EN ISO 11073-10407:2011
(Main)Health informatics - Personal health device communication - Part 10407: Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010)
Health informatics - Personal health device communication - Part 10407: Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010)
ISO/IEEE 11073-10407:2010 establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth blood pressure monitors.
ISO/IEEE 11073-10407:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10407: Gerätespezifikation - Blutdruckmonitor (ISO/IEEE 11073-10407:2010)
Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10407: Spécialisation des dispositifs - Moniteur de pression sanguine (ISO/IEEE 11073-10407:2010)
L'ISO/IEEE 11073-10407:2010 établit une définition normative de la communication entre des dispositifs de moniteurs de pression sanguine 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 moniteurs de pression sanguine personnels de télésanté.
L'ISO/IEEE 11073-10407:2010 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 - 10407. del: Specialne naprave - Kontrolna naprava za merjenje krvnega pritiska (ISO/IEEE 11073-10407:2010)
V okviru konteksta družine standardov za komunikacijo naprav ISO/IEEE 11073 ta standard vzpostavlja normativno definicijo komunikacije med osebnimi telemedicinskimi kontrolnimi napravami za merjenje krvnega pritiska in stroji za izračunavanje (npr. mobilnimi telefoni, osebnimi računalniki, osebnimi medicinskimi napravami, digitalnimi sprejemniki) na način, ki omogoča interoperabilnost Plug and Play (PnP). Uporablja primerne dele obstoječih standardov, vključno s terminologijo ISO/IEEE 11073, informacijskimi modeli, standardi za profile uporab in transportnimi standardi. Določa uporabo nekaterih kodnih izrazov, formatov in vedenj v telemedicinskih okoljih ter omejuje izbiro osnovnih ogrodij v korist interoperabilnosti. Ta standard določa skupno jedro komunikacijske funkcionalnosti za osebne telemedicinske kontrolne naprave za merjenje krvnega pritiska.
General Information
- Status
- Withdrawn
- Publication Date
- 15-Mar-2011
- Withdrawal Date
- 20-Jan-2026
- Technical Committee
- CEN/TC 251 - Medical informatics
- Drafting Committee
- CEN/TC 251/WG 2 - Terminology and knowledge representation
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 21-Dec-2022
- Completion Date
- 21-Jan-2026
Relations
- Effective Date
- 28-Dec-2022
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN ISO 11073-10407:2011 is a standard published by the European Committee for Standardization (CEN). Its full title is "Health informatics - Personal health device communication - Part 10407: Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010)". This standard covers: ISO/IEEE 11073-10407:2010 establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth blood pressure monitors. ISO/IEEE 11073-10407:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
ISO/IEEE 11073-10407:2010 establishes a normative definition of communication between personal telehealth blood pressure monitor devices and computer 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 behaviours in telehealth environments restricting optionality in base frameworks in favour of interoperability. This International Standard defines a common core of communication functionality for personal telehealth blood pressure monitors. ISO/IEEE 11073-10407:2010 addresses a need for an openly defined, independent standard for controlling information exchange to and from personal health devices and computer engines.
