EN ISO 11073-20601:2011

SLOVENSKI STANDARD
01-maj-2011
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Ta slovenski standard je istoveten z: EN ISO 11073-20601:2011
ICS:
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 11073-20601
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2011
ICS 35.240.80
English Version
Health informatics - Personal health device communication -
Part 20601: Application profile - Optimized exchange protocol
(ISO/IEEE 11073-20601:2010)
Informatique de santé - Communication entre dispositifs de Medizinische Informatik - Kommunikation von Geräten für
santé personnels - Partie 20601: Profil d'application - die persönliche Gesundheit - Teil 20601: Anwendungsprofil
Protocole d'échange optimisé (ISO/IEEE 11073- - Optimiertes Datenübertragungsprotokoll (ISO/IEEE
20601:2010) 11073-20601:2010)
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 11073-20601:2011: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
The text of ISO/IEEE 11073-20601:2010 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
11073-20601:2011 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 11073-20601:2010 has been approved by CEN as a EN ISO 11073-20601:2011 without
any modification.
INTERNATIONAL ISO/IEEE
STANDARD 11073-20601
First edition
2010-05-01
Health informatics — Personal health
device communication —
Part 20601:
Application profile — Optimized
exchange protocol
Informatique de santé — Communication entre dispositifs de santé
personnels —
Partie 20601: Profil d'application — Protocole d'échange optimisé

Reference number
ISO/IEEE 11073-20601:2010(E)
©
ISO 2010
©
IEEE 2010
ISO/IEEE 11073-20601:2010(E)
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Published in Switzerland
ii © IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(E)
Contents Page
Foreword. vi
Introduction. viii
1. Overview. 1
1.1 Scope. 1
1.2 Purpose. 1
1.3 Context. 2
2. Normative references . 5
3. Definitions, acronyms, and abbreviations. 5
3.1 Definitions. 5
3.2 Acronyms and abbreviations. 5
4. Guiding principles. 6
5. Introduction to IEEE 11073 personal health devices . 7
5.1 General. 7
5.2 Domain information model (DIM). 8
5.3 Service model. 8
5.4 Communication model. 8
6. Personal health device DIM. 8
6.1 General. 8
6.2 Nomenclature usage. 9
6.3 Personal health object class definitions. 10
6.3.1 General . 10
6.3.2 MDS class . 12
6.3.3 Metric class. 18
6.3.4 Numeric class . 23
6.3.5 RT-SA class. 26
6.3.6 Enumeration class. 27
6.3.7 PM-store class . 30
6.3.8 PM-segment class. 34
6.3.9 Scanner classes . 37
6.4 Information model extensibility rules . 45
7. Personal health device service model . 45
7.1 General. 45
7.2 Association service . 46
7.3 Object access services. 46
7.4 Specific application of object access EVENT REPORT services for personal health devices . 47
7.4.1 General . 47
7.4.2 Confirmed and unconfirmed event reports. 47
© IEEE 2010 – All rights reserved iii

