SIST EN ISO 11073-20101:2005
(Main)Health informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004)
Health informatics - Point-of-care medical device communication - Part 20101: Application profiles - Base standard (ISO/IEEE 11073-20101:2004)
ISO/IEEE 11073-20101:2004 provides the upper layer [i.e., the International Organization for Standardization's (ISO's) open systems interconnection (OSI) application, presentation layer, and session layer] services and protocols for information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC).
ISO/IEEE 11073-20101:2004 is the base standard of the ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the Committee for European Normalization (CEN) and ISO.
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 20101: Profils d'applications - Norme de base (ISO/IEEE 11073-20101:2004)
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe – 20101. del: Profili aplikacije – Temeljni standard (ISO/IEEE 11073-20101:2004)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2005
Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe –
20101. del: Profili aplikacije – Temeljni standard (ISO/IEEE 11073-20101:2004)
Health informatics - Point-of-care medical device communication - Part 20101:
Application profiles - Base standard (ISO/IEEE 11073-20101:2004)
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 20101: Profils d'applications - Norme de base (ISO/IEEE 11073-20101:2004)
Ta slovenski standard je istoveten z: EN ISO 11073-20101:2005
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 11073-20101
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2005
ICS 35.240.80
English Version
Health informatics - Point-of-care medical device communication
- Part 20101: Application profiles - Base standard (ISO/IEEE
11073-20101:2004)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation patientennaher
médicaux sur le site des soins - Partie 20101: Profils medizinischer Geräte - Teil 20101: Anwendungsprofil -
d'applications - Norme de base (ISO/IEEE 11073- Basisnorm
20101:2004)
This European Standard was approved by CEN on 16 August 2005.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11073-20101:2005: E
worldwide for CEN national Members.
Foreword
The text of ISO/IEEE 11073-20101:2004 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 11073-20101:2005 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 February 2006, and conflicting national
standards shall be withdrawn at the latest by February 2006.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-20101:2004 has been approved by CEN as EN ISO 11073-
20101:2005 without any modifications.
INTERNATIONAL
ISO/IEEE
STANDARD
11073-20101
First edition
2004-12-15
Health informatics — Point-of-care
medical device communication —
Part 20101:
Application profiles — Base standard
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 20101: Profils d'applications — Norme de base
Reference number
ISO/IEEE 11073-20101:2004(E)
© ISO/IEEE 2004
ISO/IEEE 11073-20101:2004(E)
Health informatics — Point-of-care medical
device communication —
Part 20101:
Application profiles — Base standard
Sponsor
™
IEEE 1073 Standard Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 24 June 2004
IEEE-SA Standards Board
ISO/IEEE 11073-20101:2004(E)
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Abstract: The scope of this standard is upper layer [i.e., the International Organization for
Standardization (ISO’s) open systems interconnection (OSI) application, presentation layer, and
session layer] services and protocols for information exchange under the ISO/IEEE 11073
standards for medical device communications (MDC). This standard is the base standard of the
ISO/IEEE 11073-20000 medical device application profiles (MDAP), as harmonized through the
Committee for European Normalization (CEN) and the ISO.
Keywords: abstract syntax, alarm, alert, communication, control, information model, medical
device, object-oriented, point-of-care, POC, services
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ISO/IEEE 11073-20101:2004(E)
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ISO/IEEE 11073-20101:2004(E)
iv Copyright © 2004 ISO/IEEE. All rights reserved.
ISO/IEEE 11073-20101:2004(E)
ISO 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.
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.
A pilot project between ISO and the IEEE has been formed to develop and maintain a group of ISO/IEEE
standards in the field of medical devices as approved by Council resolution 43/2000. Under this pilot
project, IEEE is responsible for the development and maintenance of these standards with participation and
input from ISO member bodies.
Attention is drawn to the possibility that some of the elements of this International Standard may be the
subject of patent rights. Neither ISO nor the IEEE shall be held responsible for identifying any or all such
patent rights.
ISO/IEEE 11073-20101:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in
Medicine and Biology Society.
