BS EN 60601-2-50-2009 医用电气设备.婴儿光疗设备基本安全和基本性能的特殊要求.pdf
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1、- - - - - - - - Medical electrical equipment Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment BS EN 60601-2-50: 2009 National foreword This British Standard is the UK implementation of EN 60601-2-50:2009. It is identical to IEC 60601-
2、2-50:2009. It supersedes BS EN 60601-2-50:2002, which will be withdrawn on 1 May 2012.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 represen
3、ted on this 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 57241 8 ICS 11.040.60 Compliance with a British Standard cannot confe
4、r immunity 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 60601-2-50:2009 EUROPEAN STANDARD EN 60601-2-50 NORME EUROPE
5、NNE EUROPISCHE 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
6、 and by any means reserved worldwide for CENELEC members. Ref. No. EN 60601-2-50:2009 E ICS 11.040.60 Supersedes EN 60601-2-50:2002 English version Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment (IEC 6
7、0601-2-50:2009) Appareils lectromdicaux - Partie 2-50: Exigences particulires pour la scurit de base et les performances essentielles des appareils de photothrapie pour nouveau-ns (CEI 60601-2-50:2009) Medizinische elektrische Gerte - Teil 2-50: Besondere Festlegungen fr die Sicherheit einschlielich
8、 der wesentlichen Leistungsmerkmale von Suglings-Phototherapiegerten (IEC 60601-2-50:2009) This European Standard was approved by CENELEC on 2009-05-01. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the
9、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 versions (English, French, Germ
10、an). 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 Austria, Belgium, Bulgaria
11、, Cyprus, the Czech Republic, Denmark, 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 60601-2-50:2009 E
12、N 60601-2-50:2009 - 2 - Foreword The text of document 62D/736A/FDIS, future edition 2 of IEC 60601-2-50, 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 60601-2-50 o
13、n 2009-05-01. This European Standard supersedes EN 60601-2-50:2002. Specific technical changes from EN 60601-2-50:2002 include: requiring graphical representation of the spectral irradiance in the instructions for use (this was previously optional; see 201.7.9.2.5 b); requirements for support and mo
14、unting brackets for ACCESSORIES (see 201.9.8.101); requiring restoration of any preset values upon interruption and restoration of the power supply, if applicable (see 201.11.8); and corrections to the first four exposure limits (ELs) listed in Table AA.1. Minor changes from EN 60601-2-50:2002 inclu
15、de replacing the figure containing the eye protection symbol with a reference to this same symbol in IEC 60878 (see 201.7.2.101), defining an INFANT (see 201.3.202) and clarifying the titles for subclauses 201.5.4.102 and 201.5.4.103. The main purpose, however, is to provide consistency with the gen
16、eral standard EN 60601-1:2006. This EN 60601-2-50:2009 further provides consistency with the four other particular standards related to pediatric equipment for which the committee is responsible. The following dates were fixed: latest date by which the EN has to be implemented at national level by p
17、ublication of an identical national standard or by endorsement (dop) 2010-02-01 latest date by which the national standards conflicting with the EN have to be withdrawn (dow) 2012-05-01 This European Standard has been prepared under a mandate given to CENELEC by the European Commission and the Europ
18、ean Free Trade Association and covers essential requirements of EC Directive MDD (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 note
19、s, examples and references: in smaller type. Normative text of tables is also in 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 nu
20、mbered divisions within the table of contents, inclusive of all subdivisions (e.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). BS EN 60601-2-50:2009 - 3 - EN 60601-2-50:2009 References to
21、 clauses within this standard are preceded by the term “Clause” followed by the clause number. References to subclauses within 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
22、is true. The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC Directives, Part 2. For the 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 th
23、at compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard; “may” is used 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 tabl
24、e title indicates that there is guidance or rationale related to that item in Annex AA. Annexes ZA and ZZ have been added by CENELEC. _ Endorsement notice The text of the International Standard IEC 60601-2-50:2009 was approved by CENELEC as a European Standard without any modification. In the offici
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- BS EN 60601-2-50-2009 医用电气设备.婴儿光疗设备基本安全和基本性能的特殊要求 60601 50 2009 医用 电气设备 婴儿 光疗 设备 基本 安全 性能 特殊要求
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