Health informatics - Point-of-care medical device communication - Part 30200: Transport profile - Cable connected (ISO/IEEE 11073-30200:2004)

The scope of this standard is an IrDA-based, cable-connected local area network (LAN) for the interconnection
of computers and medical devices. This standard is suitable for new device designs, but is particularly
targeted to modifications of legacy devices.
The term “legacy devices” refers to equipment that is
— Already in use in clinical facilities
— In active production at the facilities of medical device manufacturers, or
— Beyond the initial stages of engineering development
In each of these cases, the degree of effort to add a standardized communications capability might normally
be prohibitive, unless special care is taken in developing a suitable standard.

Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil 30200: Transportprofil - drahtgebundene Übertragung

Informatique de santé - Communication entre dispositifs médicaux sur le site des soins - Partie 30200: Profil de transport - Connexion par câble (ISO/IEEE 11073-30200:2004)

L'ISO/IEEE 11073-30200:2004 est un réseau local (LAN) connecté par câble et basé sur le protocole IrDa pour l'interconnexion d'ordinateurs et de dispositifs médicaux. La présente norme est adaptée aux nouvelles conceptions de dispositifs, mais cible en particulier les modifications apportées aux dispositifs existants.
L'expression «dispositifs existants» désigne les équipements
       déjà utilisés dans les sites cliniques;
       en production active dans les sites de fabrication de dispositifs médicaux, ou
       ayant dépassé les étapes initiales de développement technique.

Zdravstvena informatika – Komunikacija medicinskih naprav na mestu oskrbe – 30200. del: Transportni profil – Kabelsko priključen (ISO/IEEE 11073-30200:2004)

Področje uporabe tega standarda je kabelsko priključeno lokalno omrežje (LAN) na osnovi IrDA za medomrežno povezovanje računalnikov in medicinskih naprav. Ta standard je primeren za nove modele naprav, še posebej pa je namenjen spremembam starejših naprav.
Izraz »starejše naprave« se nanaša na opremo, ki
– se že uporablja v kliničnih objektih,
– je v aktivni proizvodnji v obratih proizvajalcev medicinskih naprav ali
– ni več v začetnih fazah inženirskega razvoja.
V vseh naštetih primerih bi bilo običajno zelo težko dodati standardizirane komunikacijske zmogljivosti, če ne bi posebej pazljivo razvili ustreznega standarda.

General Information

Status
Published
Publication Date
31-Oct-2005
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
01-Nov-2005
Due Date
01-Nov-2005
Completion Date
01-Nov-2005

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SLOVENSKI STANDARD
SIST EN ISO 11073-30200:2005
01-november-2005
=GUDYVWYHQDLQIRUPDWLND±.RPXQLNDFLMDPHGLFLQVNLKQDSUDYQDPHVWXRVNUEH±
GHO7UDQVSRUWQLSURILO±.DEHOVNRSULNOMXþHQ ,62,(((
Health informatics - Point-of-care medical device communication - Part 30200: Transport
profile - Cable connected (ISO/IEEE 11073-30200:2004)
Medizinische Informatik - Kommunikation patientennaher medizinischer Geräte - Teil
30200: Transportprofil - drahtgebundene Übertragung
Informatique de santé - Communication entre dispositifs médicaux sur le site des soins -
Partie 30200: Profil de transport - Connexion par câble (ISO/IEEE 11073-30200:2004)
Ta slovenski standard je istoveten z: EN ISO 11073-30200:2005
ICS:
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN ISO 11073-30200:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11073-30200:2005

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SIST EN ISO 11073-30200:2005
EUROPEAN STANDARD
EN ISO 11073-30200
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2005
ICS 35.240.80

English Version
Health informatics - Point-of-care medical device communication
- Part 30200: Transport profile - Cable connected (ISO/IEEE
11073-30200:2004)
Informatique de santé - Communication entre dispositifs Medizinische Informatik - Kommunikation patientennaher
médicaux sur le site des soins - Partie 30200: Profil de medizinischer Geräte - Teil 30200: Transportprofil -
transport - Connexion par câble (ISO/IEEE 11073- drahtgebundene Übertragung
30200:2004)
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 11073-30200:2005: E
worldwide for CEN national Members.

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SIST EN ISO 11073-30200:2005
EN ISO 11073-30200:2005 (E)






Foreword



The text of ISO/IEEE 11073-30200:2004 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 11073-30200:2005 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 11073-30200:2004 has been approved by CEN as EN ISO 11073-
30200:2005 without any modifications.

