BS EN ISO 10651-4-2009 Lung ventilators - Part 4 Particular requirements for operator-powered resuscitators (ISO 10651-4 2002)《肺换气机 第4部分 对操作人员控制的复苏器的详细要求(ISO 10651-4-2002)》.pdf
《BS EN ISO 10651-4-2009 Lung ventilators - Part 4 Particular requirements for operator-powered resuscitators (ISO 10651-4 2002)《肺换气机 第4部分 对操作人员控制的复苏器的详细要求(ISO 10651-4-2002)》.pdf》由会员分享,可在线阅读,更多相关《BS EN ISO 10651-4-2009 Lung ventilators - Part 4 Particular requirements for operator-powered resuscitators (ISO 10651-4 2002)《肺换气机 第4部分 对操作人员控制的复苏器的详细要求(ISO 10651-4-2002)》.pdf(34页珍藏版)》请在麦多课文档分享上搜索。
1、BS EN ISO10651-4:2009ICS 11.040.10,NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDLung ventilatorsPart 4: Particular requirements foroperator-powered resuscitators (ISO10651-4:2002)This British Standardwas published under theauthority of the StandardsPolicy and
2、 StrategyCommittee on 30 June2009. BSI 2009ISBN 978 0 580 65558 6Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10651-4:2009National forewordThis British Standard is the UK implementation of EN ISO10651-4:2009. It is identical to ISO 10651-4:2002. It supersedes BS ENISO 10651-4
3、:2002 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to i
4、nclude all the necessary provisionsof a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARDNORME EUROPENNEEUROPISCHE NORMEN ISO 10651-4April 2009ICS 11.040.10 Supersedes EN ISO 10651-4:2002 Engl
5、ish VersionLung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)Ventilateurs pulmonaires - Partie 4: Exigences relatives auxressuscitateurs puissance motrice manuelle (ISO 10651-4:2002)Lungenbeatmungsgerte - Teil 4: Anforderungen ananwenderbetrieben
6、e Wiederbelebungsgerte(Handbeatmungsgerte) (ISO 10651-4:2002)This European Standard was approved by CEN on 21 March 2009.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without
7、 any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the CEN Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made
8、 by translationunder the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as theofficial versions.CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,France, G
9、ermany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNGM
10、anagement Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10651-4:2009: EBS EN ISO 10651-4:2009EN ISO 10651-4:2009 (E) 3 Foreword The text of ISO 10651-4:2002 has been prepared by Te
11、chnical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10651-4:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This Euro
12、pean Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by October 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the eleme
13、nts of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 10651-4:2002. This document has been prepared under a mandate given to CEN by the European Commission and the Euro
14、pean Free Trade Association, and supports essential requirements of EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countri
15、es are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
16、 Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 10651-4:2002 has been approved by CEN as a EN ISO 10651-4:2009 without any modification. BS EN ISO 10651-4:2009EN ISO 10651-4:2009 (E) 4 Annex ZA (Informative) Relationship between this European Standard and the Essentia
17、l Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Onc
18、e this standard is cited in the Official Journal of the European Communities under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
19、 presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and EU Directives Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying rem
20、arks/Notes All 1 (1st paragraph), 2 4.1 3, 9.1 4.2 9.14.3 3, 9.1 4.4 9.1 4.5 3, 9.14.6 3, 7.1, 7.6, 9.1 4.7 3, 7.3, 9.1 4, 5, 9, 10 1 (2nd paragraph, 1st dash) This relevant Essential Requirement is not fully addressed in this European Standard 4, 5, 9, 10 1 (2nd paragraph, 2nd dash) This relevant E
21、ssential Requirement is not fully addressed in this European Standard - 6a)This relevant Essential Requirement is not addressed in this European Standard 5.1 4, 9.2 5.2 3, 4, 9.2 5.3 3, 4, 7.6 5.4 3, 4, 5 5.5 4, 55.7 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in t
22、his European Standard BS EN ISO 10651-4:2009EN ISO 10651-4:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes5.7 7.5 (2nd paragraph) This relevant Essential Requirement is not fully addressed in this European Standard - 7.5 (3rd
23、 paragraph) This relevant Essential Requirement is not addressed in this European Standard 6.1 3, 9.1 6.2 9.26.3 3, 9.26.4 9.1, 6.5 3, 7.5, 9.2 6.6 3, 9.26.7.1 3 6.7.2 3, 9.2, 12.8.2 7.1 3, 5, 9.2 7.2 3, 9.28.1 8.1, 8.3, 8.4, 8.5 8.2 8.1, 8.3, 8.4, 8.5 9 13.3 (a): This relevant Essential Requirement
24、 is not fully addressed in this European Standard 9.1 2, 6, 13.1, 13.2 9.2 5, 9.2, 13.1, 13.2 9.3 13.3, 13.49, 10 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 9, 10 13.6 (h)(2nd paragraph) This relevant Essential Requirement is not fully addressed in
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