SIST EN ISO 11073-10101:2005/A1:2018
(Amendment)Health informatics - Point-of-care medical device communication - Part 10101: Nomenclature - Amendment 1: Additional definitions (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)
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe – 10101. del: Nomenklatura (ISO/IEEE 11073-10101:2004/Amd 1:2017)
General Information
Relations
Standards Content (Sample)
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
2
---------------------- 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.
3
---------------------- 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
form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without
prior written permission. Permission can be requested from IEEE at the address below.
ISO copyright office Institute of Electrical and Electronics Engineers, Inc
Ch. de Blandonnet 8 • CP 401 3 Park Avenue, New York
CH-1214 Vernier, Geneva, Switzerland NY 10016-5997, USA
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
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non‐governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
IEEE Standards documents are developed within the IEEE Societies and the Standards Coordinating
Committees of the IEEE Standards Association (IEEE‐SA) Standards Board. The IEEE develops its standards
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
process and establishes rules to promote fairness in the consensus development process, the IEEE does not
independently evaluate, test, or verify the accuracy of any of the information contained in its standards.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is called to the possibility that implementation of this standard may require the use of subject
matter covered by patent rights. By publication of this standard, no position is taken with respect to the
existence or validity of any patent rights in connection therewith. ISO/IEEE is not responsible for identifying
essential patents or patent claims for which a license may be required, for conducting inquiries into the legal
validity or scope of patents or patent claims or determining whether any licensing terms or conditions
provided in connection with submission of a Letter of Assurance or a Patent Statement and Licensing
Declaration Form, if any, or in any licensing agreements are reasonable or non‐discriminatory. Users of this
standard are expressly advised that determination of the validity of any patent rights, and the risk of
infringement of such rights, is entirely their own responsibility. Further information may be obtained from
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
bodies, under the “fast‐track procedure” defined in the Partner Standards Development Organization
cooperation agreement between ISO and IEEE. IEEE is responsible for the maintenance of this document with
participation and input from ISO/IEC national bodies.
© IEEE 2015 – All rights reserved iii
---------------------- Page: 9 ----------------------
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
xx
The Institute of Electrical and Electronics Engineers, Inc.
3 Park Avenue, New York, NY 10016-5997, USA
Copyright © 2015 by The Institute of Electrical and Electronics Engineers, Inc.
All rights reserved. Published 9 December 2015. Printed in the United States of America.
IEEE is a registered trademark in the U.S. Patent & Trademark Office, owned by The Institute of Electrical and Electronics Engineers,
Incorporated.
PDF: ISBN 978-1-5044-0119-7 STD20525
Print: ISBN 978-1-5044-0120-3 STDPD20525
IEEE prohibits discrimination, harassment and bullying. For more information, visit http://www.ieee.org/web/aboutus/whatis/policies/p9-26.html.
No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior written permission
of the publisher.
vi
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)
Important Notices and Disclaimers Concerning IEEE Standards Documents
IEEE documents are made available for use subject to important notices and legal disclaimers. These notices
and disclaimers, or a reference to this page, appear in all standards and may be found under the heading
“Important Notice” or “Important Notices and Disclaimers Concerning IEEE Standards Documents.”
Notice and Disclaimer of Liability Concerning the Use of IEEE Standards
Documents
IEEE Standards documents (standards, recommended practices, and guides), both full-use and trial-use, are
developed within IEEE Societies and the Standards Coordinating Committees of the IEEE Standards
Association (“IEEE-SA”) Standards Board. IEEE (“the Institute”) develops its standards through a
consensus development process, approved by the American National Standards Institute (“ANSI”), which
brings together volunteers representing varied viewpoints and interests to achieve the final product.
Volunteers are not necessarily members of the Institute and participate without compensation from IEEE.
While IEEE administers the process and establishes rules to promote fairness in the consensus development
process, IEEE does not independently evaluate, test, or verify the accuracy of any of the information or the
soundness of any judgments contained in its standards.
IEEE does not warrant or represent the accuracy or content of the material contained in its standards, and
expressly disclaims all warranties (express, implied and statutory) not included in this or any other
document relating to the standard, including, but not limited to, the warranties of: merchantability; fitness
for a particular purpose; non-infringement; and quality, accuracy, effectiveness, currency, or completeness
of material. In addition, IEEE disclaims any and all conditions relating to: results; and workmanlike effort.
IEEE standards documents are supplied “AS IS” and “WITH ALL FAULTS.”
Use of an IEEE standard is wholly voluntary. The existence of an IEEE standard does not imply that there
are no other ways to produce, test, measure, purchase, market, or provide other goods and services related
to the scope of the IEEE standard. Furthermore, the viewpoint expressed at the time a standard is approved
and issued is subject to change brought about through developments in the state of the art and comments
received from users of the standard.
In publishing and making its standards available, IEEE is not suggesting or rendering professional or other
services for, or on behalf of, any person or entity nor is IEEE undertaking to perform any duty owed by any
other person or entity to another. Any person utilizing any IEEE Standards document, should rely upon his
or her own independent judgment in the exercise of reasonable care in any given circumstances or, as
appropriate, seek the advice of a competent professional in determining the appropriateness of a given
IEEE standard.
