07-30173584-DC.pdf

a Date: 12 November 2007 Origin: International Latest date for receipt of comments: 29 February 2008 Project no.: 2007/02965 Responsible committee: EPL/29 Electroacoustics Interested committees: Title: Draft BS EN 60645-7 ED.1 Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of audiotory evoked potentials Supersession information: If this document is published as a standard, the UK implementation of it will supersede NONE and partially supersede. NONE If you are aware of a current national standard which may be affected, please notify the secretary (contact details below). WARNING: THIS IS A DRAFT AND MUST NOT BE REGARDED OR USED AS A BRITISH STANDARD. THIS DRAFT IS NOT CURRENT BEYOND 29 February 2008. This draft is issued to allow comments from interested parties; all comments will be given consideration prior to publication. No acknowledgement will normally be sent. See overleaf for information on commenting. No copying is allowed, in any form, without prior written permission from BSI except as permitted under the Copyright, Designs and Patent Act 1988 or for circulation within a nominating organization for briefing purposes. Electronic circulation is limited to dissemination by e-mail within such an organization by committee members. Further copies of this draft may be purchased from BSI Customer Services, Tel: +44(0) 20 8996 9001 or email ordersbsi-global.com. British, International and foreign standards are also available from BSI Customer Services. Information on the co-operating organizations represented on the committees referenced above may be obtained from the responsible committee secretary. Cross-references The British Standards which implement International or European publications referred to in this draft may be found via the British Standards Online Service on the BSI web site http:/www.bsi-global.com. Direct tel: 020 8996 7205 Responsible Committee Secretary: Mr A Ashrafi (BSI) E-mail: asghar.ashrafibsi-global.com Draft for Public Comment Head Office 389 Chiswick High Road London W4 4AL Telephone: +44(0)20 8996 9000 Fax: +44(0)20 8996 7001 Form 36 Version 7.0 DPC: 07/30173584 DC Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI b Introduction This draft standard is based on international discussions in which the UK has taken an active part. Your comments on this draft are welcome and will assist in the preparation of the consequent standard. If no comments are received to the contrary, then the UK will approve this draft. There is a high probability that this text could be adopted by CENELEC as a reference document for harmonization or as a European Standard. Recipients of this draft are requested to comment on the text bearing in mind this possibility. UK Vote Please indicate whether you consider the UK should submit a negative (with reasons) or positive vote on this draft. Submission The guidance given below is intended to ensure that all comments receive efficient and appropriate attention by the responsible BSI committee. Annotated drafts are not acceptable and will be rejected. All comments must be submitted, preferably electronically, to the Responsible Committee Secretary at the address given on the front cover. Comments should be compatible with Version 6.0 or Version 97 of Microsoft® Word for Windows, if possible; otherwise comments in ASCII text format are acceptable. Any comments not submitted electronically should still adhere to these format requirements. All comments submitted should be presented as given in the example below. Further information on submitting comments and how to obtain a blank electronic version of a comment form are available from the BSI web site at: http:/www.bsi-global.com/en/Standards-and-Publications/Current-work/DPCs/ Template for comments and secretariat observations Date: xx/xx/200x Document: ISO/DIS xxxxx 1 2 (3) 4 5 (6) (7) MB Clause No./ Subclause No./ Annex (e.g. 3.1) Paragraph/ Figure/Table/ Note (e.g. Table 1) Type of com- ment Comment (justification for change) by the MB Proposed change by the MB Secretariat observations on each comment submitted 3.1 Definition 1 ed Definition is ambiguous and needs clarifying. Amend to read . so that the mains connector to which no connection . 6.4 Paragraph 2 te The use of the UV photometer as an alternative cannot be supported as serious problems have been encountered in its use in the UK. Delete reference to UV photometer. Microsoft and MS-DOS are registered trademarks, and Windows is a trademark of Microsoft Corporation. Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI FORM CDV (IEC) 2005-09-23 29/636/CDV COMMITTEE DRAFT FOR VOTE (CDV) PROJET DE COMITÉ POUR VOTE (CDV) Project number IEC 60645-7 Ed.1 Numéro de projet IEC/TC or SC: 29 CEI/CE ou SC: Secretariat / Secrétariat Denmark Submitted for parallel voting in CENELEC Soumis au vote parallèle au CENELEC Date of circulation Date de diffusion 2007-11-02 Closing date for voting (Voting mandatory for P-members) Date de clôture du vote (Vote obligatoire pour les membres (P) 2008-04-04 Also of interest to the following committees Intéresse également les comités suivants Supersedes document Remplace le document 29/622/NP, 29/630/RVN Functions concerned Fonctions concernées Safety Sécurité EMC CEM Environment Environnement Quality assurance Assurance qualité CE DOCUMENT EST TOUJOURS À L'ÉTUDE ET SUSCEPTIBLE DE MODIFICATION. IL NE PEUT SERVIR DE RÉFÉRENCE. LES RÉCIPIENDAIRES DU PRÉSENT DOCUMENT SONT INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS, LA NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À FOURNIR UNE DOCUMENTATION EXPLICATIVE. THIS DOCUMENT IS STILL UNDER STUDY AND SUBJECT TO CHANGE. IT SHOULD NOT BE USED FOR REFERENCE PURPOSES. 