BS-EN-60601-2-47-2001 IEC-60601-2-47-2001.pdf
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1、BRITISH STANDARD BS EN 60601-2-47: 2001 IEC 60601-2-47: 2001 Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems The European Standard EN 60601-2-47:2001 has the status of a British Standard ICS 1
2、1.040.55 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:09:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-47:2001 This British Standard, having been prepared under the direction of the Health and Environme
3、nt Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 27 November 2001 BSI 27 November 2001 ISBN 0 580 38712 7 National foreword This British Standard is the official English language version of EN 60601-2-47:2001. It is identica
4、l with IEC 60601-2-47:2001. The UK participation in its preparation was entrusted to Technical Committee CH/96, Patient Monitoring Equipment, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. From 1 January 1997, all I
5、EC publications have the number 60000 added to the old number. For instance, IEC 27-1 has been renumbered as IEC 60027-1. For a period of time during the change over from one numbering system to the other, publications may contain identifiers from both systems. Cross-references The British Standards
6、 which implement international or European publications referred to in this document 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. A British Standard do
7、es 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 immunity from legal obligations. aid enquirers to understand the text; present to the responsib
8、le international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover,
9、the EN title page, pages 2 to 45, and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:09:40 GMT+00:00 2006, Uncontrolled Co
10、py, (c) BSI EUROPEAN STANDARDEN 60601-2-47 NORME EUROPENNE EUROPISCHE NORMOctober 2001 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: rue de Stassart 35, B - 1050 Br
11、ussels 2001 CENELEC -All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-47:2001 E ICS 11.040.55 English version Medical electrical equipment Part 2-47: Particular requirements for the safety, including essential performance, of ambulat
12、ory electrocardiographic systems (IEC 60601-2-47:2001) Appareils lectromdicaux Partie 2-47: Rgles particulires de scurit et performances essentielles des systmes dlectrocardiographie ambulatoires (CEI 60601-2-47:2001) Medizinische elektrische Gerte Teil 2-47: Besondere Festlegungen fr die Sicherheit
13、 einschlielich wesentlicher Leistungsmerkmale von ambulanten elektrokardiographischen Systemen (IEC 60601-2-47:2001) This European Standard was approved by CENELEC on 2001-10-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving t
14、his 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 Central Secretariat or to any CENELEC member. This European Standard exists in three official versi
15、ons (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
16、Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:09:40 GMT+00:00 2006, Uncontrolled Copy, (c
17、) BSI Foreword The text of document 62D/408/FDIS, future edition 1 of IEC 60601-2-47, prepared by SC 62D, Electromedical equipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-47 on 2001-10-01. The f
18、ollowing 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)2002-07-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow)2004-10-01 Annexes designated
19、“normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this standard, annex ZA is normative and annexes AA and ZB are informative. Annexes ZA and ZB have been added by CENELEC. In this standard, the following print types are used: requir
20、ements, compliance with which can be tested, and definitions: roman type; explanations, advice, notes, general statements and exceptions: smaller roman type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR THIS PARTICULAR STANDARD: SMALL CAPITALS. _ Endorsement
21、 notice The text of the International Standard IEC 60601-2-47:2001 was approved by CENELEC as a European Standard without any modification. _ Page 2 EN 60601247:2001 BSI 27 November 2001 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:09:40 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 60601-
22、2-47 IEC:2001(E) 3 CONTENTS INTRODUCTION 5 SECTION ONE GENERAL 1 Scope and object. 6 2 Terminology and definitions . 7 5 Classification 9 6 Identification, marking and documents . 9 SECTION TWO ENVIRONMENTAL CONDITIONS 10 Environmental conditions10 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZ
23、ARDS 20 Dielectric strength.11 SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS 21 Mechanical strength11 SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 36 Electromagnetic compatibility12 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTU
24、RES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data .14 51 Protection against hazardous output .21 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENV
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