Nederlandse
Ontwerp
norm
NEN-EN-ISO 11073-30300
Health informatics - Point-of-care medical
device communications - Part 30300:
Transport profile - IrDA based - Infrared
wireless (ISO/IEEE DIS 1107330300:2003,IDT)
Publicatie uitsluitend voor commentaar
oktober 2003
ICS 35.240.80
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Commentaar voor 2003-12-28
Definitief vastgestelde normen zullen als Nederlandse norm gelden. Daarom wordt dit normontwerp in Nederland voor
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tenzij voor een geautoriseerde versie in het Nederlands wordt gekozen.
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Normcommissie 303 002 "Berichtenverkeer in de Gezondheidszorg"
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Als Europees normontwerp is gepubliceerd: prEN ISO 11073-30300:2003,IDT
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Dit document is een voorbeeld van NEN / This document is a preview by NEN
DRAFT
prEN ISO 11073-30300
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2003
ICS
English version
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Health informatics - Point-of-care medical device
communications - Part 30300: Transport profile - IrDA based Infrared wireless (ISO/DIS 11073-30300:2003)
Informatique de santé - Communications des dispositifs
médicaux <<point-of-care>> - Partie 30300: Profil de
transport - <<IrDA based>> - Radio à infrarouges (ISO/DIS
11073-30300:2003)
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This draft European Standard is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee
CEN/TC 251.
If this draft becomes a European Standard, 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.
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This draft European Standard was established by CEN 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 Management Centre has
the same status as the official versions.
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CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
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Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
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EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36
© 2003 CEN
All rights of exploitation in any form and by any means reserved
worldwide for CEN national Members.
B-1050 Brussels
Ref. No. prEN ISO 11073-30300:2003 E
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prEN ISO 11073-30300:2003 (E)
Foreword
This document (prEN ISO 11073-30300:2003) has been prepared by Technical Committee
ISO/TC 215 "Health informatics" in collaboration with Technical Committee CEN/TC 251
"Health informatics", the secretariat of which is held by SIS.
This document is currently submitted to the parallel Enquiry.
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Endorsement notice
The text of ISO 11073-30300:2003 has been approved by CEN as prEN ISO 1107330300:2003 without any modifications.
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DRAFT INTERNATIONAL STANDARD
ISO/IEEE DIS 11073-30300
ISO/TC 215
Voting begins on 2003-08-28
Secretariat: ANSI
Voting terminates on 2004-01-28
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION x ɆȿɀȾɍɇȺɊɈȾɇȺə ɈɊȽȺɇɂɁȺɐɂə ɉɈ ɋɌȺɇȾȺɊɌɂɁȺɐɂɂ x ORGANISATION INTERNATIONALE DE NORMALISATION
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Health informatics — Point-of-care medical device
communications —
Part 30300:
Transport profile — IrDA based — Infrared wireless
Informatique de santé — Communications des dispositifs médicaux «point-of-care» —
Partie 30300: Profil de transport — «IrDA based» — Radio à infrarouges
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ICS 35.240.80
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ISO/CEN PARALLEL ENQUIRY
The CEN Secretary-General has advised the ISO Secretary-General that this ISO/DIS covers a
subject of interest to European standardization. In accordance with the ISO-lead mode of
collaboration as defined in the Vienna Agreement, consultation on this ISO/DIS has the same
effect for CEN members as would a CEN enquiry on a draft European Standard. Should this draft
be accepted, a final draft, established on the basis of comments received, will be submitted to a
parallel two-month FDIS vote in ISO and formal vote in CEN.
In accordance with the provisions of Council Resolution 15/1993 this document is circulated
in the English language only.
Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est
distribué en version anglaise seulement.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO
AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH
REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2003
© Institute of Electrical and Electronics Engineers, Inc., 2003
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ISO/IEEE DIS 11073-30300:2003(E)
PDF disclaimer
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Copyright notice
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Except as permitted under the applicable laws of the user’s country, neither this ISO/IEEE draft nor any
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© ISO/IEEE 2003 – All rights reserved
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ISO/IEEE DIS 11073-30300:2003(E)
Foreword
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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 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.
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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 IEEE shall be held responsible for identifying any or all such patent rights.
International Standard ISO/IEEE 11073-30300 was developed by IEEE and by Technical Committee
ISO/TC 215, Health informatics.
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© ISO/IEEE 2003 – All rights reserved
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IEEE P1073.3.3 / D7, June 2003
ISO/IEEE P11073-30300/D7
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IEEE P1073.3.3™ / D7
(ISO/IEEE P11073-30300/D7)
Draft for Medical Device Communications –
Transport Profile –
IrDA Based –
Infrared Wireless
Copyright © 2003 by the Institute of Electrical and Electronics Engineers, Inc.
Three Park Avenue
New York, New York 10016-5997, USA
All rights reserved.
or
This document is an unapproved draft of a proposed IEEE Standard. As such, this document is subject to change.
USE AT YOUR OWN RISK! Because this is an unapproved draft, this document must not be utilized for any
conformance/compliance purposes. Permission is hereby granted for IEEE Standards Committee participants to
reproduce this document for purposes of IEEE standardization activities only. Prior to submitting this document to
another standards development organization for standardization activities, permission must first be obtained from the
Manager, Standards Licensing and Contracts, IEEE Standards Activities Department. Other entities seeking
permission to reproduce this document, in whole or in part, must obtain permission from the Manager, Standards
Licensing and Contracts, IEEE Standards
Activities Department.
