IEEE administers the

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The main task of technical committees is to prepare International Standards. Draft International Standards

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Attention is called to the possibility that implementation of this standard may require the use of subject

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ISO or the IEEE Standards Association.

Amendment 1 to ISO/IEEE 11073‐10101:2004/Amd 1:2017 was prepared by the 11073 Committee of the

Engineering in Medicine and Biology Society of the IEEE (as IEEE 11073‐10101:2004). It was adopted by

Technical Committee ISO/TC 215, Health informatics, in parallel with its approval by the ISO/IEC national

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© IEEE 2015 – All rights reserved iii
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SIST EN ISO 11073-10101:2005/A1:2018
---------------------- Page: 10 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
IEEE Std 11073-10101a™-2015
(Amendment to
ISO/IEEE 11073-10101:2004)
Health informatics—Point-of-care medical device communication
Part 10101: Nomenclature
Amendment 1: Additional Definitions
Sponsor
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 5 December 2015
IEEE-SA Standards Board
---------------------- Page: 11 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)

Abstract: Within the context of the ISO/IEEE 11073 family of standards for point-of-care (POC)

medical device communication (MDC), the nomenclature defined by the base ISO/IEEE 11073-

10101:2004 nomenclature standard is extended by this amendment. Significant extensions to

support haemodynamics, respiration, ventilation and anesthesia monitoring, blood gas, urine,

fluid-related metrics, and neurology, as well as units of measurements and measurement sites,

are included. Formal definitions for observation identifiers used by the IEEE 11073 Personal

Health Device standards and additional attributes for reporting their regulatory and certification

status are also captured and provided. Information attributes to support alert communication and

accurate medical device time synchronization and timekeeping are also defined.

Keywords: alert communication, anesthesia, blood gas, codes, Continua, fluid-related metrics,

haemodynamics, IEEE 11073-10101a, IHE PCD, information model, ISO/IEEE 11073-10101,

measurement sites, medical device certification, medical device communication, neurology,

nomenclature, NTP, ontology, patient, PCHA, Personal Connected Health Alliance, POC, point-

of-care, respiration, semantics, service model, terminology, time synchronization, timekeeping,

units of measure, urine, ventilation
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of the publisher.
Copyright © 2015 IEEE. All rights reserved.
---------------------- Page: 12 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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vii
Copyright © 2015 IEEE. All rights reserved.
---------------------- Page: 13 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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viii
Copyright © 2015 IEEE. All rights reserved.
---------------------- Page: 14 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
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Copyright © 2015 IEEE. All rights reserved.
---------------------- Page: 15 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Participants

At the time this standard was submitted to the IEEE-SA Standards Board for approval, the Upper Layers

Working Group had the following membership:
Jan Wittenber, Chair
Paul Schluter and Todd Cooper, Vice Chairs
Malcolm Clarke Norman Jones Stefan Schlichting
Steven Dain Kenneth Marks John Walsh
Kenneth Fuchs John Rhoads Daidi Zhong
Jeff Rinda

The following members of the individual balloting committee voted on this standard. Balloters may have

voted for approval, disapproval, or abstention.
Susan Burgess Werner Hoelzl Stefan Schlichting
Keith Chow Noriyuki Ikeuchi Paul Schluter
Malcolm Clarke Atsushi Ito Janek Schumann
Gion Durisch Piotr Karocki Eugene Stoudenmire
Christoph Fischer Daniel Kraehenbuehl Walter Struppler
Kenneth Fuchs Kenneth Marks John Walsh
John Garguilo Melvin Reynolds J. Wiley
Joel Goergen John Rhoads Jan Wittenber
Randall Groves Bartien Sayogo Oren Yuen
Kai Hassing Daidi Zhong

When the IEEE-SA Standards Board approved this standard on 5 December 2015, it had the following

membership:
John D. Kulick, Chair
Jon Walter Rosdahl, Vice Chair
Richard H. Hulett, Past Chair
Konstantinos Karachalios, Secretary
Masayuki Ariyoshi Joseph L. Koepfinger* Stephen J. Shellhammer
Ted Burse David J. Law Adrian P. Stephens
Stephen Dukes Hung Ling Yatin Trivedi
Jean-Philippe Faure Andrew Myles Phillip Winston
J. Travis Griffith T. W. Olsen Don Wright
Gary Hoffman Glenn Parsons Yu Yuan
Michael Janezic Ronald C. Petersen Daidi Zhong
Annette D. Reilly
*Member Emeritus
Copyright © 2015 IEEE. All rights reserved.
---------------------- Page: 16 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Introduction

This introduction is not part of IEEE Std 11073-10101a™-2015, Health informatics—Point-of-care medical device

communication—Part 10101: Nomenclature—Amendment 1: Additional Definitions.

ISO/IEEE 11073 standards enable communication between medical devices and external computer systems.

They provide automatic and detailed electronic data capture of patient vital signs information and device

operational data. The primary goals are to:

 Provide real-time plug-and-play interoperability for patient-connected medical devices

 Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-

care, in all health care environments

This amendment extends the nomenclature originally defined by the base IEEE Std 11073-10101:2004

nomenclature standard. It reflects the continued innovation in medical device and system design for the

past decade and is based on a highly successful collaboration with the following organizations:

 Integrating the Healthcare Enterprise (IHE) Patient Care Devices (PCD) domain
 Personal Connected Health Alliance (PCHA, formerly Continua Health Alliance)

 ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee 4, Terminology and semantics

In addition, other vendors and standards development and profiling organizations have contributed to and

have recognized the value of this work and the benefit it provides to the user and provider communities and

to the patients that we ultimately serve.
This nomenclature amendment includes significant extensions to support:
 haemodynamics
 respiratory, ventilation and anesthesia monitoring
 blood gas, urine, fluid chemistry and other fluid-related metrics
 neurology
 units of measurements and measurement sites
 new medical device types, including infant warmers and incubators
This amendment also provides:

 formal definitions for observation identifiers used by IEEE 11073 Personal Health Devices

 attributes for reporting medical device regulatory and certification status
 attributes to support alert communication

 attributes to support accurate medical device time synchronization and timekeeping

NOTES as used in this amendment (preceding editorial instructions) are not meant to be included in the

rollup or part of the editorial instructions. They are used solely to provide informative guidance and

background to the reader as to why certain changes were made.
Copyright © 2015 IEEE. All rights reserved.
---------------------- Page: 17 ----------------------
SIST EN ISO 11073-10101:2005/A1:2018
ISO/IEEE 11073-10101:2004/Amd 1:2017(E)
Contents

4. Terms and definitions .................................................................................................................................. 2

5. Symbols (and abbreviated terms) ................................................................................................................ 2

Annex A (normative) Nomenclature semantics ............................................................................................... 4

A.5 Nomenclature, data dictionary, and codes for vital signs devices (Block A) ....................................... 5

A.6 Terminology and codes for units of measurement (Block B) .............................................................. 8

A.7 Nomenclature, data dictionary, and codes for metrics (measurements and enumerations)

(Block C) ........................................................................................................................................... 14

A.7.3 Nomenclature and codes for hemodynamic monitoring measurements ..................................... 14

A.7.4 Nomenclature and codes for respiratory, ventilator and anesthesia measurements .................... 17

A.7.4.18 Gas concentration and partial pressure measurements ..................................................... 17

A.7.4.19 Inspiratory breath type classification................................................................................ 18

A.7.4.20 Nomenclature and code table ........................................................................................... 20

A.7.4.21 Nomenclature and codes for nebulizers
...

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