EN ISO 11073-10407:2011 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment; 35.240.80 - IT applications in health care technology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 11073-10407:2011 has the following relationships with other standards: It is inter standard links to EN ISO/IEEE 11073-10407:2022, EN ISO 18472:2006, EN ISO 17665-1:2006. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 11073-10407:2011 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2011
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Teil 10407: Gerätespezifikation - Blutdruckmonitor (ISO/IEEE 11073-10407:2010)
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Ta slovenski standard je istoveten z: EN ISO 11073-10407:2011
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 11073-10407
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2011
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 10407: Device specialization - Blood pressure monitor
(ISO/IEEE 11073-10407:2010)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 10407: Spécialisation des die persönliche Gesundheit - Teil 10407:
dispositifs - Moniteur de pression sanguine (ISO/IEEE Gerätespezifikation - Blutdruckmonitor (ISO/IEEE 11073-
11073-10407:2010) 10407:2010)
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 11073-10407:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
The text of ISO/IEEE 11073-10407:2010 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
11073-10407:2011 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 11073-10407:2010 has been approved by CEN as a EN ISO 11073-10407:2011 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-10407
First edition
2010-05-01
Health informatics — Personal health
device communication —
Part 10407:
Device specialization — Blood pressure
monitor
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 10407: Spécialisation des dispositifs — Moniteur de pression
sanguine
Reference number
ISO/IEEE 11073-10407:2010(E)
©
ISO 2010
©
IEEE 2010
ISO/IEEE 11073-10407:2010(E)
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© 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
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Published in Switzerland
ii © IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
Contents Page
Foreword. v
Introduction.vii
1. Overview . 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 1
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. Blood pressure monitor device concepts and modalities. 5
5.1 General. 5
5.2 Systolic and diastolic pressure . 5
5.3 Mean arterial pressure. 5
5.4 Pulse rate. 5
6. Blood pressure monitor domain information model. 6
6.1 Overview. 6
6.2 Class extensions . 6
6.3 Object instance diagram. 6
6.4 Types of configuration . 7
6.5 Medical device system object . 7
6.6 Numeric objects . 11
6.7 Real-time sample array objects . 13
6.8 Enumeration objects. 13
6.9 PM-store objects . 15
6.10 Scanner objects . 15
6.11 Class extension objects . 15
6.12 Blood pressure monitor information model extensibility rules. 15
7. Blood pressure monitor service model . 15
7.1 General. 15
7.2 Object access services. 15
7.3 Object access event report services. 16
© IEEE 2010 – All rights reserved iii
ISO/IEEE 11073-10407:2010(E)
8. Blood pressure monitor communication model. 17
8.1 Overview. 17
8.2 Communication characteristics . 17
8.3 Association procedure. 17
8.4 Configuring procedure . 19
8.5 Operating procedure. 21
8.6 Time synchronization. 21
9. Test associations. 21
9.1 General. 21
9.2 Behavior with standard configuration . 22
9.3 Behavior with extended configurations. 22
10. Conformance . 22
10.1 Applicability. 22
10.2 Conformance specification. 22
10.3 Levels of conformance. 23
10.4 Implementation conformance statements. 23
Annex A (informative) Bibliography. 28
Annex B (normative) Any additional ASN.1 definitions. 29
Annex C (normative) Allocation of identifiers . 30
Annex D (informative) Message sequence examples . 31
Annex E (informative) Protocol data unit examples. 33
iv © IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(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 11073-10407 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-10407-2008). 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
© IEEE 2010 – All rights reserved v
ISO/IEEE 11073-10407:2010(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
vi © IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
Introduction
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems.
a
This document uses the optimized framework created in IEEE Std 11073-20601 and describes a specific,
interoperable communication approach for blood pressure monitors. These standards align with and draw
on the existing clinically focused standards to provide support for communication of data from personal
health devices.
a
Information on references can be found in Clause 2.
© IEEE 2010 – All rights reserved vii
INTERNATIONAL STANDARD ISO/IEEE 11073-10407:2010(E)
Health informatics — Personal health device
communication —
Part 10407:
Device specialization — Blood pressure monitor
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 blood pressure monitor
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 blood pressure monitors.
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.
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 11073-10407, defines the device specialization for the blood pressure monitor,
being a specific agent type, and provides a description of the device concepts, its capabilities, and its
implementation according to this standard.
© IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
This standard is based on IEEE Std 11073-20601, which in turn draws information from both
ISO/IEEE 11073-10201:2004 [B5] and ISO/IEEE 11073-20101:2004 [B6]. The medical device encoding
rules (MDERs) 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 [B4]
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
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.
See Annex A for all informative material referenced by this standard.
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 Terms [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 blood pressure: The cyclic pressure (i.e., amount of force applied over a given area divided by the
size of this area) exerted by blood against the walls of blood vessels. Noninvasive blood pressure
measurement is typically performed at the brachial artery (arm) or radial artery (wrist). There are usually
two numbers reported for blood pressure, and with the home monitors, a third number is typically available.
The first, and higher, number is produced by the contraction of the heart (See: systolic pressure). The
second, lower number is produced by relaxation of the heart (See: diastolic pressure). The third number is
the mean arterial pressure.
3.1.3 class: In object-oriented modeling, a class describes the attributes, methods, and events that objects
instantiated from the class utilize.
3.1.4 compute engine: See: manager.
3.1.5 device: A term used to refer to a physical apparatus implementing either an agent or a manager role.