ISO/IEEE 11073-20101:2004(E)
IEEE Introduction
This introduction is not part of ISO/IEEE 11073-20101:2004(E), Health informatics — Point-of-care medical device
communication — Part 20101: Application profiles — Base standard.
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems.
They provide automatic and detailed electronic data capture of patient vital signs information and device
operational data. The primary goals are to:
— Provide real-time plug-and-play interoperability for patient-connected medical devices
— Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care,
in all health care environments
“Real-time” means that data from multiple devices can be retrieved, time correlated, and displayed or
processed in fractions of a second. “Plug-and-play” means that all the clinician has to do is make the
connection — the systems automatically detect, configure, and communicate without any other human
interaction.
“Efficient exchange of medical device data” means that information that is captured at the point-of-care
(e.g., patient vital signs data) can be archived, retrieved, and processed by many different types of
applications without extensive software and equipment support, and without needless loss of information.
The standards are especially targeted at acute and continuing care devices, such as patient monitors,
ventilators, infusion pumps, ECG devices, etc. They comprise a family of standards that can be layered
together to provide connectivity optimized for the specific devices being interfaced.
Notice to users
Patents
Attention is called to the possibility that implementation of this standard may require use of subject matter
covered by patent rights. By publication of this standard, no position is taken with respect to the existence or
validity of any patent rights in connection therewith. The IEEE shall not be responsible for identifying
patents or patent applications for which a license may be required by to implement an IEEE standard or for
conducting inquiries into the legal validity or scope of those patents that are brought to its attention.
Errata
Errata, if any, for this and all other standards can be accessed at the following URL: http://
standards.ieee.org/reading/ieee/updates/errata/index.html. Users are encouraged to check this URL for
errata periodically.
Interpretations
Current interpretations can be accessed at the following URL: http://standards.ieee.org/reading/ieee/interp/
index.html.
vi Copyright © 2004 ISO/IEEE. All rights reserved.
ISO/IEEE 11073-20101:2004(E)
Participants
At the time this standard was completed, the working group of the IEEE 1073 Standard Committee had the
following membership:
Todd H. Cooper, Chair
Wolfgang Bleicher Michael Krämer Lief Rystrøm
Francis Cantraine Alberto Macerata Michael Spicer
Todd H. Cooper Simon Meij Lars Steubesand
Michael Flötotto Angelo Rossi Mori Andrew Sutton
Ken Fuchs Thomas Norgall Alpo Värri
Kai Hassing Thomas Penzel Jan Wittenber
Gunther Hellmann Francesco Pinciroli Paul Woolman
Ron Kirkham Rick Revello Christoph Zywietz
Melvin Reynolds
The following members of the individual balloting committee voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Thomas Canup Kai Hassing Melvin Reynolds
Michael Chilbert Tom Kannally Ricardo Ruiz-Fernández
Todd H. Cooper Robert Kennelly Michael Spicer
James (Bob) Davis Randy Krohn M. Michael Shabot
George Economakos Yeou-Song Lee Lars Steubesand
Grace Esche Daniel Nowicki Jan Wittenber
Kenneth Fuchs Gin-Shu Young
When the IEEE-SA Standards Board approved this standard on 24 June 2004, it had the following
membership:
Don Wright, Chair
Steve M. Mills, Vice Chair
Judith Gorman, Secretary
Chuck Adams Mark S. Halpin Paul Nikolich
H. Stephen Berger Raymond Hapeman T. W. Olsen
Mark D. Bowman Richard J. Holleman Ronald C. Petersen
Richard H. Hulett Gary S. Robinson
Joseph A. Bruder
Lowell G. Johnson Frank Stone
Bob Davis
Joseph L. Koepfinger* Malcolm V. Thaden
Roberto de Boisson
Hermann Koch Doug Topping
Julian Forster*
Joe D. Watson
Thomas J. McGean
Arnold M. Greenspan
Daleep C. Mohla
