SIST EN ISO 11073-20601:2011

SLOVENSKI STANDARD
SIST EN ISO 11073-20601:2011
01-maj-2011
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Health informatics - Personal health device communication - Part 20601: Application
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Ta slovenski standard je istoveten z: EN ISO 11073-20601:2011
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-20601:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-20601:2011

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SIST EN ISO 11073-20601:2011


EUROPEAN STANDARD
EN ISO 11073-20601

NORME EUROPÉENNE

EUROPÄISCHE NORM
March 2011
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 20601: Application profile - Optimized exchange protocol
(ISO/IEEE 11073-20601:2010)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 20601: Profil d'application - die persönliche Gesundheit - Teil 20601: Anwendungsprofil
Protocole d'échange optimisé (ISO/IEEE 11073- - Optimiertes Datenübertragungsprotokoll (ISO/IEEE
20601:2010) 11073-20601:2010)
This European Standard was approved by CEN on 23 April 2010.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a 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 European Standard 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-20601:2011: E
worldwide for CEN national Members.

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SIST EN ISO 11073-20601:2011
EN ISO 11073-20601:2011 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 11073-20601:2011
EN ISO 11073-20601:2011 (E)
Foreword
The text of ISO/IEEE 11073-20601:2010 has been prepared by Technical Committee ISO/TC 215 “Health
informatics” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
11073-20601:2011 by Technical Committee CEN/TC 251 “Health informatics” the secretariat of which is held
by NEN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by September 2011, and conflicting national standards shall be
withdrawn at the latest by September 2011.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-20601:2010 has been approved by CEN as a EN ISO 11073-20601:2011 without
any modification.

3

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SIST EN ISO 11073-20601:2011

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SIST EN ISO 11073-20601:2011

INTERNATIONAL ISO/IEEE
STANDARD 11073-20601
First edition
2010-05-01


Health informatics — Personal health
device communication —
Part 20601:
Application profile — Optimized
exchange protocol
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 20601: Profil d'application — Protocole d'échange optimisé




Reference number
ISO/IEEE 11073-20601:2010(E)

©
ISO 2010
©
IEEE 2010

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SIST EN ISO 11073-20601:2011
ISO/IEEE 11073-20601:2010(E)


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©  ISO 2010
©  IEEE 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective
address below.
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© ISO 2010 – All rights reserved
ii © IEEE 2010 – All rights reserved

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SIST EN ISO 11073-20601:2011
ISO/IEEE 11073-20601:2010(E)



Contents Page
Foreword. vi
Introduction. viii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 5
3. Definitions, acronyms, and abbreviations. 5
3.1 Definitions. 5
3.2 Acronyms and abbreviations. 5
4. Guiding principles. 6
5. Introduction to IEEE 11073 personal health devices . 7
5.1 General. 7
5.2 Domain information model (DIM). 8
5.3 Service model. 8
5.4 Communication model. 8
6. Personal health device DIM. 8
6.1 General. 8
6.2 Nomenclature usage. 9
6.3 Personal health object class definitions. 10
6.3.1 General . 10
6.3.2 MDS class . 12
6.3.3 Metric class. 18
6.3.4 Numeric class . 23
6.3.5 RT-SA class. 26
6.3.6 Enumeration class. 27
6.3.7 PM-store class . 30
6.3.8 PM-segment class. 34
6.3.9 Scanner classes . 37
6.4 Information model extensibility rules . 45
7. Personal health device service model . 45
7.1 General. 45
7.2 Association service . 46
7.3 Object access services. 46
7.4 Specific application of object access EVENT REPORT services for personal health devices . 47
7.4.1 General . 47
7.4.2 Confirmed and unconfirmed event reports. 47
© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved iii

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SIST EN ISO 11073-20601:2011
ISO/IEEE 11073-20601:2010(E)