2

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SIST EN ISO 11073-30200:2005
INTERNATIONAL
ISO/IEEE
STANDARD
11073-30200
First edition
2004-12-15
Health informatics — Point-of-care
medical device communication —
Part 30200:
Transport profile — Cable connected
Informatique de santé — Communication entre dispositifs médicaux sur le
site des soins —
Partie 30200: Profil de transport — Connection par câble
Reference number
ISO/IEEE 11073-30200:2004(E)
© ISO/IEEE 2004

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SIST EN ISO 11073-30200:2005

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SIST EN ISO 11073-30200:2005
ISO/IEEE 11073-30200:2004(E)
Health informatics — Point-of-care
medical device communication —
Part 30200:
Transport profile — Cable connected
Sponsor

IEEE 1073 Standard Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 30 January 2000
IEEE-SA Standards Board

---------------------- Page: 7 ----------------------

SIST EN ISO 11073-30200:2005
ISO/IEEE 11073-30200:2004(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe’s licensing policy, this file may be printed
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Details of the software products used to create this PDF file can be found in the General Info relative to the file; the
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use by ISO member bodies and IEEE members. In the unlikely event that a problem relating to it is found, please
inform the ISO Central Secretariat or the IEEE at the address given below.
Abstract: A connection-oriented transport profile and physical layer suitable for medical device
communications in legacy devices is established. Communications services and protocols
consistent with specifications of the Infrared Data Association are defined. These communication
services and protocols are optimized for use in patient-connected bedside medical devices.
Keywords: bedside, Infrared Data Association, IrDA, legacy device, medical device, medical
device communications, MIB, patient, SNTP
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No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without the prior
written permission of the publisher.
ii Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-30200:2005

ISO/IEEE 11073-30200:2004(E)
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 develop-
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Copyright © 2004 ISO/IEEE. All rights reserved. iii

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SIST EN ISO 11073-30200:2005
ISO/IEEE 11073-30200:2004(E)
iv Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-30200:2005

ISO/IEEE 11073-30200:2004(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 11073-30200:2004(E) was prepared by IEEE 1073 Committee of the IEEE Engineering in
Medicine and Biology Society.
Copyright © 2004 ISO/IEEE. All rights reserved. v

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SIST EN ISO 11073-30200:2005
ISO/IEEE 11073-30200:2004(E)
IEEE Introduction
This introduction is not part of ISO/IEEE 11073-30200:2004(E), Health informatics — Point-of-care medical device
communication — Part 30200: Transport profile — Cable connected.
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 pro-
cessed 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.
ISO/IEEE 11073-30200:2004(E) defines a communications transport profile. This profile is for a cable-con-
nected local area network (LAN) for the interconnection of computers and medical devices. This standard is
suitable for new device designs, but is particularly targeted to modifications of legacy devices.
The term “legacy devices” refers to equipment that is
— Already in use in clinical facilities
— In active production at the facilities of medical device manufacturers, or
— Beyond the initial stages of engineering development
Specifically, this standard describes connection-oriented communications services and protocols consistent
with standards of the Infrared Data Association (IrDA), adapted as appropriate for ISO/IEEE 11073 applica-
tions and optimized for use in patient-connected bedside medical devices.
ISO/IEEE 11073-30200:2004(E) is one part of the family of ISO/IEEE 11073 standards. It is compatible
with the upper layer ISO/IEEE 11073 standards.
The primary users of this standard are technical personnel who are creating or interfacing with a medical
device communications system. Familiarity with the ISO/IEEE 11073 family of standards is recommended.
Familiarity with communications and networking technologies is also recommended.
This standard is intended to satisfy the following objectives:
a) Allow compatibility with existing medical device communications designs to minimize design risk,
contain product costs, and simplify field upgrades
b) Specify hardware and software elements that are available from multiple vendors
c) Make use of other computer industry communication technology to allow for continuous cost
decreases

d) Meet the requirements of IEEE Std 1073 -1996
e) Be compatible with the current published and draft ISO/IEEE standard upper layers
vi Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-30200:2005

ISO/IEEE 11073-30200:2004(E)
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.
Participants
At the time this guide was completed, the Legacy Device Working Group of the IEEE 1073 Committee had
the following membership:
Allen Farquhar, Chair
Kenneth Hall
Todd Cooper Ward Silver
Kenneth J. Fuchs Dick Myrick Lars Steubesand
Harald Greiner Daniel Nowicki Jan Wittenber
Paul Schluter
Other individuals who have contributed to this document include
Frank Enslin Tom Luteran Bob Meijer
George Kriegl Carol Pellegrini
The following members of the balloting committee voted on this standard:
Teresa J. Cendrowska Harald Greiner Daniel Nowicki
Allen Farquhar Bill Hawley Melvin Reynolds
Ricardo Ruiz Fernandez Debra Herrmann M. Michael Shabot
Kenneth J. Fuchs Robert J. Kennelly Lars Steubesand
William McMullen
Copyright © 2004 ISO/IEEE. All rights reserved. vii

