BS-EN-60601-2-50-2002 IEC-60601-2-50-2000.pdf
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1、BRITISH STANDARD BS EN 60601-2-50:2002 IEC 60601-2-50:2000 Medical electrical equipment Part 2-50: Particular requirements for the safety of infant phototherapy equipment The European Standard EN 60601-2-50:2002 has the status of a British Standard ICS 11.040.50 NO COPYING WITHOUT BSI PERMISSION EXC
2、EPT AS PERMITTED BY COPYRIGHT LAW Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:15:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 60601-2-50:2002 This British Standard, having been prepared under the direction of the Health and Environment Sector Policy and Strategy Committee, was p
3、ublished under the authority of the Standards Policy and Strategy Committee on 13 March 2002 BSI 13 March 2002 ISBN 0 580 36948 X National foreword This British Standard is the official English language version of EN 60601-2-50:2002. It is identical with IEC 60601-2-50:2000. The UK participation in
4、its preparation was entrusted to Technical Committee CH/91, Incubators, 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 IEC publications have the number 60000 added to the old number. For ins
5、tance, IEC 27 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 which implement these international or European publications may be fou
6、nd 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 does not purport to include all the necessary provisions of a contract. Users of British Standard
7、s 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 responsible European committee any enquiries on the interpretation, or proposals for change, and keep th
8、e 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 26, an inside back cover and a back cover. The BSI copyright date displayed in
9、this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:15:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARDEN 60601-2-50 NORME EUROPENNE EUROPISCHE NORMFebruary 2002
10、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 2002 CENELEC -All rights of exploitation in any form and by any means reserved w
11、orldwide for CENELEC members. Ref. No. EN 60601-2-50:2002 E ICS 11.040.60 English version Medical electrical equipment Part 2-50: Particular requirements for the safety of infant phototherapy equipment (IEC 60601-2-50:2000 + corrigendum March 2001) Appareils lectromdicaux Partie 2-50: Prescriptions
12、particulires de scurit des appareils de photothrapie infantile (CEI 60601-2-50:2000 + corrigendum mars 2001) Medizinische elektrische Gerte Teil 2-50: Besondere Festlegungen fr die Sicherheit von Suglings- Phototherapiegerten (IEC 60601-2-50:2000 + Corrigendum Mrz 2001) This European Standard was ap
13、proved by CENELEC on 2000-09-01. 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 bibliographical references concerning such na
14、tional 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 CENELEC member into its own langu
15、age and notified to the Central Secretariat has the same status as the official versions. CENELEC members are the national electrotechnical committees of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Port
16、ugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:15:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN 60601-2-50:2002- 2 - Foreword The text of document 62D/363/FDIS, future edition 1 of IEC 60601-2-50, prepared by SC 62D, Electromedical e
17、quipment, of IEC TC 62, Electrical equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved by CENELEC as EN 60601-2-50 on 2000-09-01. The following dates were fixed: latest date by which the EN has to be implemented at national level by publication of an identi
18、cal national standard or by endorsement(dop)2002-08-01 latest date by which the national standards conflicting with the EN have to be withdrawn(dow)2003-09-01 Annexes designated “normative“ are part of the body of the standard. Annexes designated “informative“ are given for information only. In this
19、 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: requirements, compliance with which can be tested, and definitions: roman type; notes, explanations, advice, introductions, gene
20、ral statements, exceptions and references: smaller roman type; test specifications: italic type; TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD EN 60601-1 OR THIS PARTICULAR STANDARD: SMALL CAPITALS. _ Endorsement notice The text of the International Standard IEC 60601-2-50:2000 was approved by C
21、ENELEC as a European Standard without any modification. _ Page 2 EN 60601250:2002 BSI 13 March 2002 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 08 03:15:53 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 60601-2-50 ? IEC:2000(E) 3 .Page INTRODUCTION 5 SECTION ONE GENERAL Clause 1Scope and object
22、. 6 1.1Scope. 6 1.2Object. 6 1.3Particular Standards . 6 1.5Collateral Standards . 7 *2Terminology and definitions 7 2.1EQUIPMENT parts, auxiliaries and ACCESSORIES 7 2.12Miscellaneous. 8 4General requirements for tests . 8 4.6Other conditions 8 5Classification . 9 6Identification, marking and docum
23、ents 9 6.1Marking on the outside of EQUIPMENT or EQUIPMENT parts 9 6.2Marking on the inside of EQUIPMENT or EQUIPMENT parts. 9 6.8ACCOMPANYING DOCUMENTS. 9 SECTION TWO ENVIRONMENTAL CONDITIONS SECTION THREE PROTECTION AGAINST ELECTRIC SHOCK HAZARDS SECTION FOUR PROTECTION AGAINST MECHANICAL HAZARDS
24、21Mechanical strength12 24Stability in NORMAL USE12 25Expelled parts.13 26Vibration and noise .13 SECTION FIVE PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION *32 Light radiation (including lasers)13 *33 Infrared radiation.13 *34 Ultraviolet radiation .14 36ELECTROMAGNETIC COMPATIBIL
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- BS-EN-60601-2-50-2002 IEC-60601-2-50-2000 BS EN 60601 50 2002 IEC 2000
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