EN ISO 11073-10417:2014

SLOVENSKI STANDARD
01-julij-2014
1DGRPHãþD
SIST EN ISO 11073-10417:2011
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10417. del:
Specialne naprave - Glukometer (ISO 11073-10417:2014)
Health informatics - Personal health device communication - Part 10417: Device
specialization - Glucose meter (ISO 11073-10417:2014)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10417: Gerätespezifikation: Blutzuckermessgerät (ISO 11073-10417:2014)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10417: Spécialisation des dispositifs: Glucomètre (ISO 11073-10417:2014)
Ta slovenski standard je istoveten z: EN ISO 11073-10417:2014
ICS:
11.040.55 'LDJQRVWLþQDRSUHPD Diagnostic equipment
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11073-10417
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2014
ICS 35.240.80 Supersedes EN ISO 11073-10417:2011
English Version
Health informatics - Personal health device communication - Part
10417: Device specialization - Glucose meter (ISO/IEEE 11073-
10417:2014, Corrected version 2014-05-01)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation von Geräten für
médicaux sur le site des soins - Partie 10417: die persönliche Gesundheit - Teil 10417:
Spécialisation des dispositifs - Glucomètre (ISO/IEEE Gerätespezifikation: Blutzuckermessgerät (ISO/IEEE
11073-10417:2014, Version corrigée 2014-05-01) 11073-10417:2014, korrigierte Fassung 2014-05-01)
This European Standard was approved by CEN on 14 December 2013.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-10417:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Foreword
This document (EN ISO 11073-10417:2014) 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 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 2014, and conflicting national standards shall be
withdrawn at the latest by September 2014.
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.
This document supersedes EN ISO 11073-10417:2011.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10417:2014, Corrected version 2014-05-01 has been approved by CEN as
INTERNATIONAL ISO/IEEE
STANDARD 11073-
6HFRQG edition
201
Health informatics — Personal health
device communication —
Part 10417:
Device specialization: Glucose meter
Informatique de santé — Communication entre dispositifs de santé
personnels
Partie 10417: Spécialisation des dispositifs: Glucomètre

Reference number
ISO/IEEE 11073-10417:2013(E)
©
IEEE 2013
ISO/IEEE 11073-10417:2013(E)
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ISO/IEEE 11073-10417:2013(E)
Foreword
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Association.
ISO/IEEE 11073-10417 was prepared by the Substations Committee of the IEEE Power Engineering Society
of the IEEE (as IEEE 1686-2007). It was adopted by Technical Committee ISO/TC 215, Respiratory and
anaesthetic equipment, 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. IEEE is responsible for the maintenance of this document with participation and input from ISO
member bodies.
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 00103: Overview
 Part 10101: (Point-of-care medical device communication) Nomenclature
 Part 10102: (Point-of-care medical device communication) Nomenclature — Annotated ECG
 Part 10103: (Point-of-care medical device communication) — Nomenclature — Implantable device,
cardiac
 Part 10201: (Point-of-care medical device communication) Domain information model
 Part 10404: Device specialization — Pulse oximeter
© IEEE 2013 – All rights reserved iii

ISO/IEEE 11073-10417:2013(E)
 Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG)
 Part 10407: Device specialization — Blood pressure monitor
 Part 10408: Device specialization — Thermometer
 Part 10415: Device specialization — Weighing scale
 Part 10417: Device specialization — Glucose meter
 Part 10418: Device specialization — International Normalized Ratio (INR) monitor
 Part 10420: Device specialization — Body composition analyzer
 Part 10421: Device specialization — Peak expiratory flow monitor (peak flow)
 Part 10441: Device specialization — Cardiovascular fitness and activity monitor
 Part 10471: Device specialization — Independant living activity hub
 Part 10472: Device specialization — Medication monitor
 Part 20101: (Point-of-care medical device communication) Application profiles — Base standard
 Part 20601: Application profile — Optimized exchange protocol
 Part 30200: (Point-of-care medical device communication) Transport profile — Cable connected
 Part 30300: (Point-of-care medical device communication) Transport profile — Infrared wireless
 Part 30400: (Point-of-care medical device communication) Interface profile — Cabled Ethernet
 Part 90101: (Point-of-care medical device communication) Analytical instruments — Point-of-care test
 Part 91064: (Standard communication protocol) Computer-assisted electrocardiography
— Part 92001: (Medical waveform format) — Encoding rules
iv © IEEE 2013 – All rights reserved