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. Titre : :CEI 60645-7 Ed.1 : Electroacoustique - Appareillage audiométrique - Partie 7: Instruments pour la mesure des potentiels évoqués auditifs Title : IEC 60645-7 Ed.1: Electroacoustics - Audiometric equipment - Part 7: Instruments for the measurement of auditory evoked potentials Note d'introduction Introductory note A NWIP for the inclusion of a part 7 in the IEC 60645-series, doc. 29/620/NP, was circulated for voting by 2007-03-16. A first CD was included with the NWIP. The item was approved as given in doc. 29/630/RVN and allocated to IEC/TC 29/WG 10 “Audiometric equipment“. Based on the comments on the new proposal/first CD, WG 10 has prepared the present document, which is now circulated as a CDV. ATTENTION VOTE PARALLÈLE CEI CENELEC Lattention des Comités nationaux de la CEI, membres du CENELEC, est attirée sur le fait que ce projet de comité pour vote (CDV) de Norme internationale est soumis au vote parallèle. Un bulletin de vote séparé pour le vote CENELEC leur sera envoyé par le Secrétariat Central du CENELEC. ATTENTION IEC CENELEC PARALLEL VOTING The attention of IEC National Committees, members of CENELEC, is drawn to the fact that this Committee Draft for Vote (CDV) for an International Standard is submitted for parallel voting. A separate form for CENELEC voting will be sent to them by the CENELEC Central Secretariat. Copyright © 2007 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You may not copy or “mirror“ the file or printed version of the document, or any part of it, for any other purpose without permission in writing from IEC. Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 60645-7Ed.1/CDV © IEC:2007 2 CONTENTS FOREWORD.3 INTRODUCTION.5 1 Scope.6 2 Normative references .6 3 Terms and definitions .7 4 Requirements for specific instruments 7 5 General specifications 8 6 Demonstration of conformity with specifications10 7 General requirements.11 Bibliography13 Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 60645-7Ed.1/CDV © IEC:2007 3 ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 7: Instruments for the measurement of auditory evoked potentials FOREWORD 1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, the IEC publishes International Standards. Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested National Committees. 3) The documents produced have the form of recommendations for international use and are published in the form of standards, technical specifications, technical reports or guides and they are accepted by the National Committees in that sense. 4) In order to promote international unification, IEC National Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. 5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. 6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights. International Standard IEC 60645-7 has been prepared by IEC technical committee 29: Electroacoustics. The text of this standard is based on the following documents: FDIS Report on voting XX/XX/FDIS XX/XX/RVD Full information on the voting for the approval of this standard can be found in the report on voting indicated in the above table. This publication has been drafted in accordance with the ISO/IEC Directives, Part 2. Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 60645-7Ed.1/CDV © IEC:2007 4 IEC 60645 consists of the following parts: Part 1: Pure-tone audiometers Part 2: Equipment for speech audiometry Part 3: Test signals of short duration Part 4: Equipment for extended high-frequency audiometry Part 5: Instruments for the measurement of aural acoustic impedance/admittance1 The committee has decided that the contents of this publication will remain unchanged until the maintenance result date2) indicated on the IEC web site under “http:/webstore.iec.ch“ in the data related to the specific publication. At this date, the publication will be reconfirmed; withdrawn; replaced by a revised edition, or amended. 1 Future editions of all parts of this series will appear under the new general title Electroacoustics Audiometric equipment. 2) The National Committees are requested to note that for this publication the maintenance result date is 2010 Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 60645-7Ed.1/CDV © IEC:2007 5 INTRODUCTION Developments in the field of diagnostic hearing measurement have resulted in a number of instruments designed to evaluate the auditory evoked potentials of the human hearing system which can be evoked by acoustic or electric probe signals having different spectral and temporal characteristics. The practical use of such instruments concerns the measurement of these electric potentials and their separation from electric signals emerging from other physiological or artificial sources. Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:42:30 GMT+00:00 2007, Uncontrolled Copy, (c) BSI 60645-7Ed.1/CDV © IEC:2007 6 ELECTROACOUSTICS AUDIOMETRIC EQUIPMENT Part 7: Instruments for the measurement of auditory evoked potentials 1 Scope This part of IEC 60645 applies to instruments designed primarily for the measurement of auditory evoked potentials in the inner ear, the auditory nerve and the brainstem, evoked by acoustic and/or vibratory force stimuli of short duration. The standard defines the characteristics to be specified by the manufacturer, lays down performance specifications for two types of instruments,screening and full diagnostics, and specifies the functions to be provided on these types. The purpose of this standard is to ensure that measurements made under comparable test conditions with different instruments complying with the standard will be consistent. The standard is not intended to restrict development or incorporation of new features, nor to discourage innovative approaches. The application of electric stimuli for special purposes is beyond the scope of this standard. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IEC 60318-1, Electroacoustics Simulators of human head and ear Part 1: Ear simulator for the calibration of supra-aural earphones” (Revision of IEC 318:1970) IEC 60318-3, Electroacoustics Simulators of human head and ear Part 3: Acoustic coupler for the calibration of supra-aural earphones used in audiometry IEC 60318-4, Electroacoustics Simulators of human head and ear Part 4: Occluded-ear simulator for the measurement of earphones coupled to the ear by ear inserts (Revision of IEC 60711:1981) 3 IEC 60318-5, Electroacoustics Simulators of human head and ear Part 5: 2 cm3 coupler for the measurement of hearing aids and earphon