Nederlandse norm. Vervangt NEN-ISO/IEEE :2010. ICS ; maart 2011

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1 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. Nederlandse norm NEN-EN-ISO (en) Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter (ISO/IEEE :2010,IDT) Vervangt NEN-ISO/IEEE :2010 ICS ; maart 2011

2 NEN-EN-ISO Als Nederlandse norm is aanvaard: - EN ISO :2011,IDT - ISO/IEEE :2010,IDT Normcommissie "Informatievoorziening in de zorg" 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. 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. 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. 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 Nederlands Normalisatie-instituut Postbus 5059, 2600 GB Delft Telefoon (015) , Fax (015)

3 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM NEN-EN-ISO :2011 EN ISO March 2011 ICS English Version Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter (ISO/IEEE :2010) Informatique de santé - Communication entre dispositifs de santé personnels - Partie 10404: Spécialisation des disposititfs - Oxymètre de pouls (ISO/IEEE :2010) Medizinische Informatik - Kommunikation von Geräten für die persönliche Gesundheit - Teil 10404: Gerätespezifikation - Pulsoximeter (ISO/IEEE :2010) This European Standard was approved by CEN on 23 April 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 worldwide for CEN national Members. Ref. No. EN ISO :2011: E

4 EN ISO :2011 (E) NEN-EN-ISO :2011 Contents Foreword...3 Page 2

5 NEN-EN-ISO :2011 EN ISO :2011 (E) Foreword The text of ISO/IEEE :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 :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 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 :2010 has been approved by CEN as a EN ISO :2011 without any modification. 3

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7 NEN-EN-ISO :2011 INTERNATIONAL STANDARD ISO/IEEE First edition Health informatics Personal health device communication Part 10404: Device specialization Pulse oximeter Informatique de santé Communication entre dispositifs de santé personnels Partie 10404: Spécialisation des disposititfs Oxymètre de pouls Reference number ISO/IEEE :2010(E) ISO 2010 IEEE 2010

8 ISO/IEEE :2010(E) NEN-EN-ISO :2011 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. COPYRIGHT PROTECTED DOCUMENT ISO 2010 IEEE 2010 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO or IEEE at the respective address below. ISO copyright office Institute of Electrical and Electronics Engineers, Inc. Case postale 56 CH-1211 Geneva 20 3 Park Avenue, New York NY , USA Tel stds.ipr@ieee.org Fax Web copyright@iso.org Web Published in Switzerland ii ISO 2010 All rights reserved IEEE 2010 All rights reserved

9 NEN-EN-ISO :2011 ISO/IEEE :2010(E) Contents Page Foreword... v Introduction...vii 1. Overview Scope Purpose Context Normative references Definitions, acronyms, and abbreviations Definitions Acronyms and abbreviations Introduction to ISO/IEEE personal health devices General Introduction to IEEE modeling constructs Pulse oximeter device concepts and modalities General Device types General concepts Collected data Derived data Stored data Device configurations Pulse oximeter DIM Overview Class extensions Object instance diagram Types of configuration MDS object Numeric objects Real-time sample array (RT-SA) objects Enumeration objects PM-store objects Scanner objects Class extension objects Pulse oximeter information model extensibility rules ISO 2010 All rights reserved IEEE 2010 All rights reserved iii

10 ISO/IEEE :2010(E) NEN-EN-ISO : Pulse oximeter service model General Object access services Object access EVENT REPORT services Pulse oximeter communication model Overview Communications characteristics Association procedure Configuring procedure Operating procedure Time synchronization Test associations Behavior with standard configuration Behavior with extended configurations Conformance Applicability Conformance specification Levels of conformance Implementation conformance statements (ICSs) Annex A (informative) Bibliography Annex B (normative) Additional ASN.1 definitions Annex C (normative) Allocation of identifiers Annex D (informative) Message sequence examples Annex E (informative) PDU examples iv ISO 2010 All rights reserved IEEE 2010 All rights reserved

11 NEN-EN-ISO :2011 ISO/IEEE :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 was prepared by the Committee of the Engineering in Medicine and Biology Society of the IEEE (as IEEE Std ). 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 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 Part 10407: Device specialization Blood pressure monitor ISO 2010 All rights reserved IEEE 2010 All rights reserved v

12 ISO/IEEE :2010(E) NEN-EN-ISO :2011 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 vi ISO 2010 All rights reserved IEEE 2010 All rights reserved

13 Bestelformulier Stuur naar: NEN Standards Products & Services t.a.v. afdeling Klantenservice Antwoordnummer WB Delft NEN Standards Products & Services Postbus GB Delft Vlinderweg AX Delft Ja, ik bestel ex. NEN-EN-ISO :2011 en Medische informatica - Communicatie tussen persoonlijke gezondheidsapparaten- Deel 10404: Apparaat specialisatie - Pols oximeter T (015) F (015) Wilt u deze norm in PDF-formaat? Deze bestelt u eenvoudig via Gratis nieuwsbrieven Wilt u op de hoogte blijven van de laatste ontwikkelingen op het gebied van normen, normalisatie en regelgeving? Neem dan een gratis abonnement op een van onze nieuwsbrieven. Gegevens Bedrijf / Instelling T.a.v. O M O V Klantnummer NEN Uw ordernummer BTW nummer Postbus / Adres Postcode Plaats Telefoon Fax Factuuradres (indien dit afwijkt van bovenstaand adres) Postbus / Adres Postcode Plaats Datum Handtekening Retourneren Fax: klantenservice@nen.nl Post: NEN Standards Products & Services, t.a.v. afdeling Klantenservice Antwoordnummer 10214, 2600 WB Delft (geen postzegel nodig). Voorwaarden De prijzen zijn geldig tot 31 december 2018, tenzij anders aangegeven. Alle prijzen zijn excl. btw, verzend- en handelingskosten en onder voorbehoud bij o.m. ISO- en IEC-normen. Bestelt u via de normshop een pdf, dan betaalt u geen handeling en verzendkosten. Meer informatie: telefoon , dagelijks van 8.30 tot uur. Wijzigingen en typefouten in teksten en prijsinformatie voorbehouden. U kunt onze algemene voorwaarden terugvinden op: LEREN, WERKEN EN GROEIEN MET NEN preview