Health informatics - Personal health device communication - Part 10407: Device specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010)

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 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.

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
Published
Publication Date
14-Apr-2011
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
28-Mar-2011
Due Date
02-Jun-2011
Completion Date
15-Apr-2011

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SLOVENSKI STANDARD
SIST EN ISO 11073-10407:2011
01-maj-2011
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Health informatics - Personal health device communication - Part 10407: Device
specialization - Blood pressure monitor (ISO/IEEE 11073-10407:2010)

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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
SIST EN ISO 11073-10407:2011 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11073-10407:2011
---------------------- Page: 2 ----------------------
SIST EN ISO 11073-10407:2011
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 11073-10407:2011
EN ISO 11073-10407:2011 (E)
Contents Page

Foreword ..............................................................................................................................................................3

---------------------- Page: 4 ----------------------
SIST EN ISO 11073-10407:2011
EN ISO 11073-10407:2011 (E)
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.
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SIST EN ISO 11073-10407:2011
---------------------- Page: 6 ----------------------
SIST EN ISO 11073-10407:2011
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
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SIST EN ISO 11073-10407:2011
ISO/IEEE 11073-10407:2010(E)
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© ISO 2010
© IEEE 2010

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective

address below.
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Published in Switzerland
© ISO 2010 – All rights reserved
ii © IEEE 2010 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11073-10407:2011
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

© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 11073-10407:2011
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

© ISO 2010 – All rights reserved
iv © IEEE 2010 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 11073-10407:2011
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
© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST EN ISO 11073-10407:2011
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
© ISO 2010 – All rights reserved
vi © IEEE 2010 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 11073-10407:2011
ISO/IEEE 11073-10407:2010(E)
Introduction

ISO/IEEE 11073 standards enable communication between medical devices and external computer systems.

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.
Information on references can be found in Clause 2.
© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved vii
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SIST EN ISO 11073-10407:2011
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SIST EN ISO 11073-10407:2011
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

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.
© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved
---------------------- Page: 15 ----------------------
SIST EN ISO 11073-10407:2011
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.

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/).
© ISO 2010 – All rights reserved
© IEEE 2010 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 11073-10407:2011
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 d
...

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