Health Informatics—Personal health device communication

Part 10417: Device specialization—
Glucose meter
IEEE Engineering in Medicine and Biology Society

Sponsored by the
IEEE 11073™ Standards Committee

IEEE
IEEE Std 11073-10417™-2011
3 Park Avenue
(Revision of
New York, NY 10016-5997
IEEE Std 11073-10417-2009)
USA
27 January 2012
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TM
IEEE Std 11073-10417 -2011
(Revision of
IEEE Std 11073-10417-2009)
Health informatics—Personal health device communication
Part 10417: Device specialization—
Glucose meter
Sponsor
TM
IEEE 11073 Standards Committee
of the
IEEE Engineering in Medicine and Biology Society

Approved 7 December 2011
IEEE-SA Standards Board
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Abstract: Within the context of the ISO/IE EE 11073 fa mily of standards fo r device
communication, a normative definition of co mmunication between personal telehealth glucose
meter devices and compute engines (e.g., cell phones, personal computers, personal health
appliances, and set top boxes) is established by this standard in a manner that enables plug-and-
play interoperability. Appropriate portions of existing standards are leveraged, including ISO/IEEE
11073 terminology, information models, application profile standards, and transport standards.
The use of specific term codes, formats, and behaviors in telehealth environments restricting
optionality in base fram eworks in favor of interoperability ar e specified. A common core of
communication functionality for personal telehealth glucose meters is defined in this standard.

Keywords: glucose meter, IEEE 11073-10417, medical device communication, personal health
devices
The Institute of Electrical and Electronics Engineers, Inc.
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Introduction
This introduction is not part of IEEE Std 11073-10417-2011, Health informatics—Personal health device communication—Part
10417: Device specialization—Glucose meter.
ISO/IEEE 11073 standards enable communication between medical devices and external computer
a
systems. This document uses the optimized framework created in ISO/IEEE 11073-20601:2010 and
describes a specific, interoperable communication approach for glucose meters. These standards align with
and draw on the existing clinically focused standards to provide support for communication of data from
clinical or personal health devices.
Revision history for IEEE Std 11073-10417

IEEE Std 11073- Initial release of the standard.
10417-2009
IEEE Std 11073- The following changes were implemented in this revision:
10417-2011
a) In Table 6, the Supplemental-Type attribute was changed from Conditional to Optional.
b) In the fourth paragraph of 6.9.1, the first sentence was reworded to specify that the agent
init will be disabled when a PM-store is present.
c) In the second paragraph of 6.9.1, the use cases associated with agent-init versus
manager-init transmission of measurement data were clarified.
d) In Annex B, “Numeric class” to “Enumeration class” was corrected.
e) A new standard configuration was added, which affects the following:
1) New paragraph in 6.4.2.
2) Added a new Control Solution object separate from the Blood Glucose object
(6.6.7).
3) Removed MDC_CONC_GLU_CONTROL from the Blood Glucose object’s
Type attribute.
4) In 6.6.2, added +/- INFINITY as a way to indicate out-of-range sensor
measurements. Also added this to the new Control Solution object in 6.6.7.
f) In Table 13, the Semantic-Modality attribute was removed and the Supplemental-Types
attribute was added.
g) MDC_CONC_GLU_UNDETERMINED_PLASMA and
MDC_CONC_GLU_UNDETERMINED_WHOLEBLOOD were added for meters that
report plasma or whole blood glucose concentrations taken from an unknown sample
source. Also, Table 1 was modified to add the “undetermined” sample source. The new
OID was added to the Blood Glucose object extended configuration and the new
standard configuration (Table 7).
h) The MDC_CTXT_GLU_MEAL_BEDTIME nomenclature code was added to the
Context Meal enumeration object.
i) The Confirm-Timeout attribute was added, which was missing in Table 22.
j) Table 13 was corrected. The recommended Enum-Observed-Value attribute should be
Basic-Bit-Str instead of Simple-Bit-Str, as explained in the text following the table.
k) In E.5.1, the encoding of Measurement-Active-Period = 1 hour was corrected to be a
FLOAT type instead of a UINT-32.
l) In C.3, the description of Glucose | Context | Meal | BeforeMeal was corrected and lines
were added for Glucose | Context | Meal | Fasting and Glucose | Context | Meal |
Bedtime.
m) In 8.3.2 and 8.3.3, the protocol-version text was modified to clarify what must be done
when multiple protocol versions exist.

