BS-EN-61157-2007.pdf
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1、BRITISH STANDARD BS EN 61157:2007 Standard means for the reporting of the medical diagnostic ultrasonic equipment The European Standard EN 61157:2007 has the status of a British Standard ICS 11.040.55; 17.140.50 ? acoustic output of Licensed Copy: London South Bank University, London South Bank Univ
2、ersity, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI BS EN 61157:2007 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 December 2007 BSI 2007 ISBN 978 0 580 57378 1 National foreword This British Standard is the UK impleme
3、ntation of EN 61157:2007. It is identical to IEC 61157:2007. It supersedes BS EN 61157:1995 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee EPL/87, Ultrasonics. A list of organizations represented on this committee can be obtained on request to its se
4、cretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard cannot confer immunity from legal obligations. Amendments issued since publication Amd. No. DateComments Licensed Co
5、py: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 61157 NORME EUROPENNE EUROPISCHE NORM November 2007 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Elect
6、rotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2007 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 61157:2007 E ICS 11.040.50; 11.140.50 Supersedes EN 61157
7、:1994 English version Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment (IEC 61157:2007) Moyens normaliss pour la dclaration des missions acoustiques des appareils de diagnostic mdical ultrasons (CEI 61157:2007) Normverfahren fr die Angabe der akustis
8、chen Ausgangsgren von medizinischen Ultraschalldiagnostikgerten (IEC 61157:2007) This European Standard was approved by CENELEC on 2007-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of
9、a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (English, French, German). A ver
10、sion in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Cyprus,
11、the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Licensed Copy: London South Bank
12、University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI Foreword The text of document 87/356/CDV, future edition 2 of IEC 61157, prepared by IEC TC 87, Ultrasonics, was submitted to the IEC-CENELEC parallel Unique Acceptance Procedure and was approved
13、 by CENELEC as EN 61157 on 2007-10-01. This European Standard supersedes EN 61157:1994. The changes with respect to EN 61157:1994 are listed below: maintenance on this standard and the referenced standards EN 61161 and EN 62127-1; a clause on compliance has been added. The following dates were fixed
14、: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2008-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-10-01 NOTE The following print types are used:
15、 Requirements: in roman type Test specifications: in italic type Notes: in small roman type Words in bold in the text are defined in Clause 3. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 61157:2007 was approved by CENELEC as a European Standard
16、 without any modification. _ 2 EN 61157:2007 Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Uncontrolled Copy, (c) BSI CONTENTS 1 2 3 4 4.1 4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 5 5.1 5.2 5.3 6 7 Figure C.1 Schematic diagram showing the rel
17、ationship between the various defined surfaces and distances for a mechanical sector scanner with water stand-off Figure C.2 Schematic diagram showing the relationship between the various defined parameters and distances for a mechanical sector scanner during the Figure C.3 Schematic diagram showing
18、 various defined parameters associated with the distribution of the scan lines in a linear array scanner and mechanically- Figure C.4 Schematic diagram illustrating the peak-rarefactional acoustic pressure Table A.1 An example of reporting of the acoustic output of a 3,5 MHz scan-head for 3 EN 61157
19、:2007 INTRODUCTION.4 Scope.5 Normative references .5 Terms, definitions and symbols 5 Requirements.15 General.15 Requirements for the reporting of acoustic output information .16 Technical data sheets information format 16 Detailed operating mode data sheets information format .17 Background informa
20、tion.18 Diagnostic fields in the absence of scan-frame synchronization.19 Dataset for low acoustic output equipment.19 Compliance statement20 General.20 Maximum probable values.20 Sampling.20 Test methods .21 Presentation of results21 Annex A (normative) Presentation of acoustic output information.2
21、2 Annex B (informative) Reporting requirements for extensive systems 24 Annex C (informative) Rationale 25 Index of defined terms 29 Bibliography31 distance when applied to a patient26 measurement of acoustic output.26 scanned sector scanner27 during an acoustic pulse.28 Table 1 List of symbols 14 a
22、 phased-array sector scanner in accordance with this standard23 Annex ZA (normative) Normative references to international publications with their corresponding European publications.32 Licensed Copy: London South Bank University, London South Bank University, Thu Dec 20 02:34:44 GMT+00:00 2007, Unc
23、ontrolled Copy, (c) BSI INTRODUCTION This International Standard specifies a standard means and format for the reporting of the acoustic output of medical diagnostic ultrasonic equipment. The numerical values for reporting purposes represent the average values for the maximum output conditions for a
24、 given discrete- or combined-operating mode and are derived from measurements made in water. Intensity parameters are specified in this standard, but these are regarded as derived quantities that are meaningful only under certain assumptions related to the ultrasonic field being measured. 4 EN 61157
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