ISO/IEEE 11073-20601:2010(E)
7.4.3 Configuration event report . 47
7.4.4 Agent- and manager-initiated measurement data transmission . 49
7.4.5 Variable, fixed, and grouped format event reports . 50
7.4.6 Single-person and multiple-person event reports . 50
7.4.7 Temporarily stored measurements. 51
8. Communication model. 52
8.1 General. 52
8.2 System context . 52
8.3 Communications characteristics. 53
8.3.1 General . 53
8.3.2 Common communications characteristics . 55
8.3.3 Reliable communications characteristics. 55
8.3.4 Best-effort communications characteristics. 56
8.4 State machines. 56
8.4.1 Agent state machine . 56
8.4.2 Manager state machine . 59
8.4.3 Timeout variables . 60
8.5 Connected procedure. 61
8.5.1 General . 61
8.5.2 Entry conditions . 61
8.5.3 Normal procedures . 61
8.5.4 Exit conditions. 61
8.5.5 Error conditions. 62
8.6 Unassociated procedure . 62
8.6.1 General . 62
8.6.2 Entry conditions . 62
8.6.3 Normal procedures . 62
8.6.4 Exit conditions. 62
8.6.5 Error conditions. 62
8.7 Associating procedure. 63
8.7.1 General . 63
8.7.2 Entry conditions . 63
8.7.3 Normal procedures . 63
8.7.4 Exit conditions. 67
8.7.5 Error conditions. 67
8.7.6 Test association . 67
8.8 Configuring procedure . 69
8.8.1 General . 69
8.8.2 Entry conditions . 69
8.8.3 Normal procedures . 69
8.8.4 Exit conditions. 71
8.8.5 Error conditions. 71
8.9 Operating procedure. 72
8.9.1 General . 72
8.9.2 Entry conditions . 72
8.9.3 Normal procedures . 72
8.9.4 Exit conditions. 83
8.9.5 Error conditions. 83
8.10 Disassociating procedure . 85
8.10.1 General . 85
8.10.2 Entry conditions . 85
8.10.3 Normal procedures . 85
8.10.4 Exit conditions. 85
8.10.5 Error conditions. 86
8.11 Message encoding. 86
8.12 Time coordination . 86
iv © IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(E)
8.12.1 General . 86
8.12.2 Absolute time . 86
8.12.3 Relative time. 88
8.12.4 High-resolution relative time. 89
9. Conformance model. 89
9.1 Applicability . 89
9.2 Conformance specification. 90
9.3 Implementation conformance statements (ICSs) . 90
9.4 General conformance . 90
9.4.1 General ICS . 91
9.4.2 Minimum requirements ICS . 92
9.4.3 Service support ICS. 93
9.5 Device additions/extensions ICS. 94
9.5.1 General additions/extensions ICS. 94
9.5.2 Personal health device DIM object and class (POC) ICS. 95
9.5.3 POC attribute ICS. 95
9.5.4 POC behavior ICS . 96
9.5.5 POC notification ICS. 96
9.5.6 POC nomenclature ICS . 97
Annex A (normative) ASN.1 definitions . 98
Annex B (informative) Scale and range specification example . 130
Annex C (informative) The PM-store concept. 132
Annex D (informative) Transport profile types . 137
Annex E (normative) State tables . 140
Annex F (normative) Medical device encoding rules (MDER) . 151
Annex G (informative) Encoded data type definitions . 163
Annex H (informative) Examples. 182
Annex I (normative) Nomenclature codes . 190
Annex J (informative) Derivation and modification history. 194
Annex K (informative) Bibliography. 197

© IEEE 2010 – All rights reserved v

ISO/IEEE 11073-20601:2010(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 11073-20601 was prepared by the 11073 Committee of the Engineering in Medicine
and Biology Society of the IEEE (as IEEE Std 11073-20601-2008). 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
vi © IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(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
© IEEE 2010 – All rights reserved vii

ISO/IEEE 11073-20601:2010(E)
Introduction
ISO and IEEE 11073 standards enable communication between medical devices and external computer
systems. This standard and corresponding IEEE 11073-104zz standards address a need for a simplified and
optimized communication approach for personal health devices, which may or may not be regulated
devices. These standards align with, and draw upon, the existing clinically focused standards to provide
easy management of data from either a clinical or personal health device.
This document addresses a need for an openly defined, independent standard for converting the collected
information into an interoperable transmission format so the information can be exchanged between agents
and managers.
Other closely related standards include the following:
a
⎯ ISO/IEEE P11073-00103 [B8] provides an overview of the personal health space and defines the
underlying use cases and usage models.
⎯ ISO/IEEE 11073-10101 [B12] documents the nomenclature terms that can be used.
⎯ ISO/IEEE 11073-10201:2004 [B13] documents the extensive domain information model (DIM)
leveraged by this standard.
⎯ ISO/IEEE 11073-104zz standards define specific device specializations. For example, ISO/IEEE
P11073-10404 [B9] defines how interoperable pulse oximeters work.
⎯ ISO/IEEE 11073-20101:2004 [B14] defines the medical device encoding rules (MDER) used in this
standard.
a
The numbers in brackets correspond to the numbers of the bibliography in Annex K.
viii © IEEE 2010 – All rights reserved

