BS-EN-60601-2-37-2008.pdf
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1、BRITISH STANDARD BS EN 60601-2-37:2008 Medical electrical equipment Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment ICS 11.040.55; 17.140.50 ? Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, U
2、ncontrolled Copy, (c) BSI BS EN 60601-2-37:2008 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2008 BSI 2008 ISBN 978 0 580 55851 1 National foreword This British Standard is the UK implementation of EN 60601-2-37:2008. It is identic
3、al to IEC 60601-2-37:2007. It supersedes BS EN 60601-2-37:2001 which The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/2, Diagnostic imaging equipment. A list of organizations represented on this co
4、mmittee can be obtained on request to its secretary. 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/corrigenda iss
5、ued since publication DateComments will be withdrawn on 1 October 2010. Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD EN 60601-2-37 NORME EUROPENNE EUROPISCHE NORM January 2008 CENELEC European Committee for Electrotechnical Standardizat
6、ion Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Brussels 2008 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-37:2008 E
7、 ICS 11.040.55; 17.140.50 Supersedes EN 60601-2-37:2001 + A1:2005 + A2:2005 English version Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (IEC 60601-2-37:2007) Appareils lectr
8、omdicaux - Partie 2-37: Exigences particulires pour la scurit de base et les performances essentielles des appareils de diagnostic et de surveillance mdicaux ultrasons (CEI 60601-2-37:2007) Medizinische elektrische Gerte - Teil 2-37: Besondere Festlegungen fr die Sicherheit einschlielich der wesentl
9、ichen Leistungsmerkmale von Ultraschallgerten fr die medizinische Diagnose und berwachung (IEC 60601-2-37:2007) 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 E
10、uropean 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 Central Secretariat or to any CENELEC member. This European Standard exists in three official versions (
11、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 Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austr
12、ia, Belgium, Bulgaria, Cyprus, 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. Li
13、censed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI Foreword The text of document 62B/624/CDV, future edition 2 of IEC 60601-2-37, prepared by SC 62B, Diagnostic imaging equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-C
14、ENELEC parallel Unique Acceptance Procedure and was approved by CENELEC as EN 60601-2-37 on 2007-10-01. This European Standard supersedes EN 60601-2-37:2001 + A1:2005 + A2:2005. EN 60601-2-37:2008 combines EN 60601-2-37:2001 + A1:2005 + A2:2005 into a form compatible with the parent EN 60601-1:2006.
15、 The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2008-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2010-10-01 This Euro
16、pean Standard has been prepared under a mandate given to CENELEC by the European Commission and the European Free Trade Association and covers essential requirements of EC Directive 93/42/EEC. See Annex ZZ. In this standard, the following print types are used: requirements and definitions: in roman
17、type; test specifications: in italic type; informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type; TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: IN SMA
18、LL CAPITALS. In referring to the structure of this standard, the term “clause” means one of the seventeen numbered divisions within the table of contents, inclusive of all subdivisions (e.g. Clause 7 includes Subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1,
19、 7.2 and 7.2.1 are all subclauses of Clause 7). References to clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within this standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a state
20、ment is true if any combination of the conditions is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb “shall” means that compliance with a requirement or a test is mandatory for
21、 compliance with this standard; “should” means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used to describe a permissible way to achieve compliance with a requirement or test. BS EN 60601-2-37:2008 2 Licensed CopyChines
22、e University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex AA. Annexes ZA and ZZ have been added by CENELEC. _
23、Endorsement notice The text of the International Standard IEC 60601-2-37:2007 was approved by CENELEC as a European Standard without any modification. _ BS EN 60601-2-37:2008 3 Licensed CopyChinese University of Hong Kong, 21/10/2008 03:42, Uncontrolled Copy, (c) BSI CONTENTS INTRODUCTION.5 201.1 Sc
24、ope, object and related standards .6 201.2 Normative references7 201.3 Terminology and definitions 7 201.4 General requirements .10 201.5 General requirements for testing ME EQUIPMENT11 201.6 Classification of ME EQUIPMENT and ME SYSTEMS11 201.7 ME EQUIPMENT identification, marking and documents11 2
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