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 Vo Commentaar voor 2003-12-28 Definitief vastgestelde normen zullen als Nederlandse norm gelden. Daarom wordt dit normontwerp in Nederland voor commentaar gepubliceerd. Op het ontwerp ingebracht commentaar zal aan de bevoegde normcommissie worden voorgelegd die hiermee rekening zal houden bij de bepaling van de Nederlandse stem. Indien er geen bezwaar bij NEN wordt ingebracht, kan dat leiden tot ongewijzigd definitieve vaststelling van het ontwerp als norm. Van Europese normen bestaan drie officiële versies: Engels, Frans en Duits. Voor Nederland zal de Engelse versie gelden, tenzij voor een geautoriseerde versie in het Nederlands wordt gekozen. be iew ev Pr or Normcommissie 303 002 "Berichtenverkeer in de Gezondheidszorg" Apart from exceptions provided by the law, nothing from this publication may be duplicated and/or published by means of photocopy, microfilm, storage in computer files or otherwise, which also applies to full or partial processing, without the written consent of the Netherlands Standardization Institute. The Netherlands Standardization Institute shall, with the exclusion of any other beneficiary, collect payments owed by third parties for duplication and/or act in and out of law, where this authority is not transferred or falls by right to the Reproduction Rights Foundation. Auteursrecht voorbehouden. Behoudens uitzondering door de wet gesteld mag zonder schriftelijke toestemming van het Nederlands Normalisatie-instituut niets uit deze uitgave worden verveelvoudigd en/of openbaar gemaakt door middel van fotokopie, microfilm, opslag in computerbestanden of anderszins, hetgeen ook van toepassing is op gehele of gedeeltelijke bewerking. Although the utmost care has been taken with this publication, errors and omissions cannot be entirely excluded. The Netherlands Standardization Institute and/or the members of the committees therefore accept no liability, not even for direct or indirect damage, occurring due to or in relation with the application of publications issued by the Netherlands Standardization Institute. eld Dit document mag slechts op een stand-alone PC worden geinstalleerd. Gebruik op een netwerk is alleen. toestaan als een aanvullende licentieovereenkomst voor netwerkgebruik met NEN is afgesloten. This document may only be used on a stand-alone PC. Use in a network is only permitted when a supplementary license agreement for us in a network with NEN has been concluded. Als Europees normontwerp is gepubliceerd: prEN ISO 11073-30300:2003,IDT Hoewel bij deze uitgave de uiterste zorg is nagestreefd, kunnen fouten en onvolledigheden niet geheel worden uitgesloten. Het Nederlands Normalisatie-instituut en/of de leden van de commissies aanvaarden derhalve geen enkele aansprakelijkheid, ook niet voor directe of indirecte schade, ontstaan door of verband houdend met toepassing van door het Nederlands Normalisatie-instituut gepubliceerde uitgaven. Het Nederlands Normalisatie-instituut is met uitsluiting van ieder ander gerechtigd de door derden verschuldigde vergoedingen voor verveelvoudiging te innen en/of daartoe in en buiten rechte op te treden, voor zover deze bevoegdheid niet is overgedragen c.q. rechtens toekomt aan de Stichting Reprorecht. ©2002 Nederlands Normalisatie-instituut Postbus 5059, 2600 GB Delft Telefoon (015) 2 690 390, Fax (015) 2 690 190 Dit document is een voorbeeld van NEN / This document is a preview by NEN be iew ev Pr or Vo eld 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 Vo 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) or 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. Pr 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. ev be 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. iew 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. eld 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 Dit document is een voorbeeld van NEN / This document is a preview by NEN 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. Vo Endorsement notice The text of ISO 11073-30300:2003 has been approved by CEN as prEN ISO 1107330300:2003 without any modifications. be iew ev Pr or eld 2 Dit document is een voorbeeld van NEN / This document is a preview by NEN 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 Vo 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 be iew ev Pr or ICS 35.240.80 eld 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 Dit document is een voorbeeld van NEN / This document is a preview by NEN ISO/IEEE DIS 11073-30300:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. Neither the ISO Central Secretariat nor IEEE accepts any liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for 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 IEEE at the address given below. be iew ev Pr or Vo Copyright notice eld This ISO/IEEE document is a Draft International Standard and is copyright-protected by ISO and IEEE. Except as permitted under the applicable laws of the user’s country, neither this ISO/IEEE draft nor any extract from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or otherwise, without prior written permission being secured. Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s member body in the country of the requester. In the United States, such requests should be sent to IEEE. ISO copyright office Case postale 56 x CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyright@iso.org Web www.iso.org Institute of Electrical and Electronics Engineers, Inc. 3 Park Avenue New York NY 10016-5997 USA Tel. + 1 212 419 7900 Fax + 1 212 752 4929 E-mail copyright@ieee.org Web www.ieee.org Reproduction may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. ii © ISO/IEEE 2003 – All rights reserved Dit document is een voorbeeld van NEN / This document is a preview by NEN ISO/IEEE DIS 11073-30300:2003(E) Foreword Vo 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. or 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. be iew ev Pr eld © ISO/IEEE 2003 – All rights reserved Dit document is een voorbeeld van NEN / This document is a preview by NEN iii be iew ev Pr or Vo eld 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 Vo 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 be ev Pr ISO Copyright notice iew 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. eld 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: Chris Sedlacek ISO TC215 secretariat 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. 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 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. Vo 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 be iew ev Pr or eld 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. Vo 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. Pr or 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. ev be This standard also extends IEEE Std 1073.3.2™ in several important areas: iew 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. eld 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. 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 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 Vo 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. or 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. be iew ev Pr eld Page 4 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 Bestelformulier Stuur naar: NEN Standards Products & Services t.a.v. afdeling Klantenservice Antwoordnummer 10214 2600 WB Delft NEN Standards Products & Services Postbus 5059 2600 GB Delft Vlinderweg 6 2623 AX Delft T (015) 2 690 390 F (015) 2 690 271 Ja, ik bestel __ ex. NEN-EN-ISO 11073-30300:2003 Ontw. en Medische informatica Communicatie van medische apparaten op de zorgplek - Deel 30300: Transport profiel - IrDA gebaseerd - Draadloos infrarood www.nen.nl/normshop € 51.12 Wilt u deze norm in PDF-formaat? 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