INTERNATIONAL STANDARD ISO/IEEE 11073-20601:2010(E)

Health informatics — Personal health device
communication —
Part 20601:
Application profile — Optimized exchange protocol
IMPORTANT NOTICE: This standard is not intended to assure 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
defines a common framework for making an abstract model of personal health data available in transport-
independent transfer syntax required to establish logical connections between systems and to provide
presentation capabilities and services needed to perform communication tasks. The protocol is optimized to
personal health usage requirements and leverages commonly used methods and tools wherever possible.
1.2 Purpose
This document addresses a need for an openly defined, independent standard for converting the information
profile into an interoperable transmission format so the information can be exchanged to and from personal
telehealth devices and compute engines (e.g., cell phones, personal computers, personal health appliances,
and set top boxes).
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(E)
1.3 Context
Figure 1 shows categories and typical devices supporting the personal health space. Agents (e.g., blood
pressure monitors, weighing scales, and pedometers) collect information about a person (or persons) and
transfer the information to a manager (e.g., cell phone, health appliance, or personal computer) for
collection, display, and possible later transmission. The manager may also forward the data to remote
support services for further analysis. The information is available from a range of domains including
disease management, health and fitness, or aging independently applications.
The communication path between agent and manager is assumed to be a logical point-to-point connection.
Generally, an agent communicates with a single manager at any point in time. A manager may
communicate with multiple agents simultaneously using separate point-to-point connections.
The overlay shows the focus area of the IEEE 11073™ Personal Health Devices Working Group. The
primary concentration is the interface and data exchange between the agents and manager. However, this
interface cannot be created in isolation by ignoring the remainder of the solution space. Remaining
cognizant of the entire system helps to ensure that data can reasonably move from the agents all the way to
the remote support services when necessary. This path may include converting the data format, exchange
protocols, and transport protocols across different interfaces. Much of the standardization effort is outside
of the scope of the Personal Health Devices Working Group; however, aligning all standardization efforts
allows data to flow seamlessly through the overall set of systems.

Figure 1 —Overall context of work

Figure 2 shows a hierarchical view of the architecture of an agent or manager superimposed with a view of
the related standards. The application layers are, for the most part, not specific to any particular transport.
Where necessary, this standard identifies assumptions that require direct support by a transport or a “shim”
layer above the transport. This approach allows support for various transports. The definition of the
transports is outside the scope of this standard and the working group.
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(E)
Above the transport layer is the Optimized Exchange Protocol (described in this standard). This protocol
consists of two aspects: the application layer services and the definition of the data exchange protocol
between agents and managers. The application layer services provide the protocol for connection
management and reliable transfer of actions and data between agent and manager. The data exchange
protocol defines the commands, agent configuration information, data format, and overall protocol. The
Optimized Exchange Protocol provides the basis to support any type of agent. For a specific device type,
the reader is directed to the device specialization for that agent to understand the capabilities of the device
and its implementation according to this standard. The device specialization indicates which aspects of this
standard to comprehend and where further information to implement the device is found.
Above the exchange protocol are device specializations that describe specific details relative to the
particular agent (e.g., blood pressure monitor, weighing scale, or pedometer). The specializations describe
the details of how these agents work and act as a detailed description for creating a specific type of agent.
Additionally, they provide reference to a related standard for further details. The standard numbers reserved
for device specializations range from IEEE Std 11073-10401 through IEEE Std 11073-10499, inclusive.
When the collection of standards is being referenced, the term IEEE 11073-104zz is used where zz could be
any number in the range from 01 to 99, inclusive.
The ISO/IEEE P11073-00103 [B8] technical report describes the overall personal health space with further
definition of the underlying use cases and usage models.

