SIST EN ISO 11073-10417:2011
(Main)Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2010)
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter (ISO/IEEE 11073-10417:2010)
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-andplay 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 - Zuckermessgerät (ISO/IEEE 11073-10417:2010)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10417: Spécialisation des dispositifs - Glucomètre (ISO/IEEE 11073-10417:2010)
L'ISO/IEEE 11073-10417:2010 établit une définition normative de la communication entre des dispositifs de 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. Elle définit un noyau commun de fonctionnalités de communication pour les glucomètres personnels de télésanté.
L'ISO/IEEE 11073-10417:2010 répond au besoin d'une norme indépendante définie de manière ouverte portant sur la commande de l'échange d'informations entre des dispositifs personnels de santé et des moteurs informatiques.
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10417. del: Specialne naprave - Glukometer (ISO/IEEE 11073-10417:2010)
V okviru konteksta družine standardov za komunikacijo naprav ISO/IEEE 11073 ta standard vzpostavlja normativno definicijo komunikacije med osebnimi telemedicinskimi glukometri in stroji za izračunavanje (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča Plug and Play (PnP) interoperabilnost. Koristi primerne dele obstoječih standardov, vključno s terminologijo ISO/IEEE 11073, informacijskimi modeli, standardi za profile uporab in transportnimi standardi. Določa uporabo določenih kod izrazov, formatov in vedenj v telemedicinskih okoljih ter omejuje opcionalnost osnovnih ogrodij v korist interoperabilnosti. Ta standard določa skupno jedro komunikacijske funkcionalnosti za osebne telemedicinske glukometre.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11073-10417:2011
01-maj-2011
Zdravstvena informatika - Komunikacija osebnih medicinskih naprav - 10417. del:
Specialne naprave - Glukometer (ISO/IEEE 11073-10417:2010)
Health informatics - Personal health device communication - Part 10417: Device
specialization - Glucose meter (ISO/IEEE 11073-10417:2010)
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit -
Teil 10417: Gerätespezifikation - Zuckermessgerät (ISO/IEEE 11073-10417:2010)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie
10417: Spécialisation des dispositifs - Glucomètre (ISO/IEEE 11073-10417:2010)
Ta slovenski standard je istoveten z: EN ISO 11073-10417:2011
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 11073-10417:2011 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11073-10417:2011
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SIST EN ISO 11073-10417:2011
EUROPEAN STANDARD
EN ISO 11073-10417
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2011
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 10417: Device specialization - Glucose meter (ISO/IEEE
11073-10417:2010)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 10417: Spécialisation des die persönliche Gesundheit - Teil 10417:
dispositifs - Glucomètre (ISO/IEEE 11073-10417:2010) Gerätespezifikation - Zuckermessgerät (ISO/IEEE 11073-
10417:2010)
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 11073-10417:2011: E
worldwide for CEN national Members.
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SIST EN ISO 11073-10417:2011
EN ISO 11073-10417:2011 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11073-10417:2011
EN ISO 11073-10417:2011 (E)
Foreword
The text of ISO/IEEE 11073-10417:2010 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
11073-10417:2011 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 11073-10417:2010 has been approved by CEN as a EN ISO 11073-10417:2011 without
any modification.
3
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SIST EN ISO 11073-10417:2011
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SIST EN ISO 11073-10417:2011
INTERNATIONAL ISO/IEEE
STANDARD 11073-10417
First edition
2010-05-01
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 11073-10417:2010(E)
©
ISO 2010
©
IEEE 2010
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(E)
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© ISO 2010 – All rights reserved
ii © IEEE 2010 – All rights reserved
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(E)
Contents Page
Foreword. v
Introduction.vii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 2
3. Definitions, acronyms, and abbreviations. 2
3.1 Definitions. 2
3.2 Acronyms and abbreviations. 3
4. Introduction to ISO/IEEE 11073 personal health devices. 3
4.1 General. 3
4.2 Introduction to IEEE 11073-20601 modeling constructs. 4
5. Glucose meter device concepts and modalities. 4
5.1 General. 4
6. Glucose meter domain information model. 5
6.1 Overview. 5
6.2 Class extensions . 6
6.3 Object instance diagram. 6
6.4 Types of configuration . 7
6.5 Medical device system object . 8
6.6 Numeric objects . 11
6.7 Real-time sample array objects . 16
6.8 Enumeration objects. 16
6.9 PM-store objects . 21
6.10 Scanner objects . 24
6.11 Class extension objects . 24
6.12 Glucose meter information model extensibility rules . 24
7. Glucose meter service model . 24
7.1 General. 24
7.2 Object access services. 25
7.3 Object access event report services. 25
© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved iii
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(E)
8. Glucose meter communication model. 27
8.1 Overview. 27
8.2 Communication characteristics . 27
8.3 Association procedure. 27
8.4 Configuring procedure . 29
8.5 Operating procedure. 30
8.6 Time synchronization. 31
9. Test associations . 31
9.1 Behavior with standard configuration . 31
9.2 Behavior with extended configurations. 32
10. Conformance. 32
10.1 Applicability. 32
10.2 Conformance specification. 32
10.3 Levels of conformance. 32
10.4 Implementation conformance statements. 33
Annex A (informative) Bibliography. 38
Annex B (normative) Any additional ASN.1 definitions. 39
Annex C (normative) Allocation of identifiers . 40
C.1 General . 40
C.2 Definitions of terms and codes . 40
C.3 Systematic derivations of terms and codes. 41
Annex D (informative) Message sequence examples . 43
Annex E (informative) Protocol data unit examples. 45
E.1 General . 45
E.2 Association information exchange. 45
E.3 Configuration information exchange . 48
E.4 GET MDS attributes service. 51
E.5 Data reporting. 52
E.6 Disassociation. 53
© ISO 2010 – All rights reserved
iv © IEEE 2010 – All rights reserved
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(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 11073-10417 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-10417-2008). 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 rights reserved
© IEEE 2010 – All rights reserved v
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(E)
— Part 10407: Device specialization — Blood pressure monitor
— Part 10408: (Point-of-care medical device communication) Device specialization —
Thermometer
— Part 10415: (Point-of-care medical device communication) Device specialization — Weighing
scale
— Part 10417: Device specialization — Glucose meter
— Part 10471: (Point-of-care medical device communication) Device specialization —
Independant living activity hub
— Part 20101: (Point-of-care medical device communication) Application profiles — Base
standard
— Part 20601: (Point-of-care medical device communication) 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
© ISO 2010 – All rights reserved
vi © IEEE 2010 – All rights reserved
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(E)
Introduction
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. This
a
document uses the optimized framework created in IEEE Std 11073-20601 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.
