Nederlandse norm. NEN-EN-IEC (en)

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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-IEC (en) Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz (IEC 61689:2013,IDT) Vervangt NEN-EN-IEC 61689:2007 ICS mei 2013

2 NEN-EN-IEC Als Nederlandse norm is aanvaard: - EN 61689:2013,IDT - IEC 61689:2013,IDT Normcommissie "Elektro-akoestiek en ultrageluid" THIS PUBLICATION IS COPYRIGHT PROTECTED DEZE PUBLICATIE IS AUTEURSRECHTELIJK BESCHERMD 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 NEN-EN-IEC Nederlands voorwoord Voor de in deze norm vermelde normatieve verwijzingen bestaan in Nederland de volgende equivalenten: vermelde norm Nederlandse norm titel IEC HD Safety of medical electrical equipment - Part 1: General requirements IEC NEN-EN-IEC Medische elektrische toestellen - Deel 2-5: Bijzondere veiligheidseisen voor ultrasone fysiotherapietoestellen IEC 61161: IEC :2007/A1:2013 NEN-EN-IEC :2007/A1:2013 Ultrasone technologie - Hydrofoons - Deel 1: Meetmethoden en karakterisering van medische ultrasone technologievelden tot 40 MHz

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5 EUROPEAN STANDARD EN NORME EUROPÉENNE EUROPÄISCHE NORM April 2013 ICS Supersedes EN 61689:2007 English version Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz (IEC 61689:2013) Ultrasons - Systèmes de physiothérapie - Spécifications des champs et méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz (CEI 61689:2013) Ultraschall - Physiotherapiesysteme - Feldspezifikation und Messverfahren im Frequenzbereich von 0,5 MHz bis 5 MHz (IEC 61689:2013) This European Standard was approved by CENELEC on CENELEC 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 CENELEC 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 CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung Management Centre: Avenue Marnix 17, B Brussels 2013 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61689:2013 E

6 EN 61689: Foreword The text of document 87/522/FDIS, future edition 3 of IEC 61689, prepared by IEC TC 87 "Ultrasonics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 61689:2013. The following dates are fixed: latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement latest date by which the national standards conflicting with the document have to be withdrawn (dop) (dow) This document supersedes EN 61689:2007. EN 61689:2013 includes the following significant technical changes with respect to EN 61689:2007: restriction introduced of 0,2 W/cm 2 effective intensity during hydrophone measurements for treatment heads with ka 20, to limit the likelihood of cavitation; a change in the factor Fac, to determine the effective radiating area, from 1,354 to 1,333; change to SI units for terms and definitions; closer alignment and re-ordered, updated definitions in line with standards in EN series; minor arithmetical errors corrected in data analysis; inconsistencies and errors in symbol usage removed throughout; large number of editorial and formal corrections made; changes introduced to references in the bibliography. This standard should be read in conjunction with EN , which, as indicated in its preface, will itself be revised in order to be compatible with this standard. NOTE The following print types are used: Requirements: in Arial 10 point Notes: in Arial 8 point Words in bold in the text are defined in Clause 3 Symbols and formulae: Times New Roman + Italic Compliance clauses : in Arial Italic Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such patent rights. Endorsement notice The text of the International Standard IEC 61689:2013 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the standards indicated: IEC NOTE Harmonized as EN IEC NOTE Harmonized as EN IEC NOTE Harmonized as EN

7 - 3 - EN 61689:2013 Annex ZA (normative) Normative references to international publications with their corresponding European publications The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Publication Year Title EN/HD Year IEC Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN IEC Medical electrical equipment - Part 2-5: Particular requirements for the basic EN safety and essential performance of ultrasonic physiotherapy equipment IEC Ultrasonics - Power measurement - Radiation force balances and performance requirements IEC corr. August + A Ultrasonics - Hydrophones - Part 1: Measurement and characterization of medical ultrasonic fields up to 40 MHz EN EN A

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9 INTERNATIONAL STANDARD NORME INTERNATIONALE IEC Edition Ultrasonics Physiotherapy systems Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz Ultrasons Systèmes de physiothérapie Spécifications des champs et méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz IEC 61689:2013

