Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO 11073-10417:2014)

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.

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)

Dans le contexte de la famille de normes ISO/IEEE 11073 relatives à la communication entre des dispositifs, la présente norme établit une définition normative de la communication entre des dispositifs glucomètres personnels de télésanté et des moteurs informatiques (par exemple des téléphones cellulaires, des ordinateurs personnels, des équipements personnels de santé et des boîtiers décodeurs) d'une manière qui permet une interopérabilité du type prêt à l'emploi. Elle s'appuie sur les parties appropriées de normes existantes, y compris la terminologie, des modèles d'informations, des normes de profils d'applications et des normes de transport de l'ISO/IEEE 11073. Elle spécifie l'utilisation de codes, de formats et de comportements en termes spécifiques dans les environnements de télésanté, en limitant les choix à des cadres de travail de base en faveur de l'interopérabilité. L'ISO/IEEE 11073-10417:2014 définit un noyau commun de fonctionnalités de communication pour les glucomètres personnels de télésanté.

Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10417. del: Specialne naprave - Glukometer (ISO 11073-10417:2014)

Ta standard v okviru skupine standardov za komunikacijo naprav ISO/IEEE 11073 določa normativno opredelitev komunikacije med osebnimi telemedicinskimi glukometri in upravljalnimi napravami (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami in digitalnimi sprejemniki) na način, ki omogoča interoperabilnost s takojšnjim učinkom („vstavi in poženi“). Standard temelji na ustreznih delih obstoječih standardov, vključno s terminologijo iz standarda ISO/IEEE 11073, informacijskimi modeli, standardi za profile aplikacije in standardi za prevoz. Določa uporabo posebnih kod izrazov, formatov in vedenj v telemedicinskih okoljih, kjer v korist interoperabilnosti omejuje izbirnost osnovnih okvirov. Ta standard določa skupno jedro komunikacijske funkcionalnosti za osebne telemedicinske glukometre.

General Information

Status
Withdrawn
Publication Date
03-Jun-2014
Withdrawal Date
04-Sep-2017
Technical Committee
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
28-Jul-2017
Due Date
20-Aug-2017
Completion Date
05-Sep-2017

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SLOVENSKI STANDARD
SIST EN ISO 11073-10417:2014
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
SIST EN ISO 11073-10417:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-10417:2014

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SIST EN ISO 11073-10417:2014

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.

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SIST EN ISO 11073-10417:2014
EN ISO 11073-10417:2014 (E)
Contents Page
Foreword .3
2

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SIST EN ISO 11073-10417:2014
EN ISO 11073-10417:2014 (E)
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
EN ISO 11073-10417:2014 without any modification.


3

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SIST EN ISO 11073-10417:2014

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SIST EN ISO 11073-10417:2014

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

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SIST EN ISO 11073-10417:2014
ISO/IEEE 11073-10417:2013(E)
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ii © IEEE 2013 – All rights reserved

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SIST EN ISO 11073-10417:2014
ISO/IEEE 11073-10417:2013(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
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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
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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 matter
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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

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SIST EN ISO 11073-10417:2014
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

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SIST EN ISO 11073-10417:2014


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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SIST EN ISO 11073-10417:2014
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SIST EN ISO 11073-10417:2014
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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SIST EN ISO 11073-10417:2014
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






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SIST EN ISO 11073-10417:2014
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SIST EN ISO 11073-10417:2014
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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SIST EN ISO 11073-10417:2014
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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SIST EN ISO 11073-10417:2014
Interpretations
Current interpretations can be accessed at the following URL:
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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 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
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