3.1.6 diastolic pressure: This is minimum pressure achieved during the cardiac cycle. It is typically the
second and the lower of the readings given as the blood pressure.
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,
USA (http://standards.ieee.org/).
© IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
3.1.7 handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances
within an agent.
3.1.8 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.
3.1.9 mean arterial pressure: value of the integral of one cycle of the blood pressure curve divided by the
period between successive heart beats.
3.1.10 obj-handle: See: handle.
3.1.11 object: In object-oriented modeling, a particular instantiation of a class. The instantiation realizes
attributes, methods, and events from the class.
3.1.12 personal health device: A device used in personal health applications.
3.1.13 personal telehealth device: See: personal health device.
3.1.14 pulse: The frequency of the cardiac cycle as reported by the blood pressure monitor.
3.1.15 pulse pressure: The systolic pressure minus the diastolic pressure.
3.1.16 systolic pressure: This maximum value of the arterial blood pressure as a result of the contraction
of the left ventricle. It is typically the first and the higher of the readings given as the blood pressure.
3.2 Acronyms and abbreviations
APDU application protocol data unit
ASN.1 Abstract Syntax Notation One
BPM beats per minute
DIM domain information model
EUI-64 extended unique identifier (64 bits)
ICS implementation conformance statement
MAP mean arterial pressure
MDC medical device communication
MDER medical device encoding rules
MDS medical device system
MOC managed object class
RT-SA real-time sample array
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 11073-20601 for a description of the guiding principles for this series of
ISO/IEEE 11073 Personal Health Device standards.
© IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
IEEE Std 11073-20601 supports the modeling and implementation of an extensive set of personal health
devices. This standard defines aspects of the blood pressure monitor device. It describes all aspects
necessary to implement the application layer services and data exchange protocol between an ISO/IEEE
11073 PHD blood pressure monitor agent and a manager. This standard defines a subset of the objects and
functionality contained in IEEE Std 11073-20601 and extends and adds definitions where appropriate. All
new definitions are given in Annex B in Abstract Syntax Notation One (ASN.1) [B7]. Nomenclature codes
referenced in this standard, which are not defined in IEEE Std 11073-20601, are normatively defined in
Annex C.
4.2 Introduction to IEEE 11073-20601 modeling constructs
4.2.1 General
The ISO/IEEE 11073 series of standards, and in particular the IEEE Std 11073-20601, is based on an
object-oriented systems management paradigm. The overall system model is divided into three principal
components: the domain information model (DIM), the service model, and the communication model. See
IEEE Std 11073-20601 for a detailed description of the modeling constructs.
4.2.2 Domain information model
The DIM is a hierarchical model that describes an agent as a set of objects. These objects and their
attributes represent the elements that control behavior and report on the status of the agent and data that an
agent can communicate to a manager. Communication between the agent and the manager is defined by the
application protocol in IEEE Std 11073-20601.
4.2.3 Service model
The service model defines the conceptual mechanisms for the data exchange services. Such services are
mapped to messages that are exchanged between the agent and the manager. Protocol messages within the
ISO/IEEE 11073 series of standards are defined in ASN.1. The messages defined in IEEE Std 11073-20601
can coexist with messages defined in other standard application profiles defined in the ISO/IEEE 11073
series of standards.
4.2.4 Communication model
In general, the communication model supports the topology of one or more agents communicating over
logical point-to-point connections to a single manager. For each logical point-to-point connection, the
dynamic system behavior is defined by a connection state machine as specified in IEEE Std 11073-20601.
4.2.5 Implementing the models
An agent implementing this standard shall implement all mandatory elements of the information, service,
and communication models as well as all conditional elements where the condition is met. The agent should
implement the recommended elements, and it may implement any combination of the optional elements. A
manager implementing this standard shall utilize at least one of the mandatory, conditional, recommended,
or optional elements. In this context, “utilize” means use the element as part of the primary function of the
manager device. For example, a manager whose primary function is to display data would need to display a
piece of data in the element in order to utilize it.
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ISO/IEEE 11073-10407:2010(E)
5. Blood pressure monitor device concepts and modalities
5.1 General
This clause presents the general concepts of blood pressure monitor devices. In the context of personal
health devices in this family of standards, a blood pressure monitor is a device that measures blood pressure
[i.e., systolic, diastolic, and mean arterial pressure (MAP)] and, optionally, pulse noninvasively. Blood
pressure monitor devices considered in this standard typically inflate a cuff to occlude an artery and then to
measure the reaction of the artery while the pressure is released with the results being converted into
systolic, diastolic, and MAP values. Optionally, pulse rate may be determined at the same time.