*Member Emeritus
Also included are the following nonvoting IEEE-SA Standards Board liaisons:
Satish K. Aggarwal, NRC Representative
Richard DeBlasio, DOE Representative
Alan Cookson, NIST Representative
Don Messina
IEEE Standards Project Editor
ISO/IEEE 11073-20101:2004(E)
Contents
1. Overview. 1
1.1 Scope. 2
1.2 Purpose. 2
1.3 Goals . 2
1.4 Audience . 2
2. References. 2
3. Definitions and abbreviations . 4
3.1 Definitions . 4
3.2 Acronyms and abbreviations .4
4. Conventions . 6
5. Rationale . 6
5.1 Communication model. 6
5.2 Information model . 7
6. Communication model. 8
6.1 General. 8
6.2 ACSE protocol . 10
6.2.1 General. 10
6.2.2 ACSE services . 10
6.2.3 ACSE ASN.1 message definition . 12
6.2.4 ACSE user information fields. 12
6.3 Session-layer protocol. 12
6.3.1 General. 12
6.3.2 Session-layer services . 12
6.3.3 Session-layer message definitions . 13
6.4 Presentation-layer protocol . 13
6.4.1 General. 13
6.4.2 Presentation-layer services . 14
6.4.3 Presentation-layer messages . 14
6.5 ROSE protocol. 14
6.5.1 General. 14
6.5.2 ROSE services . 14
6.5.3 ROSE message definitions. 14
6.6 CMDISE protocol (CMDIP). 15
6.6.1 General. 15
6.6.2 CMDISE services . 15
6.6.3 CMDIP message definitions . 15
6.6.4 SNTP. 15
7. Information model . 16
7.1 Object model. 16
7.2 Format model. 16
viii Copyright © 2004 ISO/IEEE. All rights reserved.
ISO/IEEE 11073-20101:2004(E)
7.2.1 Syntax . 16
7.2.2 Compatibility . 16
8. Conformance. 17
8.1 Scope. 17
8.2 Object identifier administration .17
8.3 MDAP subset conformance . 17
8.4 Implementation conformance . 17
Annex A (normative) Medical device encoding rules (MDER). 18
Annex B (normative) Allocation of identifiers. 29
Annex C (informative) Time synchronization. 32
Annex D (informative) Dynamic model. 33
Annex E (normative) Abstract syntax . 38
Annex F (informative) PDU examples . 59
Annex G (informative) Specialization of ASN.1.72
Annex H (informative) Compatibility cases. 75
Annex I (informative) Bibliography . 77
Health informatics — Point-of-care medical
device communication —
Part 20101:
Application profiles — Base standard
1. Overview
This standard is divided into eight clauses, as follows:
— Clause 1 provides the scope of this standard.
— Clause 2 lists references to other standards that are useful in applying this standard.
— Clause 3 provides definitions and abbreviations.
— Clause 4 provides conventions.
— Clause 5 provides the rationale for this standard.
— Clause 6 provides a communication, i.e., protocol and service, model.
— Clause 7 provides an information, i.e., object, model.
— Clause 8 provides conformance requirements.
This standard also contains nine annexes, as follows:
— Annex A defines the specialized medical device encoding rules (MDER). (normative)
— Annex B describes the allocation of object identifiers. (normative)
— Annex C provides references to time synchronization protocols applied by this standard.
— Annex D includes state transition diagrams as part of the dynamic model.
— Annex E provides abstract syntax, which offers extensions to leveraged standards, such as minimal
open systems interconnection (mOSI), that are specific to this standard. (normative)
— Annex F includes examples of a number of protocol data unit (PDU) examples.
— Annex G describes a specialization of Abstract Syntax Notation One (ASN.1).
— Annex H deals with compatibility of ASN.1 between the 1988/90 and 1994 versions.
— Annex I provides a bibliography of useful references.
ISO/IEEE 11073-20101:2004(E) HEALTH INFORMATICS — POINT-OF-CARE MEDICAL DEVICE COMMUNICATION
1.1 Scope
The scope of this standard is upper layer [i.e., the International Organization for Standardization's (ISO’s) open
systems interconnection (OSI) application, presentation layer, and session layer] services and protocols for
information exchange under the ISO/IEEE 11073 standards for medical device communications (MDC).
This standard is the base standard of the ISO/IEEE 11073-20000 medical device application profiles
(MDAP), as harmonized through the Committee for European Normalization (CEN) and the ISO.