a
For information on references, see Clause 2.
© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved vii
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SIST EN ISO 11073-10417:2011
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SIST EN ISO 11073-10417:2011
INTERNATIONAL STANDARD ISO/IEEE 11073-10417:2010(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 in all circumstances. Implementers of the standard are responsible for
determining appropriate safety, security, environmental, and health practices or regulatory
requirements.
This IEEE document is made available for use subject to important notices and legal disclaimers. These
notices and disclaimers appear in all publications containing this document and may be found under the
heading “Important Notice” or “Important Notices and Disclaimers Concerning IEEE Documents.”
They can also be obtained on request from IEEE or viewed at http://standards.ieee.org/IPR/disclaimers.html.
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.
© ISO 2010 – All rights reserved
1
© IEEE 2010 – All rights reserved
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(E)
1.3 Context
TM
See IEEE Std 11073-20601 for an overview of the environment within which this standard is written.
This document, IEEE Std 11073-10417, 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.
This standard is based on IEEE Std 11073-20601, which in turn draws information from both
1
ISO/IEEE 11073-10201:2004 [B4] and ISO/IEEE 11073-20101:2004 [B3]. The medical device encoding
rules (MDER) used within this standard are fully described in IEEE Std 11073-20601.
This standard reproduces relevant portions of the nomenclature found in ISO/IEEE 11073-10101:2004 [B3]
and adds new nomenclature codes for the purposes of this standard. Between this standard and
IEEE Std 11073-20601, all required nomenclature codes for implementation are documented.
NOTE—In this standard, IEEE Std 11073-104zz is used to refer to the collection of device specialization standards that
2
utilize IEEE Std 11073-20601, 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.
TM
IEEE Std 11073-20601 -2008, Health informatics—Personal health device communication—Part 20601:
3,4
Application profile—Optimized Exchange Protocol.
3. Definitions, acronyms, and abbreviations
3.1 Definitions
For the purposes of this standard, the following terms and definitions apply. The Authoritative Dictionary
of IEEE Standards [B2] should be referenced for terms not defined in this clause.
3.1.1 agent: A node that collects and transmits personal health data to an associated manager.
3.1.2 class: In object-oriented modeling, a class describes the attributes, methods, and events that objects
instantiated from the class utilize.
3.1.3 compute engine: See: manager.
3.1.4 device: A term used to refer to a physical apparatus implementing either an agent or manager role.
3.1.5 glucose meter: A medical device for determining the approximate concentration of glucose in the
blood.
1
The numbers in brackets correspond to those of the bibliography in Annex A.
2
Notes in text, tables, and figures are given for information only and do not contain requirements needed to implement the standard.
3
The IEEE standards or products referred to in this clause are trademarks of the Institute of Electrical and Electronics Engineers, Inc.
4
IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
© ISO 2010 – All rights reserved
2
© IEEE 2010 – All rights reserved
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SIST EN ISO 11073-10417:2011
ISO/IEEE 11073-10417:2010(E)
3.1.6 handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances
within an agent.
3.1.7 manager: A node receiving data from one or more agent systems. Some examples of managers
include a cellular phone, health appliance, set top box, or a computer system.
3.1.8 obj-handle: See: handle.
3.1.9 object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
3.1.10 personal health device: A device used in personal health applications.
3.1.11 personal telehealth device: See: personal health device.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
AST alternative site testing
DIM domain information model
EUI-64 extended unique identifier (64 bits)
HbA1c hemoglobin bound to glucose (the A1c form)
HCP health care professional
ICS implementation conformance statements
ISF interstitial fluid
MDC medical device communication
MDER medical device encoding rules
MDS medical device system
MOC managed object class
OID object identifier
PDU protocol data unit
PHD personal health device
VMO virtual medical object
VMS virtual medical system
4. Introduction to ISO/IEEE 11073 personal health devices
4.1 General
This standard and the remainder of the series of ISO/IEEE 11073 personal health device (PHD) standards
fit in the larger context of the ISO/IEEE 11073 series of standards. The full suite of standards enables
agents to interconnect and interoperate with managers and with computerized health-care information
systems. See IEEE Std 11073
...
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