Blood pressure monitor devices may use a variety of techniques for measuring blood pressure and pulse
rate. One typical method is the oscillometric method where oscillations in cuff pressure are analyzed to
obtain blood pressure values. Another technique is the automated auscultatory method where the device
uses a microphone to detect Korotkoff sounds during cuff deflation. Auscultatory devices measure the
systolic and diastolic values and estimates the MAP.
In home monitors, the oscillometric method is typically used, allowing the measurement to be done
electronically. On the oscillometric method, small pressure changes (oscillations) occur in the cuff as a
result of blood pressure pulses during the inflation or deflation of the cuff and are detected. These
oscillations, which first increase and then decrease, are stored together with the corresponding cuff pressure
values in the automated sphygmomanometer. With these stored values, the systolic, diastolic, and mean
blood pressure values can be mathematically derived using an appropriate algorithm.
Blood pressure is historically most frequently measured using the units of millimeters of mercury (mmHg).
Kilopascals (kPa) may also be used. This standard supports both mmHg and kPa.
5.2 Systolic and diastolic pressure
The systolic and diastolic blood pressure measurements indicate the highest and lowest blood pressures
during the cardiac cycle. Normally, a single measurement is insufficient to provide the complete
information regarding the state of the heart and vascular system, and so both systolic and diastolic blood
pressure measurements are provided. According to this standard, both systolic and diastolic blood pressures
are always reported together.
5.3 Mean arterial pressure
Mean arterial pressure is reported in the same units as systolic and diastolic blood pressure. It is reported at
the same time as systolic and diastolic blood pressure. It is required for this standard.
5.4 Pulse rate
Pulse rate is measured in beats per minute (BPM). Reporting a pulse rate is supported by this standard, but
it is optional in some configurations.
© IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
6. Blood pressure monitor domain information model
6.1 Overview
This clause describes the domain information model of the blood pressure monitor.
6.2 Class extensions
In this standard, no class extensions are defined with respect to IEEE Std 11073-20601.
6.3 Object instance diagram
The object instance diagram of the blood pressure monitor domain information model, which is defined for
the purposes of this standard, is shown in Figure 1.
The objects of the DIM, as shown in Figure 1, are described in 6.4 to 6.12. This includes the medical device
system (MDS) object (see 6.5), the numeric objects (see 6.6), the real-time sample array (RT-SA) objects
(see 1.1), the enumeration objects (see 1.1), the PM-store objects (see 6.9), and the scanner objects (see
6.10). See 6.11 for rules for extending the blood pressure monitor information model beyond elements as
described in this standard. Each clause that describes an object of the blood pressure monitor contains the
following information:
⎯ The nomenclature code used to identify the class of the object. One example of where this code
is used is the configuration event, where the object class is reported for each object. This allows
the manager to determine whether the class of the object being specified is a numeric, real-time
sample array, enumeration, scanner, or PM-store class.
⎯ The attributes of the object. Each object has attributes that represent and convey information on
the physical device and its data sources. Each object has a Handle attribute that identifies the
object instance within an agent. Attribute values are accessed and modified using methods such
as GET and SET. Attribute types are defined using an ASN.1. The ASN.1 definitions for new
attribute types specific to this standard are in Annex B, and the ASN.1 definitions for existing
attribute types referenced in this standard are in IEEE Std 11073-20601.
⎯ The methods available on the object.
⎯ The potential events generated by the object. Data are sent to the manager using events.
⎯ The available services such as getting or setting attributes.
The attributes for each class are defined in tables that specify the name of the attribute, its value, and its
qualifier. The qualifiers mean M — Attribute is Mandatory, C — Attribute is Conditional and depends on
the condition stated in the Remark or Value column (if IEEE Std 11073-20601 is referenced, then it
contains the conditions), R — Attribute is Recommended, NR — Attribute is Not Recommended, and O —
Attribute is Optional. Mandatory attributes shall be implemented by an agent. Conditional attributes shall
be implemented if the condition applies and may be implemented otherwise. Recommended attributes
should be implemented by the agent. Not recommended attributes should not be implemented by the agent.