1.2 Purpose
The purpose of this standard is to define MDC upper layer application, i.e., ISO A-type profiles for inter-
change of data, which are defined by the medical device data language (MDDL) format, or ISO F-type
profiles (ISO/IEEE 11073-10000 series).
1.3 Goals
The primary goal of MDAP standards is to support MDC upper layer data interchange, based on MDDL,
among a wide range, by type and scale, of future and current devices for use in point-of-care (POC) settings
in the acute care sections of hospitals.
1.4 Audience
The primary user of the MDAP standards is a software engineer who is creating a MDC system or attempt-
ing to establish an interface to one.
Because this family of standards is based largely upon international standardization profiles, familiarity with
a range of related standards and technologies is useful if not necessary. The following are recommended as a
minimum background:
™ 1
a) ISO/IEEE 11073 architecture, especially IEEE Std 1073 , ISO/IEEE 11073-10201, and lower
layer standards (e.g., ISO/IEEE 11073-30200)
b) ISO’s OSI layered architecture, primarily the upper layers, i.e., application, presentation, and
session
c) Systems management
d) Object-oriented analysis and design
e) Machine language theory
2. References
This standard shall be used in conjunction with the following publications. When the following standards
are superceded by an approved revision, the revision shall apply.
IEEE Std 1073, IEEE Standard for Medical Device Communications—Overview and Framework.
Information on references can be found in Clause 2.
IEEE publications are available from the Institute of Electrical and Electronics Engineers, Inc., 445 Hoes Lane, Piscataway, NJ 08854,
USA (http://standards.ieee.org/).
2 Copyright © 2004 ISO/IEEE. All rights reserved.
PART 20101: APPLICATION PROFILES — BASE STANDARD ISO/IEEE 11073-20101:2004(E)
ISO/IEC 8327-1, Information technology — Open systems interconnection —Connection-oriented session
protocol — Part 1: Protocol specification. (same as ITU-T Recommendation X.225)
ISO/IEC 8650-1, Information technology — Open systems interconnection — Connection-oriented protocol
for the association control service element — Part 1: Protocol. (same as ITU-T Recommendation X.227)
ISO/IEC 8824-1, Information technology — Abstract Syntax Notation One (ASN.1) — Part 1: Specification
of basic notation. (same as ITU-T Recommendation X.680)
ISO/IEC 8824-2, Information technology — Abstract Syntax Notation One (ASN.1) — Part 2: Information
object specification. (same as ITU-T Recommendation X.681)
ISO/IEC 8825-1, Information technology — ASN.1 encoding rules — Part 1: Specification of Basic Encod-
ing Rules (BER), Canonical Encoding Rules (CER) and Distinguished Encoding Rules (DER). (same as
ITU-T Recommendation X.690)
ISO/IEC 9072-2, Information processing systems — Text communication — Remote operations — Part 2:
Protocol specification.
ISO/IEC 9595, Information technology — Open systems interconnection — Common management infor-
mation service definition.
ISO/IEC 9596-1, Information technology — Open systems interconnecton — Common Management Infor-
mation Protocol — Part 1: Specification.
ISO/IEC 9899, Programming languages — C.
ISO/IEC ISP 11188-3, Information technology — International standardization profile — Common upper
layer requirements — Part 3: Minimal OSI upper layer facilities.
ISO/IEEE 11073-10101, Health informatics — Point-of-care medical device communication — Part 10101:
Nomenclature.
ISO/IEEE 11073-10201, Health informatics — Point-of-care medical device communication — Part 10201:
Domain information model (referred to hereinafter as “the DIM”).
ISO/IEEE 11073-30200, Health informatics — Point-of-care medical device communication — Part 30200:
Transport profile — Cable connected.
ISO/IEEE 11073-30300, Health informatics — Point-of-care medical device communication — Part 30300:
Transport profile — Infrared Wireless.