10 THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2013 IEC, Geneva, Switzerland 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 IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie et les microfilms, sans l'accord écrit de la CEI ou du Comité national de la CEI du pays du demandeur. Si vous avez des questions sur le copyright de la CEI ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez les coordonnées ci-après ou contactez le Comité national de la CEI de votre pays de résidence. IEC Central Office Tel.: , rue de Varembé Fax: CH-1211 Geneva 20 info@iec.ch Switzerland About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technologies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Useful links: IEC publications search - The advanced search enables you to find IEC publications by a variety of criteria (reference number, text, technical committee, ). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published details all new publications released. Available on-line and also once a month by . Electropedia - The world's leading online dictionary of electronic and electrical terms containing more than terms and definitions in English and French, with equivalent terms in additional languages. Also known as the International Electrotechnical Vocabulary (IEV) on-line. Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csc@iec.ch. A propos de la CEI La Commission Electrotechnique Internationale (CEI) est la première organisation mondiale qui élabore et publie des Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées. A propos des publications CEI Le contenu technique des publications de la CEI est constamment revu. Veuillez vous assurer que vous possédez l édition la plus récente, un corrigendum ou amendement peut avoir été publié. Liens utiles: Recherche de publications CEI - La recherche avancée vous permet de trouver des publications CEI en utilisant différents critères (numéro de référence, texte, comité d études, ). Elle donne aussi des informations sur les projets et les publications remplacées ou retirées. Just Published CEI - webstore.iec.ch/justpublished Restez informé sur les nouvelles publications de la CEI. Just Published détaille les nouvelles publications parues. Disponible en ligne et aussi une fois par mois par . Electropedia - Le premier dictionnaire en ligne au monde de termes électroniques et électriques. Il contient plus de termes et définitions en anglais et en français, ainsi que les termes équivalents dans les langues additionnelles. Egalement appelé Vocabulaire Electrotechnique International (VEI) en ligne. Service Clients - webstore.iec.ch/csc Si vous désirez nous donner des commentaires sur cette publication ou si vous avez des questions contactez-nous: csc@iec.ch.

11 INTERNATIONAL STANDARD NORME INTERNATIONALE IEC Edition Ultrasonics Physiotherapy systems Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz Ultrasons Systèmes de physiothérapie Spécifications des champs et méthodes de mesure dans la gamme de fréquences de 0,5 MHz à 5 MHz INTERNATIONAL ELECTROTECHNICAL COMMISSION COMMISSION ELECTROTECHNIQUE INTERNATIONALE PRICE CODE CODE PRIX XB ICS ISBN Warning! Make sure that you obtained this publication from an authorized distributor. Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé. Registered trademark of the International Electrotechnical Commission Marque déposée de la Commission Electrotechnique Internationale

12 IEC:2013 CONTENTS FOREWORD... 4 INTRODUCTION Scope Normative references Terms and definitions List of symbols Ultrasonic field specifications Conditions of measurement and test equipment used General Test vessel Hydrophone rms or peak signal measurement Type testing reference procedures and measurements General Rated output power Hydrophone measurements Effective radiating area Reference type testing parameters Acceptance criteria for reference type testing Routine measurement procedure General Rated output power Effective radiating area Beam non-uniformity ratio Effective intensity Acceptance criteria for routine testing Sampling and uncertainty determination Reference type testing measurements Routine measurements Uncertainty determination Annex A (informative) Guidance for performance and safety Annex B (normative) Raster scan measurement and analysis procedures Annex C (normative) Diametrical or line scan measurement and analysis procedures Annex D (informative) Rationale concerning the beam cross-sectional area definition Annex E (informative) Factor used to convert the beam cross-sectional area (A BCS ) at the face of the treatment head to the effective radiating area (A ER ) Annex F (informative) Determining acoustic power through radiation force measurements Annex G (informative) Validity of low-power measurements of the beam crosssectional area (A BCS ) Annex H (informative) Influence of hydrophone effective diameter Annex I (informative) Effective radiating area measurement using a radiation force balance and absorbing apertures... 48

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