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3、:2002 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of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
25、this European Standard 10 9.3, 13.1, 13.2, 13.3, 13.4, 13.6 10 13.6 (q) This relevant Essential Requirement is not addressed in this European Standard All other requirements are not applicable to this standard WARNING: Other requirements and other EU Directives may be applicable to the product(s) fa
26、lling within the scope of this standard. BS EN ISO 10651-4:2009ISO 10651-4:2002(E) ISO 2002 All rights reserved iiiForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standar
27、ds is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take
28、 part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. The main task of technical committees is
29、to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility
30、 that some of the elements of this part of ISO 10651 may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 10651-4 was prepared by the European Committee for Standardization (CEN) in collaboration with Technical Committee ISO/TC 121
31、, Anaesthetic and respiratory equipment, Subcommittee SC 3, Lung ventilators and related equipment, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement). Throughout the text of this document, read “.this European Standard.“ to mean “.this International Sta
32、ndard.“. ISO 10651 consists of the following parts, under the general title Lung ventilators: Part 1: Requirements Part 2: Particular requirements for home care ventilators Part 3: Particular requirements for emergency and transport ventilators Part 4: Particular requirements for operator-powered re
33、suscitators Annex A forms a normative part of this part of ISO 10651. Annex B is for information only. For the purposes of this part of ISO 10651, the CEN annex regarding fulfilment of European Council Directives has been removed. BS EN ISO 10651-4:2009ISO 10651-4:2002(E) iv ISO 2002 All rights rese
34、rvedContentsPageForewordv1Scope12Normative references13Terms and definitions14Connectors.35Operational requirements.36Ventilatory requirements.47Storage and operating conditions68Requirements for resuscitator, or parts, supplied sterile.69Marking.610Information to be provided by the manufacturer in
35、operating and maintenance instructions.7Annex A (normative) Test methods.9Annex B (informative) Rationale19Bibliography22BS EN ISO 10651-4:2009ISO 10651-4:2002(E) ISO 2002 All rights reserved vForewordThis document (EN ISO 10651-4:2002) has been prepared by Technical Committee CEN/TC 215 “Respirator
36、y andanaesthetic equipment“, the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC121 “Anaesthetic and respiratory equipment“.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at t
37、he latest by September 2002, and conflicting national standards shall be withdrawn at thelatest by September 2002.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports essential requirements of EU Directive(s).Ann
38、ex A is normative and form part of this European Standard.Annex B is for information only.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard : Austria, Belgium, Czech Republic, Denmark, Finla
39、nd,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.BS EN ISO 10651-4:2009BS EN ISO 10651-4:2009ISO 10651-4:2002(E) ISO 2002 All rights reserved 11 ScopeThis European Standard specifies requirements f
40、or operator-powered resuscitators intended for use with all agegroups and which are portable and intended to provide lung ventilation to individuals whose breathing isinadequate. Operator-powered resuscitators for infants and children are designated according to body mass rangeand approximate age eq
41、uivalent.Electrically- and gas-powered resuscitators are not covered by this European Standard.NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses whichhave corresponding rationale statements are marked with R) after their number.2 Normative
42、 referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in text and the publications are listed hereafter. For datedreferences, subsequent amendments to or revisions of any of thes
43、e publications apply to this European Standardonly when incorporated in it by amendment or revision. For undated references the latest edition of the publicationreferred to applies (including amendments).EN 148-1, Respiratory protective devices - Threads for facepieces Part 1: Standard thread connec
44、tion.EN 556: 1994+A1:1998, Sterilization of medical devices - Requirements for terminally-sterilized medical devices tobe labelled “STERILE”.EN 737-1, Medical gas pipeline systems - Part 1: Terminal units for compressed medical gases and vacuum.EN 868-1, Packaging materials and systems for medical d
45、evices which are to be sterilized - Part 1: Generalrequirements and test methods .EN 1041, Information supplied by the manufacturer with medical devices.EN 1281-1, Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.prEN 13544-2:2000, Respiratory therapy equipment
46、Part 2 : Specifications for tubing and connectors.EN ISO 4135:1996, Anaesthesiology Vocabulary (ISO 4135 :1995).3 Terms and definitionsFor the purposes of this part of EN ISO 10651, the terms and definitions given in EN ISO 4135:1996 and thefollowing terms and definitions apply.NOTE Some of the defi
47、nitions have been taken from EN ISO 4135, but they are included in this European Standard forconvenience; other definitions, which are given in EN ISO 4135, for apparatus in general, have been modified slightly for thepurposes of this European Standard as they apply specifically to resuscitators.3.1
48、reverse leakagevolume of expired gas which does not pass through the expiratory port but returns to the resuscitator3.2bag inlet valvevalve activated by the subatmospheric pressure in the compressible unit of the resuscitator to refill thecompressible unit with gas at ambient pressure3.3bag refill v
49、alvevalve, with no manual trigger, activated by the sub-atmospheric pressure in the compressible unit of theresuscitator to refill the compressible unit from a pressurized gas sourceBS EN ISO 10651-4:2009ISO 10651-4:2002(E) 2 ISO 2002 All rights reserved3.4compressible unitthat part of an operator-powered resuscitator e.g. a bag or bellows that, when compressed by the operator, deliversa volume of gas3.5delivered oxygen concentrationaverage concentration of oxygen in the gas delivered from the resuscitator3.6delivered volume, Vdelvolume of g
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