a
For information on references, see Clause 2.
iv
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n) In 8.2, the N limitation requirement was modified such that there is a limit for non-PM-
tx
store configurations but not for a PM-store configuration. The N value of 5120 for non-
tx
PM-store configurations is based on an event report that contains 25 measurements of
each of the 11 defined objects.
o) An additional use case description text to 5.1 was added.
p) Title, headers and footers, copyrights, formatting, references, and so on were updated
per IEEE Standards publishing guidelines.
q) In Table 7 for the Simple-Nu-Observed-Value and Compound-Simple-Nu-Observed-
Value, the qualifier to “C” was changed and the text in the Value column was expanded.
r) In 6.6.1, the first sentence of the last paragraph was replaced with “For standard
configurations the optional attributes are initially not present.”
s) Six occurrences of “manager device” to were changed to “manager”.

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Contents
1. Overview . 1
1.1 Scope . 1
1.2 Purpose . 1
1.3 Context . 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations . 3
3.1 Definitions . 3
3.2 Acronyms and abbreviations . 3
4. Introduction to ISO/IEEE 11073 personal health devices . 4
4.1 General . 4
4.2 Introduction to IEEE 11073-20601 modeling constructs . 4
5. Glucose meter device concepts and modalities . 5
5.1 General . 5
6. Glucose meter domain information model . 6
6.1 Overview . 6
6.2 Class extensions . 6
6.3 Object instance diagram . 7
6.4 Types of configuration . 8
6.5 Medical device system object . 9
6.6 Numeric objects . 12
6.7 Real-time sample array objects . 18
6.8 Enumeration objects . 18
6.9 PM-store objects . 22
6.10 Scanner objects . 26
6.11 Class extension objects . 26
6.12 Glucose meter information model extensibility rules . 26
7. Glucose meter service model . 26
7.1 General . 26
7.2 Object access services. 26
7.3 Object access event report services . 27
8. Glucose meter communication model . 29
8.1 Overview . 29
8.2 Communication characteristics . 29
8.3 Association procedure . 29
8.4 Configuring procedure . 31
8.5 Operating procedure . 33
8.6 Time synchronization . 34
YLL
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9. Test associations . 34
9.1 Behavior with standard configuration . 35
9.2 Behavior with extended configurations . 35
10. Conformance . 35
10.1 Applicability . 35
10.2 Conformance specification . 35
10.3 Levels of conformance . 36
10.4 Implementation conformance statements . 36
Annex A (informative) Bibliography . 41
Annex B (normative) Any additional ASN.1 definitions . 42
Annex C (normative) Allocation of identifiers . 43
Annex D (informative) Message sequence examples . 46
Annex E (informative) Protocol data unit examples . 48
Annex F (informative) IEEE list of participants . 58
YLLL
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ISO/IEEE 11073-10417:2013(E)
Health informatics—Personal health device communication
Part 10417: Device specialization—
Glucose meter
IMPORTANT NOTICE: This standard is not intended to ensure safety, security, health, or
environmental protection. Implementers of the standard are responsible for determining appropriate
safety, security, environmental, and health practices or regulatory requirements.
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1. Overview
1.1 Scope
Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard
establishes a normative definition of communication between personal telehealth glucose meter devices and
compute engines (e.g., cell phones, personal computers, personal health appliances, and set top boxes) in a
manner that enables plug-and-play interoperability. It leverages appropriate portions of existing standards,
including ISO/IEEE 11073 terminology, information models, application profile standards, and transport
standards. It specifies the use of specific term codes, formats, and behaviors in telehealth environments
restricting optionality in base frameworks in favor of interoperability. This standard defines a common core
of communication functionality for personal telehealth glucose meters.
1.2 Purpose
This standard addresses a need for an openly defined, independent standard for controlling information
exchange to and from personal health devices and compute engines (e.g., cell phones, personal computers,
personal health appliances, and set top boxes). Interoperability is the key to growing the potential market
for these devices and to enabling people to be better informed participants in the management of their
health.
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ISO/IEEE 11073-10417:2013(E)
IEEE Std 11073-10417-2011
Health informatics—Personal health device communication
Part 10417: Device specialization—Glucose meter