IN NO EVENT SHALL IEEE BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL,
EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO:
PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS;
OR BUSINESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,
WHETHER IN CONTRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR
OTHERWISE) ARISING IN ANY WAY OUT OF THE PUBLICATION, USE OF, OR RELIANCE
UPON ANY STANDARD, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND
REGARDLESS OF WHETHER SUCH DAMAGE WAS FORESEEABLE.
Translations
The IEEE consensus development process involves the review of documents in English only. In the event
that an IEEE standard is translated, only the English version published by IEEE should be considered the
approved IEEE standard.
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)
Official statements
A statement, written or oral, that is not processed in accordance with the IEEE-SA Standards Board
Operations Manual shall not be considered or inferred to be the official position of IEEE or any of its
committees and shall not be considered to be, or be relied upon as, a formal position of IEEE. At lectures,
symposia, seminars, or educational courses, an individual presenting information on IEEE standards shall
make it clear that his or her views should be considered the personal views of that individual rather than the
formal position of IEEE.
Comments on standards
Comments for revision of IEEE Standards documents are welcome from any interested party, regardless of
membership affiliation with IEEE. However, IEEE does not provide consulting information or advice
pertaining to IEEE Standards documents. Suggestions for changes in documents should be in the form of a
proposed change of text, together with appropriate supporting comments. Since IEEE standards represent a
consensus of concerned interests, it is important that any responses to comments and questions also receive
the concurrence of a balance of interests. For this reason, IEEE and the members of its societies and
Standards Coordinating Committees are not able to provide an instant response to comments or questions
except in those cases where the matter has previously been addressed. For the same reason, IEEE does not
respond to interpretation requests. Any person who would like to participate in revisions to an IEEE
standard is welcome to join the relevant IEEE working group.
Comments on standards should be submitted to the following address:
Secretary, IEEE-SA Standards Board
445 Hoes Lane
Piscataway, NJ 08854 USA
Laws and regulations
Users of IEEE Standards documents should consult all applicable laws and regulations. Compliance with
the provisions of any IEEE Standards document does not imply compliance to any applicable regulatory
requirements. Implementers of the standard are responsible for observing or referring to the applicable
regulatory requirements. IEEE does not, by the publication of its standards, intend to urge action that is not
in compliance with applicable laws, and these documents may not be construed as doing so.
Copyrights
IEEE draft and approved standards are copyrighted by IEEE under U.S. and international copyright laws.
They are made available by IEEE and are adopted for a wide variety of both public and private uses. These
include both use, by reference, in laws and regulations, and use in private self-regulation, standardization,
and the promotion of engineering practices and methods. By making these documents available for use and
adoption by public authorities and private users, IEEE does not waive any rights in copyright to the
documents.
Photocopies
Subject to payment of the appropriate fee, IEEE will grant users a limited, non-exclusive license to
photocopy portions of any individual standard for company or organizational internal use or individual,
non-commercial use only. To arrange for payment of licensing fees, please contact Copyright Clearance
Center, Customer Service, 222 Rosewood Drive, Danvers, MA 01923 USA; +1 978 750 8400. Permission
to photocopy portions of any individual standard for educational classroom use can also be obtained
through the Copyright Clearance Center.
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)
Updating of IEEE Standards documents
Users of IEEE Standards documents should be aware that these documents may be superseded at any time
by the issuance of new editions or may be amended from time to time through the issuance of amendments,
corrigenda, or errata. An official IEEE document at any point in time consists of the current edition of the
document together with any amendments, corrigenda, or errata then in effect.
Every IEEE standard is subjected to review at least every ten years. When a document is more than ten
years old and has not undergone a revision process, it is reasonable to conclude that its contents, although
still of some value, do not wholly reflect the present state of the art. Users are cautioned to check to
determine that they have the latest edition of any IEEE standard.
In order to determine whether a given document is the current edition and whether it has been amended
through the issuance of amendments, corrigenda, or errata, visit the IEEE-SA Website at
http://ieeexplore.ieee.org/xpl/standards.jsp or contact IEEE at the address listed previously. For more
information about the IEEE SA or IEEE’s standards development process, visit the IEEE-SA Website at
http://standards.ieee.org.
Errata
Errata, if any, for all IEEE standards can be accessed on the IEEE-SA Website at the following URL:
http://standards.ieee.org/findstds/errata/index.html. Users are encouraged to check this URL for errata
periodically.
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken by the IEEE with respect to
the existence or validity of any patent rights in connection therewith. If a patent holder or patent applicant
has filed a statement of assurance via an Accepted Letter of Assurance, then the statement is listed on the
IEEE-SA Website at http://standards.ieee.org/about/sasb/patcom/patents.html. Letters of Assurance may
indicate whether the Submitter is willing or unwilling to grant licenses under patent rights without
compensation or under reasonable rates, with reasonable terms and conditions that are demonstrably free of
any unfair discrimination to applicants desiring to obtain such licenses.
Essential Patent Claims may exist for which a Letter of Assurance has not been received. The IEEE is not
responsible for identifying Essential Patent Claims for which a license may be required, for conducting
inquiries into the legal validity or scope of Patents Claims, or determining whether any licensing terms or
conditions provided in connection with submission of a Letter of Assurance, if any, or in any licensing
agreements are reasonable or non-discriminatory. Users of this standard are expressly advised that
determination of the validity of any patent rights, and the risk of infringement of such rights, is entirely
their own responsibility. Further information may be obtained from the IEEE Standards Association.
ix
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
x
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.
xi
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.