BS-EN-60601-2-17-2004.pdf
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1、BRITISH STANDARD BS EN 60601-2-17:2004 Medical electrical equipment Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment The European Standard EN 60601-2-17:2004 has the status of a British Standard ICS 11.040.60; 19.100 ? Licensed Copy:
2、sheffieldun sheffieldun, na, Thu Nov 09 01:05:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-17:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on 26 April 2004 BSI 26 April 2004 ISBN 0 580 43666 7 National foreword This Britis
3、h Standard is the official English language version of EN 60601-2-17:2004. It is identical with IEC 60601-2-17:2004. It supersedes BS EN 60601-2-17:1996 which is withdrawn. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practic
4、e, to Subcommittee CH/62/3, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, which has the responsibility to: A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references The British Standards which implement internationa
5、l or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to
6、include all the necessary provisions of a contract. Users are responsible for its 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 responsible international/European committee any e
7、nquiries 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, the EN title page, pages 2 to 32, inside
8、back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN
9、STANDARD EN 60601-2-17 NORME EUROPENNE EUROPISCHE NORM April 2004 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 2004 CENELEC -
10、 All rights of exploitation in any form and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-17:2004 E ICS 11.040.60; 19.100 Supersedes EN 60601-2-17:1996 + A1:1996 English version Medical electrical equipment Part 2-17: Particular requirements for the safety of automatically
11、-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004) Appareils lectromdicaux Partie 2-17: Rgles particulires de scurit des appareils projecteurs de brachythrapie avec contrles automatiques (CEI 60601-2-17:2004) Medizinische elektrische Gerte Teil 2-17: Besondere Festlegungen fr die
12、 Sicherheit ferngesteuerter, automatisch betriebener Afterloading-Gerte fr die Brachytherapie (IEC 60601-2-17:2004) This European Standard was approved by CENELEC on 2004-03-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving th
13、is 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 versio
14、ns (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 A
15、ustria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sh
16、effieldun, na, Thu Nov 09 01:05:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Foreword The text of document 62C/363/FDIS, future edition 2 of IEC 60601-2-17, prepared by SC 62C, Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical equipment in medical practi
17、ce, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-17 on 2004-03-01. This European Standard supersedes EN 60601-2-17:1996 + A1:1996. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an iden
18、tical national standard or by endorsement (dop) 2004-12-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2007-03-01 In this standard, the following print types are used: requirements, compliance with which can be tested, and definitions: roman type; e
19、xplanations, advice, notes, general statements, exceptions and references: small roman type; test specifications: italic type; TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH ARE DEFINED IN CLAUSE 2 OR IN THE GENERAL STANDARD EN 60601-1, ITS COLLATERAL OR PART 2 STANDARDS, OR IN IEC 60788: SMAL
20、L CAPITALS. Annex ZA has been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-17:2004 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following note has to be added for the standard indi
21、cated: IEC 60601-1-3 NOTE Harmonized as EN 60601-1-3:1994 (not modified). _ Page 2 EN 60601217:2004 Licensed Copy: sheffieldun sheffieldun, na, Thu Nov 09 01:05:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI CONTENTS INTRODUCTION.4 SECTION ONE GENERAL 1 Scope and object5 2 Terminology and definitions
22、 7 4 General requirements for tests9 5 Classification9 6 Identification, marking and documents 10 SECTION TWO ENVIRONMENTAL CONDITIONS 10 Environmental conditions 14 SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS. SECTION FIVE PROTECTION AG
23、AINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 29 X-radiation14 30 Alpha, beta, gamma, NEUTRON RADIATION and other particle radiation .14 SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVEN PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY
24、HAZARDS SECTION EIGHT ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50 Accuracy of operating data24 SECTION NINE ABNORMAL OPERATION AND FAULT CONDITIONS; ENVIRONMENTAL TESTS 52 Abnormal operation and fault conditions27 SECTION TEN CONSTRUCTIONAL REQUIREMENTS Appendix L (normativ
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