BS EN ISO 10651-6-2009 Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Home-care ventilatory support devices《医用肺通气器 基本安全性和必要.pdf
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1、BS EN ISO10651-6:2009ICS 11.040.10NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDLung ventilators formedical useParticular requirements for basicsafety and essential performance Part 6: Home-care ventilatory supportdevices (ISO 10651-6:2004)This British Standar
2、dwas published under theauthority of the StandardsPolicy and StrategyCommittee on 30 June2009. BSI 2009ISBN 978 0 580 65479 4Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 10651-6:2009National forewordThis British Standard is the UK implementation of EN ISO10651-6:2009. It is i
3、dentical to ISO 10651-6:2004. It supersedes BS ENISO 10651-6:2004 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of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 onreq
4、uest to its secretary.This publication does not purport to include 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-
5、6April 2009ICS 11.040.10 Supersedes EN ISO 10651-6:2004 English VersionLung ventilators for medical use - Particular requirements forbasic safety and essential performance - Part 6: Home-careventilatory support devices (ISO 10651-6:2004)Ventilateurs pulmonaires usage mdical - Exigencesparticulires p
6、our la scurit de base et les performancesessentielles - Partie 6: Dispositifs dassistance respiratoire domicile (ISO 10651-6:2004)Beatmungsgerte fr die medizinische Anwendung -Besondere Festlegungen fr die grundlegende Sicherheiteinschlielich der wesentlichen Leistungsmerkmale - Teil 6:Heimbeatmungs
7、gerte zur Atemuntersttzung (ISO 10651-6:2004)This European Standard was approved by CEN on 14 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 any alteration.
8、 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 by translationu
9、nder 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, Germany, Greece,
10、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 NORMUNGManagement Centre
11、: 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 10651-6:2009: EBS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 3 Foreword The text of ISO 10651-6:2004 has been prepared by Technical Committe
12、e ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 10651-6:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. This European Standard sh
13、all 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 elements of this docu
14、ment 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 10651-6:2004. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade
15、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 countries are bound to
16、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, Sweden, Switzer
17、land and the United Kingdom. Endorsement notice The text of ISO 10651-6:2004 has been approved by CEN as a EN ISO 10651-6:2009 without any modification. BS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements o
18、f 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. Once this standard
19、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 presumption of
20、conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes
21、All 1, 2, 3 4 (3.1) 4, 12.1 4 (3.4) 2 5.2 12.66.1 2, 13.16.1 7.5 (2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 e) 13.3 a) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 q) 13.3 k) 6.1 aa), 6.1 bb) 13.
22、2 6.1 cc) 13.3i) 6.1 dd) 13.3 i), 13.6 k) 6.1 ee) 13.3 e) 6.1 ff) 13.3 b), 13.3 f) 6.1 ff) 13.3 (f) This relevant Essential Requirement is not fully addressed in this European Standard 6.1 ff) 2) 13.2 6.1 ff) 3) 13.3 d), 13.5 6.1 ff) 4) 13.3 a) 6.1 ff) 5) 13.3 k) 6.1 ff) 6) 13.3 c) 6.1 ff) 8) 13.3 m
23、) 6.1 gg) 12.8.2, 13.2, 13.3 i) BS EN ISO 10651-6:2009EN ISO 10651-6:2009 (E) 5 Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes6.1 hh) 8.7 6.3 2, 10, 12.96.6 12.7.46.8 7.5 (3rdparagraph) This relevant Essential Requirement is not fully
24、addressed in this European Standard 6.8.2 2, 9.1, 13 6.8.2 d) 13.6 a), 13.6 h), 13.6 i) 6.8.2 d) 13.6 (h)(2ndparagraph) This relevant Essential Requirement is not fully addressed in this European Standard 6.8.2 aa) 1) 13.4 6.8.2 aa) 2) 13.6 c) 6.8.2 aa) 4), 6.8.2 aa) 5), 6.8.2 aa) 6) 12.2, 13.6 d) 6
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