EN ISO 10651-4:2009

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

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 04-Apr-2023
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 2 - Lung ventilators
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 10651-4:2009 - Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)

Relations

• Replaces: EN ISO 10651-4:2002/AC:2006 - Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
• Effective Date: 15-Apr-2009
• Replaces: EN ISO 10651-4:2002 - Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 10651-4:2023 - Lung ventilators - Part 4: Particular requirements for user-powered resuscitators (ISO 10651-4:2023)
• Effective Date: 30-Jan-2019

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



SIST EN ISO 10651-4:2009



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



EN ISO 10651-4:2009 (E) 2 Contents Page Foreword .3Annex ZA (Informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC .4 SIST EN ISO 10651-4:2009



EN ISO 10651-4:2009 (E) 3 Foreword The text of ISO 10651-4:2002 has been prepared by Technical 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 European 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 elements 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 European 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 countries 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, 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. SIST EN ISO 10651-4:2009



EN ISO 10651-4:2009 (E) 4 Annex ZA (Informative)
Relationship between this European Standard and th
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