BS EN 60601-2-19-2009 医疗电气设备.婴儿保温箱基本安全和主要性能的特殊要求1.pdf
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1、- - - - - - - - Medical electrical equipment Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators BS EN 60601-2-19:2009 National foreword This British Standard is the UK implementation of EN 60601-2-19:2009. It is identical to IEC 60601-2-19:2009. It
2、 supersedes BS EN 60601-2-19:1997, which will be withdrawn on 1 April 2012. The UK participation in its preparation was entrusted by Technical Committee CH/62, Electromedical equipment in medical practice, to Subcommittee CH/62/4, Electromedical equipment. A list of organizations represented on this
3、 committee 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. BSI 2009 ISBN 978 0 580 57521 1 ICS 11.040.10 Compliance with a British Standard cannot confer immunity
4、from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 July 2009 Amendments issued since publication Amd. No. Date Text affected BRITISH STANDARDBS EN 60601-2-19:2009 EUROPEAN STANDARD EN 60601-2-19 NORME EUROPENNE EUROPIS
5、CHE NORM May 2009 CENELEC European Committee for Electrotechnical Standardization Comit Europen de Normalisation Electrotechnique Europisches Komitee fr Elektrotechnische Normung Central Secretariat: Avenue Marnix 17, B - 1000 Brussels 2009 CENELEC - All rights of exploitation in any form and by any
6、 means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-19:2009 E ICS 11.040.10 Supersedes EN 60601-2-19:1996 + A1:1996 English version Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (IEC 60601-2-19:200
7、9) Appareils lectromdicaux - Partie 2-19: Exigences particulires pour la scurit de base et les performances essentielles des incubateurs pour nouveau-ns (CEI 60601-2-19:2009) Medizinische elektrische Gerte - Teil 2-19: Besondere Festlegungen fr die Sicherheit einschlielich der wesentlichen Leistungs
8、merkmale von Suglingsinkubatoren (IEC 60601-2-19:2009) This European Standard was approved by CENELEC on 2009-04-01. 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 withou
9、t 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 (English, French, German). A version in any other language
10、 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 Austria, Belgium, Bulgaria, Cyprus, the Czech Republic, Denmar
11、k, 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. BS EN 60601-2-19:2009 EN 60601-2-19:2009 - 2 - Foreword The
12、 text of document 62D/727/FDIS, future edition 2 of IEC 60601-2-19, 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 60601-2-19 on 2009-04-01. This European Standard
13、supersedes EN 60601-2-19:1996 + A1:1996. EN 60601-2-19:1996 was revised to structurally align with EN 60601-1:2006. 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) 2010-01-01
14、latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-04-01 This European 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 MDD
15、 (93/42/EEC). See Annex ZZ. In this standard, the following print types are used: Requirements and definitions: roman type. Test specifications: italic type. Informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in
16、 a smaller type. TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL 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.
17、g. Clause 7 includes subclauses 7.1, 7.2, etc.); “subclause” means a numbered subdivision of a clause (e.g. 7.1, 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
18、this particular standard are by number only. In this standard, the conjunctive “or” is used as an “inclusive or” so a statement 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 th
19、e purposes of this standard, the auxiliary verb: “shall” means that compliance with a requirement or a test is mandatory for 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
20、 to describe a permissible way to achieve compliance with a requirement or test. 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. BS EN 60601-2-19:2009 - 3 - EN 60601-2-
21、19:2009 Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-19:2009 was approved by CENELEC as a European Standard without any modification. In the official version, for Bibliography, the following notes have to be added for the stand
22、ards indicated: IEC 60601-2-21 NOTE Harmonized as EN 60601-2-21:2009 (not modified). IEC 60601-2-50 NOTE Harmonized as EN 60601-2-50:2009 (not modified). IEC 61672-1 NOTE Harmonized as EN 61672-1:2003 (not modified). _ BS EN 60601-2-19:2009 EN 60601-2-19:2009 - 4 - Annex ZA (normative) Normative ref
23、erences to international publications with their corresponding European publications The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document
24、(including any amendments) applies. NOTE When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD applies. Annex ZA of EN 60601-1:2006 applies, except as follows: Publication Year Title EN/HD Year Replace the reference to IEC 60601-1-2 by: I
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