ITU-T Recommendation X.681, Information Technology—Abstract Syntax Notation One (ASN.1)—Infor-
mation Object Specification. (same as ISO/IEC 8824-2)
ISO/IEC publications are available from the ISO Central Secretariat, Case Postale 56, 1 rue de Varembé, CH-1211, Genève 20, Swit-
zerland/Suisse (http://www.iso.ch/). ISO/IEC publications are also available in the United States from Global Engineering Documents,
15 Inverness Way East, Englewood, CO 80112, USA (http://global.ihs.com/). Electronic copies are available in the United States from
the American National Standards Institute, 25 West 43rd Street, 4th Floor, New York, NY 10036, USA (http://www.ansi.org/).
ISO/IEEE publications are available from the ISO Central Secretariat, Case Postale 56, 1 rue de Varembé, CH-1211, Genève 20, Swit-
zerland/Suisse (http://www.iso.ch/); in the United States from the Sales Department, American National Standards Institute, 25 West
43rd Street, 4th Floor, New York, NY 10036, USA (http://www.ansi.org/); and from the Institute of Electrical and Electronics Engi-
neers, Inc., 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, Swit-
zerland/Suisse (http://www.itu.int/).
ISO/IEEE 11073-20101:2004(E) HEALTH INFORMATICS — POINT-OF-CARE MEDICAL DEVICE COMMUNICATION
3. Definitions and abbreviations
3.1 Definitions
For the purposes of this standard, the following terms and definitions apply. IEEE 100, The Authoritative
Dictionary of IEEE Standards Terms and Definitions, Seventh Edition [B3], should be referenced for terms
not defined in this clause.
3.1.1 abstract syntax: Specification of the structure of a data item without reference to or requirement for a
specific implementation technology.
3.1.2 big endian: A byte order sequence where the most significant byte is sent first. For example, a 32 bit
integer is communicated with the most significant byte (bits 24–31) first and the least significant byte (bits
0–7) last.
3.1.3 byte order: The sequence in which multibyte data primitives are communicated in a protocol data unit
(PDU). For example, a 32 bit integer comprises 4 bytes. See also: big endian.
3.1.4 coalescing: The function of combining multiple presentation-layer protocol data units (PPDUs) into a
single session-layer protocol data unit (SPDU) that is then communicated across a transport.
3.1.5 encoding rules: Specification for how data primitives used in an abstract syntax are converted to an
implementation format. Generally synonymous with transfer syntax.
3.1.6 linked reply: A command response that requires more than one protocol data unit (PDU) to communi-
cate information. For example, a single command to retrieve an entire log file may result in many linked
response PDUs to provide the requested information.
3.1.7 presentation data value (PDV): The union of the sets of values in all possible abstract syntaxes.
3.1.8 transfer syntax: Specification of the structure of data as they are communicated across a transport or
physical medium.
3.2 Acronyms and abbreviations
This following acronyms and abbreviations supplement the acronyms and abbreviations of IEEE Std 1073:
AA (session) abort accept (SPDU)
AARE association response message
AARQ association request message
AB (session) abort (SPDU)
ABRT abort (APDU)
AC (session) accept (SPDU)
ACSE association control service element
AE application entity
AP application process
APDU application protocol data unit
The numbers in brackets correspond to the numbers of the bibliography in Annex I.
A linked command definition and service have been omitted from this version of the standard. This command requires multiple PDUs
to convey the needed information. For example, a command to send a list of drug names to a device may require multiple linked PDUs.
This command may be added to future versions of the standard if required by other profile and optional package standards.
4 Copyright © 2004 ISO/IEEE. All rights reserved.
PART 20101: APPLICATION PROFILES — BASE STANDARD ISO/IEEE 11073-20101:2004(E)
API application program interface
ARP abnormal release provider (PPDU)
ARU abnormal release user (PPDU)
ASN.1 Abstract Syntax Notation One
BCC bedside communication controller
BER basic encoding rules
CC communication controller
CMDIP Common Medical Device Information Protocol
CMIP Common Management Information Protocol
CMISE common management information service element
CMDISE common medical device information service element
CN (session) connect (SPDU)
CP connect presentation (PPDU)
CPA connect presentation accept (PPDU)
CPR connect presentation reject (PPDU)
DCC device communication controller
DICOM Digital Imaging and Communcations in Medicine
DIF device interface
DIM domain information model (see ISO/IEEE 11073-10201.)
