EN ISO 10651-4:2009
(Main)Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
ISO 10651-4:2002 specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent.
ISO 10651-4:2002 is not applicable to electrically- and gas-powered resuscitators.
Rationale statements are given for ISO 10651-4:2002.
Lungenbeatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2002)
Diese Europäische Norm legt Anforderungen an anwenderbetriebene, tragbare Wiederbelebungsgeräte
(Handbeatmungsgeräte) fest, die zur Anwendung an Menschen aller Altersstufen und zur Lungenbeatmung
bei Personen mit unzureichender Atemtätigkeit vorgesehen sind. Anwenderbetriebene Wiederbelebungsgeräte
für Kleinkinder und Kinder sind entsprechend dem Bereich des Körpergewichts und dem ungefähren
Alter festlegt.
Elektrisch- oder gasbetriebene Wiederbelebungsgeräte sind in dieser Norm nicht enthalten.
ANMERKUNG Anhang B enthält Begründungen zu diesem Teil dieser Europäischen Norm. Die Abschnitte und
Unterabschnitte mit einer entsprechenden Begründung sind mit dem Buchstaben R) hinter der Abschnittsnummer
gekennzeichnet.
Ventilateurs pulmonaires - Partie 4: Exigences relatives aux ressuscitateurs à puissance motrice manuelle (ISO 10651-4:2002)
L'ISO 10651-4 spécifie les exigences relatives aux ressuscitateurs portatifs à puissance motrice manuelle destinés à être utilisés pour tous les groupes d'âges et conçus pour assurer la ventilation des poumons de sujets dont la respiration est insuffisante. Les ressuscitateurs à puissance motrice manuelle pour enfants en bas âge et enfants doivent être conçus en fonction du poids du sujet et de l'âge approximatif correspondant.
L'ISO 10651-4 n'est pas applicable aux ressuscitateurs dont la puissance motrice est électrique ou à gaz.
Les justifications des exigences énoncées pour l'ISO 10651-4 sont présentées dans une annexe.
Pljučni ventilatorji - 4. del: Posebne zahteve za naprave za oživljanje, ki jih upravlja operater (ISO 10651-4:2002)
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Lungenbeatmungsgeräte - Teil 4: Anforderungen an anwenderbetriebene Wiederbelebungsgeräte (Handbeatmungsgeräte) (ISO 10651-4:2002)Ventilateurs pulmonaires - Partie 4: Exigences relatives aux ressuscitateurs à puissance motrice manuelle (ISO 10651-4:2002)Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN ISO 10651-4:2009SIST EN ISO 10651-4:2009en01-julij-2009SIST EN ISO 10651-4:2009SLOVENSKI
STANDARDSIST EN ISO 10651-4:2002/AC:2006SIST EN ISO 10651-4:20021DGRPHãþD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN ISO 10651-4April 2009ICS 11.040.10Supersedes EN ISO 10651-4:2002
English VersionLung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)Ventilateurs pulmonaires - Partie 4: Exigences relatives auxressuscitateurs à puissance motrice manuelle (ISO 10651-4:2002)Lungenbeatmungsgeräte - Teil 4: Anforderungen ananwenderbetriebene Wiederbelebungsgeräte(Handbeatmungsgeräte) (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 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 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, Germany, 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2009 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN ISO 10651-4:2009: ESIST EN ISO 10651-4:2009
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 10651-4:2009
Relationship between this European Standard and the Essential 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. Once 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 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 remarks/Notes All 1 (1st paragraph), 2
4.1 3, 9.1
4.2 3, 9.1
4.3 3, 9.1
4.4 9.1
4.5 3, 9.1
4.6 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 Essential 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, 5
5.7 7.5 (1st paragraph) This relevant Essential Requirement is not fully addressed in this European Standard SIST EN ISO 10651-4:2009
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 paragraph) This relevant Essential Requirement is not addressed in this European Standard 6.1 3, 9.1
6.2 3, 9.2
6.3 3, 9.2
6.4 3, 9.1,
6.5 3, 7.5, 9.2
6.6 3, 9.2
6.7.1 3
6.7.2 3, 9.2, 12.8.2
7.1 3, 5, 9.2
7.2 3, 9.2
8.1 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 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, 13.4
9, 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 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) falling within the scope of this standard. SIST EN ISO 10651-4:2009
Reference numberISO 10651-4:2002(E)© ISO 2002
INTERNATIONAL STANDARD ISO10651-4First edition2002-03-01Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators Ventilateurs pulmonaires — Partie 4 : Exigences relatives aux ressuscitateurs à puissance motrice manuelle
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ii © ISO 2002 – All rights reserved
ISO 10651-4:2002(E) © ISO 2002 – All rights reserved iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards 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 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 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 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, 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 Standard.". 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 resuscitators 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. SIST EN ISO 10651-4:2009
ISO 10651-4:2002(E) iv © ISO 2002 – All rights reserved
ContentsPageForeword.v1Scope.12Normative references.13Terms and definitions.14Connectors.35Operational requirements.36Ventilatory requirements.47Storage and operating conditions.68Requirements for resuscitator, or parts, supplied sterile.69Marking.610Information to be provided by the manufacturer in operating and maintenance instructions.7Annex A (normative)
Test methods.9Annex B (informative)
Rationale.19Bibliography.22SIST EN ISO 10651-4:2009
ISO 10651-4:2002(E) © ISO 2002 – All rights reserved v
ForewordThis document (EN ISO 10651-4:2002) has been prepared by Technical Committee CEN/TC 215 "Respiratory 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 the 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).Annex A is normative and form part of this Europe
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