BS-EN-60601-1-4-1997 BS-5724-1.4-1997 IEC-60601-1-4-1996.pdf
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1、BRITISH STANDARD BS EN 60601-1-4:1997 BS 5724-1.4: 1997 IEC 60601-1-4: 1996 Incorporating Amendment No. 1Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems The European Standard EN 60601-1-4:1996 with the incorporation
2、of amendment A1:1999 has the status of a British Standard ICS 11.040.01 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-1-4:1997 This British Standard, having
3、 been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 June 1997 BSI 04-2001 The following BSI references relate to the work on this standard: Committee reference CH/64 Draft for comment 94/5
4、05432 DC ISBN 0 580 27461 6 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/64, Safety, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of X-ray E
5、quipment Manufacturers (BEAMA Ltd.) British Dental Trade Association British Photographic Association BSI Testing Services College of Radiographers Department of Health GAMBICA (BEAMA Ltd.) Health and Safety Executive Institute of Physics and Engineering in Medicine and Biology Institution of Electr
6、ical Engineers Medical Sterile Products Association Royal College of Radiologists SIRA Limited Amendments issued since publication Amd. No.DateComments 13000April 2001Indicated by a sideline Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS
7、 EN 60601-1-4:1997 BSI 04-2001 i Contents Page Committees responsible Inside front cover National foreword ii Foreword2 Text of EN 60601-1-44 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-1-4:1997 ii BSI 04-2001 National forewo
8、rd This British Standard has been prepared by Technical Committee CH/64. It is the English language version of EN 60601-1-4:1996 Medical electrical equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems including amendment A1:1999, published
9、by the European Committee for Electrotechnical Standardization (CENELEC). It is identical with IEC 601-1-4:1996 including amendment 1:1999, published by the International Electrotechnical Commission (IEC). The requirements of this Collateral Standard are in addition to those of BS 5724-1:1989 herein
10、after called the General Standard. As in the General Standard, the requirements are followed by compliance tests. The numbers of the sections and clauses in this standard refer to the related sections and clauses in the General Standard. Clauses, subclauses or figures that are additional to those of
11、 the General Standard are numbered starting from 201; additional annexes are lettered AAA, BBB, etc. A rationale for the most important requirements is given in Annex BBB. It is considered that a knowledge of the reasons for the requirements will not only facilitate the proper application of the sta
12、ndard, but will expedite any subsequent revision. This annex does not form a normative part of the standard. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their correspondin
13、g European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue
14、. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Additional information. The following print types are used in this standard. Requirements, with which compliance can be tested, and d
15、efinitions: in roman type. Explanations, advice, general statements, exceptions and references: in small roman type. Test procedures: in italic type. Terms defined in clause 2 of BS 5724-1 or of BS EN 60601-1-1 or of this standard or in BS 6641: SMALL CAPITALS. For the purposes of this British Stand
16、ard, any references to IEC page numbers in the text should be ignored. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer imm
17、unity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 27 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Sidelining in this document
18、 indicates the most recent changes by amendment. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:05:16 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 60601-1-4 September 1996 +A1 December 1999 ICS 11.040.00 English version Medical electrical
19、 equipment Part 1-4: General requirements for safety Collateral standard: Programmable electrical medical systems (includes amendment A1:1999) (IEC 60601-1-4:1996 + A1:1999) Appareils lectromdicaux Partie 1-4: Rgles gnrales de scurit Norme collatrale: Systmes lectromdicaux programmables (inclut lame
20、ndement A1:1999) (CEI 60601-1-4:1996 + A1:1999) Medizinische elektrische Gerte Teil 1-4: Allgemeine Festlegungen fr die Sicherheit Ergnzungsnorm: Programmierbare, elektrische, medizinische Systeme (enthlt nderung A1:1999) (IEC 60601-1-4:1996 + A1:1999) This European Standard was approved by CENELEC
21、on 1996-07-02. Amendment A1 was approved by CENELEC on 1999-12-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliograph
22、ical-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 version in any other language made by translation under the responsibility of a
23、 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, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, N
24、orway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B-1050 Brussels 1996 Copyright res
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