Figure 2 —Document map
The personal health device specializations are not being created independently of all other standards. There
are a number of existing standards generated for clinical environments upon which these standards draw.
Figure 3 shows the relationship to the remainder of the IEEE 11073 documents. There are two types of
relationships:
The numbers in brackets correspond to the numbers of the bibliography in Annex K.
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(E)
⎯ Drawing ideas and/or content from the other documents (dashed lines)
⎯ Leveraging information from the other document and introducing new content into that document to
support this standard (solid lines)

This standard imports information from ISO/IEEE 11073-10201:2004 [B13] and ISO/IEEE 11073-
20101:2004 [B14] as normative annexes. If there is a discrepancy between these standards, this standard
takes priority. Because of the reuse of constructs from these standards, some of the names appear to be
more clinically focused [e.g., medical device system (MDS) instead of personal health device system];
however, to maintain consistency, the traditional names have been preserved.
This standard replicates relevant portions of ISO/IEEE 11073-10101 [B12] and incorporates new
nomenclature codes.
Figure 3 —Relationship to other IEEE 11073 documents
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(E)
2. Normative references
The following referenced documents are indispensable for the application of this standard (i.e., they must
be understood and used; therefore, each referenced document is cited in the text and its relationship to this
standard 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 802 -2001, IEEE Standard for Local and Metropolitan Area Networks: Overview and
Architecture.
ITU-T Rec. X.667 (Sept. 2004), Information technology – Open Systems Interconnection – Procedures for
the operation of OSI Registration Authorities: Generation and registration of universally unique identifiers
(UUIDs) and their use as ASN.1 object identifier components.
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 [B6] 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 compute engine: See: manager.
3.1.3 confirmed: An application-level, completion notification service mechanism. For EVENT REPORT
services (i.e., the data plane), confirmation allows the agent to know when the manager has “accepted
responsibility” for a piece of data so that the agent can delete that data. For the ACTION, GET, and SET
services (i.e., the control plane), confirmation allows the manager to know when the agent has “completed”
the requested transaction.
3.1.4 device: A physical device implementing either an agent or manager role.
3.1.5 handle: An unsigned 16-bit number that is locally unique and identifies one of the object instances
within an agent.
3.1.6 manager: A node receiving data from one or more agent systems. Examples of managers include a
cellular phone, health appliance, set top box, or computer system.
3.1.7 personal health device: A device used in personal health applications.
3.1.8 personal telehealth device: See: personal health device.
3.2 Acronyms and abbreviations
ASCII American Standard Code for Information Interchange
ASN.1 Abstract Syntax Notation One
APDU application protocol data unit

IEEE publications are available from the Institute of Electrical and Electronics Engineers, 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
ITU-T publications are available from the International Telecommunications Union, Place des Nations, CH-1211, Geneva 20,
Switzerland/Suisse (http://www.itu.int/).
Note that throughout this standard the term ASCII is used to mean the character set as defined in ISO/IEC 646 (1991) [B7].
© IEEE 2010 – All rights reserved

ISO/IEEE 11073-20601:2010(E)
AVA attribute value assertion
BER binary encoding rules
DIM domain information model
EUI-64 extended unique identifier (64 bits)
GMDN Global Medical Device Nomenclature
ICS implementation conformance statement
ID identifier
LSB least significant bit
MDER medical device encoding rules
MDNF medical device numeric format
MDS medical device system
MOC medical object class
MSB most significant bit
NaN not a number
NBO network byte order
NRes not at this resolution
NTP Network Time Protocol
OID object identifier
OUI organizationally unique identifier
PDU protocol data unit
PER packed encoding rules
POC personal health device domain information model object and class
RC retry count: association procedure
assoc
RTC real-time clock
RT-SA real-time sample array
SNTP Simple Network Time Protocol
TCP Transmission Control Protocol
TO timeout: association procedure
assoc
TO timeout: confirmed action service
ca
TO timeout: confirmed event report service for the MDS object
cer-mds
TO timeout: confirmed event report service for the PM-store object
cer-pms
TO timeout:
...