1.3 Context
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See IEEE Std 11073-20601a -2010 for an overview of the environment within which this standard is
written.
This standard defines the device specialization for the glucose meter, being a specific agent type, and it
provides a description of the device concepts, its capabilities, and its implementation according to this
standard.
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This standard is based on IEEE Std 11073-20601a -2010 and ISO/IEEE 11073-20601:2010, which in turn
draw information from both ISO/IEEE 11073-10201:2004 [B3] and ISO/IEEE 11073-20101:2004 [B4].
The medical device encoding rules (MDERs) used within this standard are fully described in
ISO/IEEE 11073-20601:2010.
This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B2]
and adds new nomenclature codes for the purposes of this standard. Among this standard,
ISO/IEEE 11073-20601:2010, and IEEE Std 11073-20601a-2010, all required nomenclature codes for
implementation are documented.
NOTE 1—IEEE Std 11073-20601a-2010 is an amendment to ISO/IEEE 11073-20601:2010. It contains new material
and corrections and does not copy the content of ISO/IEEE 11073-20601:2010. Throughout this standard, a reference
to IEEE Std 11073-20601a-2010 refers to the document that is obtained after applying this new material and
corrections to ISO/IEEE 11073-20601:2010.
NOTE 2—In this standard, ISO/IEEE 11073-104zz is used to refer to the collection of device specialization standards
that utilize IEEE Std 11073-20601a-2010, where zz can be any number from 01 to 99, inclusive.
2. Normative references
The following referenced documents are indispensable for the application of this document (i.e., they must
be understood and used, so that each referenced document is cited in text and its relationship to this
document is explained). For dated references, only the edition cited applies. For undated references, the
latest edition of the referenced document (including any amendments or corrigenda) applies.
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IEEE Std 11073-20601a -2010, Health informatics—Personal health device communication—Application
4,5
profile—Optimized Exchange Protocol—Amendment 1.
ISO/IEEE 11073-20601:2010, Health informatics—Personal health device communication—Application
profile—Optimized Exchange Protocol.

Information on references can be found in Clause 2.
The numbers in brackets correspond to those of the bibliography in Annex A.
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
The IEEE standards or products referred to in this clause are trademarks of the Institute of Electrical and Electronics Engineers, Inc.
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854-
4141, USA (http://standards.ieee.org/).
ISO/IEEE publications are available from the ISO Central Secretariat, 1, ch. de la Voie-Creuse, Case postale 56, CH-1211, Geneva
20, Switzerland (http://www.iso.ch/). ISO/IEEE publications are also available in the United States from the Institute of Electrical and
Electronics Engineers, 445 Hoes Lane, Piscatawa
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