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SIST EN ISO 11073-30200:2005
ISO/IEEE 11073-30200:2004(E)
When the IEEE-SA Standards Board approved this standard on 30 January 2000, it had the following
membership:
Richard J. Holleman, Chair
Donald N. Heirman, Vice Chair
Judith Gorman, Secretary
Satish K. Aggarwal James H. Gurney Louis-François Pau
Dennis Bodson Lowell G. Johnson Ronald C. Petersen
Mark D. Bowman Robert J. Kennelly Gerald H. Peterson
James T. Carlo E. G. “Al” Kiener John B. Posey
Gary R. Engmann Joseph L. Koepfinger* Gary S. Robinson
Harold E. Epstein L. Bruce McClung Akio Tojo
Jay Forster* Daleep C. Mohla Hans E. Weinrich
Ruben D. Garzon Robert F. Munzner Donald W. Zipse
*Member Emeritus
Also included is the following nonvoting IEEE-SA Standards Board liaison:
Robert E. Hebner
Yvette Ho Sang
Don Messina
IEEE Standards Project Editors
viii Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-30200:2005
ISO/IEEE 11073-30200:2004(E)
CONTENTS
1. Overview. 1
1.1 Scope. 2
1.2 Purpose. 2
1.3 Standards compatibility . 2
1.4 Audience . 2
2. References. 2
3. Definitions, acronyms, and abbreviations. 4
3.1 Definitions . 4
3.2 Acronyms and abbreviations . 6
4. Goals for this standard . 7
5. Architecture . 7
5.1 Topology. 7
5.2 Layering . 9
6. Physical layer. 9
7. Data link layer. 10
7.1 IrLAP frame. 10
7.2 Procedure model . 11
7.3 Minimum data link layer requirements. 12
8. Network layer . 15
8.1 Discovery information . 15
8.2 Information access requirements . 17
8.3 Minimum IrLMP multiplexer requirements . 19
9. Transport layer. 20
9.1 Maximum transfer unit . 20
9.2 Transport service requirements. 21
9.3 MDDL service . 22
10. Time synchronization . 22
11. Labeling and conformance requirements. 23
11.1 Labeling requirements . 23
11.2 Conformance requirements. 23
Annex A (normative) Physical layer. 24
Annex B (informative) Maximum cable length . 35
Annex C (informative) Modular connectors . 37
Copyright © 2004 ISO/IEEE. All rights reserved. ix

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SIST EN ISO 11073-30200:2005
ISO/IEEE 11073-30200:2004(E)
Annex D (informative) RJ-45 to DB-9 modular adapters . 39
Annex E (informative) Detailed rationale for pin assignments . 40
Annex F (informative) 10BASE-T . 41
Annex G (informative) Power delivery considerations. 42
Annex H (informative) Nonisolated BCC and DCC design examples . 43
Annex I (informative) Isolated BCC design example.45
Annes J (informative) Optical isolator design example .47
Annex K (informative) Marking guidelines . 49
Annex L (informative) IrDA message examples . 52
Annex M (normative) IrDA profile . 58
Annex N (informative) Time synchronization using SNTP. 61
Annex O (informative) Bibliography . 69
x Copyright © 2004 ISO/IEEE. All rights reserved.

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SIST EN ISO 11073-30200:2005
Health informatics — Point-of-care

medical device communication
Part 30200:
Transport profile — Cable connected
1. Overview
This standard is divided into 11 clauses, as follows:
— Clause 1 provides an overview 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 goals for this standard.
— Clause 5 provides an overview of network topology and layering.
— Clause 6 provides a profile of the physical layer.
— Clause 7 provides a profile of the data link layer.
— Clause 8 provides a profile of the network layer.
— Clause 9 provides a profile of the transport layer.
— Clause 10 describes the optional time synchronization service.
— Clause 11 provides labeling and conformance requirements.
This standard also contains 15 annexes, as follows:
— Annex A describes the physical layer.
— Annex B provides information on the maximum cable length.
— Annex C provides examples of physical link media.
— Annex D provides example schematics for modular adapters.
— Annex E provides a detailed rationale for pin assignments.
— Annex F descr
...

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