7.4.3 Configuration event report . 47
7.4.4 Agent- and manager-initiated measurement data transmission . 49
7.4.5 Variable, fixed, and grouped format event reports . 50
7.4.6 Single-person and multiple-person event reports . 50
7.4.7 Temporarily stored measurements. 51
8. Communication model. 52
8.1 General. 52
8.2 System context . 52
8.3 Communications characteristics. 53
8.3.1 General . 53
8.3.2 Common communications characteristics . 55
8.3.3 Reliable communications characteristics. 55
8.3.4 Best-effort communications characteristics. 56
8.4 State machines. 56
8.4.1 Agent state machine . 56
8.4.2 Manager state machine . 59
8.4.3 Timeout variables . 60
8.5 Connected procedure. 61
8.5.1 General . 61
8.5.2 Entry conditions . 61
8.5.3 Normal procedures . 61
8.5.4 Exit conditions. 61
8.5.5 Error conditions. 62
8.6 Unassociated procedure . 62
8.6.1 General . 62
8.6.2 Entry conditions . 62
8.6.3 Normal procedures . 62
8.6.4 Exit conditions. 62
8.6.5 Error conditions. 62
8.7 Associating procedure. 63
8.7.1 General . 63
8.7.2 Entry conditions . 63
8.7.3 Normal procedures . 63
8.7.4 Exit conditions. 67
8.7.5 Error conditions. 67
8.7.6 Test association . 67
8.8 Configuring procedure . 69
8.8.1 General . 69
8.8.2 Entry conditions . 69
8.8.3 Normal procedures . 69
8.8.4 Exit conditions. 71
8.8.5 Error conditions. 71
8.9 Operating procedure. 72
8.9.1 General . 72
8.9.2 Entry conditions . 72
8.9.3 Normal procedures . 72
8.9.4 Exit conditions. 83
8.9.5 Error conditions. 83
8.10 Disassociating procedure . 85
8.10.1 General . 85
8.10.2 Entry conditions . 85
8.10.3 Normal procedures . 85
8.10.4 Exit conditions. 85
8.10.5 Error conditions. 86
8.11 Message encoding. 86
8.12 Time coordination . 86
© ISO 2010 – All rights reserved
iv © IEEE 2010 – All rights reserved

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SIST EN ISO 11073-20601:2011
ISO/IEEE 11073-20601:2010(E)


8.12.1 General . 86
8.12.2 Absolute time . 86
8.12.3 Relative time. 88
8.12.4 High-resolution relative time. 89
9. Conformance model. 89
9.1 Applicability . 89
9.2 Conformance specification. 90
9.3 Implementation conformance statements (ICSs) . 90
9.4 General conformance . 90
9.4.1 General ICS . 91
9.4.2 Minimum requirements ICS . 92
9.4.3 Service support ICS. 93
9.5 Device additions/extensions ICS. 94
9.5.1 General additions/extensions ICS. 94
9.5.2 Personal health device DIM object and class (POC) ICS. 95
9.5.3 POC attribute ICS. 95
9.5.4 POC behavior ICS . 96
9.5.5 POC notification ICS. 96
9.5.6 POC nomenclature ICS . 97
Annex A (normative) ASN.1 definitions . 98
Annex B (informative) Scale and range specification example . 130
Annex C (informative) The PM-store concept. 132
Annex D (informative) Transport profile types . 137
Annex E (normative) State tables . 140
Annex F (normative) Medical device encoding rules (MDER) . 151
Annex G (informative) Encoded data type definitions . 163
Annex H (informative) Examples. 182
Annex I (normative) Nomenclature codes . 190
Annex J (informative) Derivation and modification history. 194
Annex K (informative) Bibliography. 197


© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved v

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SIST EN ISO 11073-20601:2011
ISO/IEEE 11073-20601:2010(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.
ISO/IEEE 11073-20601 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-20601-2008). It was adopted by Technical
Committee ISO/TC 215, Health informatics, in parallel with its approval by the ISO member
bodies, under the “fast-track procedure” defined in the Partner Standards Development
Organization cooperation agreement between ISO and IEEE. Both parties are responsible for the
maintenance of this document.
ISO/IEEE 11073 consists of the following parts, under the general title Health informatics —
Personal health device communication (text in parentheses gives a variant of subtitle):
— Part 10101: (Point-of-care medical device communication) Nomenclature
— Part 10201: Domain information model
— Part 10404: Device specialization — Pulse oximeter
© ISO 2010 – All ri
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