Optional attributes may be implemented on an agent.
The attributes can be either static, meaning that they shall remain unchanged after the configuration is
agreed upon, or dynamic, meaning that the attribute may change at some point after configuration.
© IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
PHD-Blood Pressure Monitor object instances
MDS
0.1
Compound Numeric Numeric
Systolic,
Pulse
Diastolic,
MAP
Figure 1 —Blood pressure monitor—domain information model
6.4 Types of configuration
6.4.1 General
As specified in IEEE Std 11073-20601, there are two styles of configuration available. Subclauses 6.4.2
and 6.4.3 briefly introduce standard and extended configurations.
6.4.2 Standard configuration
Standard configurations are defined in the IEEE 11073-104zz specializations (such as this standard) and are
assigned a well-known identifier (Dev-Configuration-Id). The usage of a standard configuration is
negotiated at association time between the agent and the manager. If the manager acknowledges that it
recognizes and wants to operate using the configuration, then the agent can begin sending measurements
immediately. If the manager does not recognize the configuration, the agent provides the configuration
prior to transmitting measurement information.
6.4.3 Extended configuration
In extended configurations, the agent’s configuration is not predefined in a standard. The agent determines
which objects, attributes, and values that it wants to use in a configuration and assigns a configuration
identifier. When the agent associates with a manager, it negotiates an acceptable configuration. Typically,
the manager does not recognize the agent’s configuration on the first connection, so the manager responds
that the agent needs to send the configuration information as a configuration event report. If, however, the
manager already understands the configuration, either because it was preloaded in some way or the agent
had previously associated with the manager, then the manager responds that the configuration is known and
no further configuration information needs to be sent.
6.5 Medical device system object
6.5.1 MDS object attributes
Table 1 summarizes the attributes of the blood pressure monitor MDS object. The nomenclature code to
identify the MDS class is MDC_MOC_VMS_MDS_SIMP.
© IEEE 2010 – All rights reserved
ISO/IEEE 11073-10407:2010(E)
Table 1 —MDS object attributes
Attribute name Value Qual.
Handle 0 M
System-Type Attribute not present. See IEEE Std 11073-20601. C
System-Type-Spec-List {MDC_DEV_SPEC_PROFILE_BP, 1}. M
System-Model {“Manufacturer”,”Model”}. M
System-Id extended unique identifier (64 bits) (EUI-64). M
Dev-Configuration-Id Standard config: 0x02BC (700) M
Extended configs: 0x4000–0x7FFF.
Attribute-Value-Map See IEEE Std 11073-20601. C
Production-Specification See IEEE Std 11073-20601. O
Mds-Time-Info See IEEE Std 11073-20601. C
Date-and-Time See IEEE Std 11073-20601. C
Relative-Time See IEEE Std 11073-20601. C
HiRes-Relative-Time See IEEE Std 11073-20601. C
Date-and-Time- See IEEE Std 11073-20601. C
Adjustment
Power-Status onBattery or onMains. R
Battery-Level See IEEE Std 11073-20601. R
Remaining-Battery- See IEEE Std 11073-20601. R
Time
Reg-Cert-Data-List See IEEE Std 11073-20601. O
Confirm-Timeout See IEEE Std 11073-20601. O
NOTE—See IEEE Std 11073-20601 for information on whether an attribute is static or dynamic.
In the response to a Get MDS Object command, only implemented attributes and their corresponding
values are returned.
See IEEE Std 11073-20601 for descriptive explanations of the individual attributes as well as for
information on attribute ID and attribute type.
The Dev-Configuration-Id attribute holds a locally unique 16-bit identifier that identifies the device
configuration. For a blood pressure monitor agent with extended configuration, this identifier is chosen in
the range of extended-config-start to extended-config-end (see IEEE Std 11073-20601) as shown in
Table 1.
The agent sends the Dev-Configuration-Id during the Associating state (see 8.3) to identify its configuration
for the duration of the association. If the manager already holds the configuration information relating to
the Dev-Configuration-Id, it recognizes the Dev-Configuration-Id. Then the Configuring state (see 8.4) is
skipped, and the agent and manager then enter the Operating state. If the manager does not recognize the
Dev-Configuration-Id, the agent and manager enter the Configuring state.
If an agent i
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