IEEE Standards Activities Department
Standards Licensing and Contracts
445 Hoes Lane, P.O. Box 1331
Piscataway, NJ 08855-1331, USA
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ISO Copyright notice
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This ISO document is a working draft or committee draft and is copyright-protected by ISO. While
the reproduction of working drafts or committee drafts in any form for use by participants in the ISO
standards development process is permitted without prior permission from ISO, neither this
document nor any extract from it may be reproduced, stored or transmitted in any form for any other
purpose without prior written permission from ISO.
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Requests for permission to reproduce this document for the purpose of selling it should be
addressed as shown below or to ISO’s member body in the country of the requester:
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ASTM
Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
Warning
This document is not an ISO International Standard. It is distributed for review and comment. It is subject
to change without notice and may not be referred to as an International Standard.
Recipients of this document are invited to submit, with their comments, notification of any relevant patent
rights of which they are aware and to provide supporting documentation.
Page 1 of 70
Copyright ¤ 2003 IEEE and ISO. All rights reserved
This is an unapproved IEEE and ISO Standards Draft, subject to change.
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IEEE P1073.3.3 / D7, June 2003
ISO/IEEE P11073-30300/D7
Abstract: This standard establishes a connection-oriented transport profile and physical layer
suitable for medical device communications that use short-range infrared wireless. This standard
defines communications services and protocols consistent with specifications of the Infrared Data
Association, and are optimized for ‘point-of-care’ applications at or near the patient.
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Keywords: access point, bedside, device interfaces, infrared, Infrared Data Association, IrDA,
medical device, medical device communications, Medical Information Bus, MIB, patient, Simple
Network Time Protocol, SNTP, point-of-care, POC, point-of-care testing, POCT, wireless
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Page 2 of 70
Copyright ¤ 2003 IEEE and ISO. All rights reserved
This is an unapproved IEEE and ISO Standards Draft, subject to change.
Dit document is een voorbeeld van NEN / This document is a preview by NEN
IEEE P1073.3.3 / D7, June 2003
ISO/IEEE P11073-30300/D7
Introduction
This standard defines a communications transport profile. This profile supports short-range, point-to-point
infrared wireless communication between medical devices, network access points, computers and other
medical data systems. This standard is suitable for new device designs but can also be implemented as an
adaptation or modification of existing legacy devices.
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Specifically, this standard describes connection-oriented communications services and protocols consistent
with standards of the Infrared Data Association (IrDA). The use of IrDA-infrared is especially appropriate
for mobile and portable ‘point-of-care’ (POC) clinical lab instruments (e.g. glucose meters) and other
medical devices that require intermittent ‘point-and-shoot’ connectivity to a data repository.
This standard is one part of the family of IEEE 1073™ (also known as "ISO/IEEE 11073") standards. It is
a companion standard to IEEE Std 1073.3.2™ “Standard for Medical Device Communications –
Transport Profile – IrDA Based – Cable Connected”. Since both standards use the same IrDA-based
transport protocols, software development costs are reduced and the implementation of simple, low-cost
cable-to-infrared adapters is facilitated.
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Like IEEE Std 1073.3.2, this standard is compatible with ISO/IEEE 11073 upper layer standards (e.g.,
ISO/IEEE standards with document designators ISO/IEEE 11073-1xxxx and ISO/IEEE 11073-2xxxx). It
is also fully compatible with (and largely based on) the Connectivity Industry Consortium (CIC) and the
National Committee for Clinical Laboratory Standards (NCCLS) Point-Of-Care Connectivity; Approved
Standard (NCCLS POCT1) ‘Device and Access Point Specification’ and is capable of supporting the
‘Device Messaging Layer’ upper layer device protocol developed by those organizations for point-of-care
diagnostic devices.
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This standard also extends IEEE Std 1073.3.2™ in several important areas:
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1. Defines two additional client-server models for medical device interaction that support the NCCLS
POCT1 communication model.
2. Specifies and provides recommendations for how a network access point acts as a relay between the
IrDA TinyTP connection to the medical device and a TCP/IP connection to a remote host on the
network, and the information that is registered at an Access Point regarding the network services
provided by one or more remote hosts.
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Although not formally required by this standard, a key objective is that it should be possible to build a
Common Access Point that can support ISO/IEEE 11073 and NCCLS point-of-care medical devices as
well as handheld Personal Digital Assistants (PDAs), regardless of differences between their upper-layer
protocols and clinical application.
Page 3 of 70
Copyright ¤ 2003 IEEE and ISO. All rights reserved
This is an unapproved IEEE and ISO Standards Draft, subject to change.
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IEEE P1073.3.3 / D7, June 2003
ISO/IEEE P11073-30300/D7
Participants and Acknowledgements
At the time this standard was completed, the IEEE 1073.3.3 working group had the following
membership:
Paul Schluter, Editor and Working Group Chair
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Todd Cooper
Kai Hassing
Daniel Nowicki
Lars Steubesand
Andrew Sutton
The working group also wishes to recognize the contribution of the Connectivity Industry Consortium
Device and Access Point Working Group, which included Paul Schluter, David Ma, Alan Greenburg, Bob
Uleski, Imre Trefil, Joe Rogers, Mark Maund and Dan Nowicki, and the overall technical leadership of the
Connectivity Industry Consortium provided by Jeff Perry.
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The IEEE 1073.3.3 Working Group and the IEEE also recognize the efforts and contributions of the
NCCLS POCT1 ‘Point-of-Care Connectivity’ subcommittee, chaired by Jeffrey A. DuBois, and thank
the NCCLS for granting the IEEE permission to use portions of POCT1 (Point-of-Care Connectivity;
Approved Standard) in this document.
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Page 4 of 70
Copyright ¤ 2003 IEEE and ISO. All rights reserved
This is an unapproved IEEE and ISO Standards Draft, subject to change.
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