DN (session) disconnect (SPDU)
DT (session) data transfer (SPDU)
FN (session) finish (SPDU)
FSM finite state model or machine
LI length indicator
LSB least significant bit
MDAP medical device application profiles (The acronym MDAP may be substituted for
the ISO/IEEE 11073-20000 family of standards.)
MMDAP-DT medical device application profiles normal data transfer (SPDU)
MMDAP-TD medical device application profiles transmit data (PPDU)
MDAP-XT medical device application profiles expedited data transfer (SPDU)
MDC medical device communications or the nomenclature for such communication
(ISO-IEEE 11073-10101)
MDCC medical device communication controller
MDDL medical device data language (The acronym MDDL may be substituted for the
ISO/IEEE 11073-10000 family of standards.)
MDER medical device encoding rules
MDIB medical data information base
MDNF medical device numeric format
MDS medical device system
MDSE medical device service element
MIB management information base
mOSI minimal open systems interconnection
MSB most significant bit
MTU maximum transfer unit
NBO network byte order
OSI open systems interconnection
ISO/IEEE 11073-20101:2004(E) HEALTH INFORMATICS — POINT-OF-CARE MEDICAL DEVICE COMMUNICATION
PDU protocol data unit (also referred to as a message; however, PDU connotes transfer
through a transport profile, e.g., ISO/IEEE 11073-30200).
PDV presentation data value
PER packed encoding rules
PGI parameter group identifier
PI parameter identifier
POC point of care or point-of-care
PPDU presentation-layer protocol data unit
QoS quality of service
RF (session) refuse (SPDU)
ROER remote operation error (APDU)
ROIV remote operation invoke (APDU)
ROLIV remote operation link invoke (APDU)
RORS remote operation result (APDU)
ROSE remote operation service element
SI SPDU identifier
SNTP Simple Network Time Protocol
SPDU session-layer protocol data unit
SS session service
TD presentation data (PPDU)
UML unified modeling language
4. Conventions
Various definitions use prefixed or suffixed symbols to denote specialized or optimized properties. An aster-
isk (*) is appended to some definitions to indicate specialization. For example, BER* refers to a version of
basic encoding rules (BER) that has been significantly optimized for processing efficiency.
5. Rationale
The essential requirement for this standard is to provide a set of abstract and transfer (i.e., encoding rule)
syntaxes that are optimized for use by application profiles and implementations of the domain information
model (DIM).
5.1 Communication model
The following assumptions and requirements are for the base standard and profiles of it regarding the com-
munication stack and related protocol definitions:
— While the communication stack should be based on already existing standards as far as possible, a
primary focus for the protocol definition is on the overall efficiency of implementations (e.g., com-
plexity, resource requirements, bandwidth requirements). It is necessary that even low-end devices
be capable of implementing a communication stack based on this work.
— In order to reduce sending and receiving overhead, the headers added by each layer should, there-
fore, be short and have a fixed data structure without optional or variable size elements.
By avoiding optional components or variable length components in the PDU data type definitions, it
is possible for sending devices to use canned messages (in other words, a message template can be
6 Copyright © 2004 ISO/IEEE. All rights reserved.
PART 20101: APPLICATION PROFILES — BASE STANDARD ISO/IEEE 11073-20101:2004(E)
filled in memory in which only the actual updated values must be copied). Also, for the receiver, this
significantly reduces the complexity of the parser.
This requirement is also strongly related to the requirement for optimized encoding rules.
— The communication stack should be flexible so that other messaging profiles can be accommodated
within the same framework.
The protocol stack is defined by PDU (data) type definitions and dynamic behavior only. The normative
definition of application programming interfaces (APIs) is outside the scope of this standard; however, non-
normative examples may be given to facilitate implementation and reuse.
It is desirable to define a transport-independent interface, although specific mappings of upper layer PDUs
to services of an ISO/IEEE 11073-30000 transport profile is addressed through transport-specific sublayers
as necessary.
General mechanisms at the transport interface to make provisions for information and behavior related to
quality of service (QoS) may be considered.
It is assumed that no complicated session-layer protocol is needed for the communication between medical
devices, especially as some error recov
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