EN ISO 10651-2:2009

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

ISO 10651-2:2004 specifies requirements for lung ventilators intended for home applications for those patients who are dependent on ventilatory support. Such ventilators are considered life-supporting equipment, are frequently used in locations where driving power is not reliable, and are often supervised by non-healthcare personnel with different levels of training.
ISO 10651-2:2004 is intended to be used in conjunction with the General Standard IEC 60601-1:1988.
ISO 10651-2:2004 is not applicable to cuirass and 'iron-lung' ventilators.
ISO 10651-2:2004 is not applicable to ventilators intended only to augment the ventilation of spontaneously breathing patients.
The requirements of ISO 10651-2:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.

Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 2: Heimbeatmungsgeräte für vom Gerät abhängige Patienten (ISO 10651-2:2004)

Dieser Teil von ISO 10651 legt Anforderungen für Beatmungsgeräte fest, die zur Verwendung bei der häuslichen Pflege von Patienten bestimmt sind, die von der Atemunterstützung abhängig sind. Diese Beatmungsgeräte werden als lebenserhaltende Geräte angesehen. Diese Beatmungsgeräte werden oft an Orten verwendet, an denen die Antriebsenergie nicht zuverlässig ist. Sie werden oft durch nichtmedizinisches Personal mit unterschiedlichen Ausbildungsgraden überwacht.
Dieser Teil von ISO 10651 gilt nicht für den Körper umschließende sowie in Form einer „Eisernen Lunge“ vorliegende Beatmungsgeräte.
Dieser Teil von ISO 10651 gilt nicht für Beatmungsgeräte, die nur dazu bestimmt sind, den Atmungsumfang spontan atmender Patienten zu vergrößern.
Es ist davon auszugehen, dass die Anforderungen von diesem Teil von ISO 10651, die die Anforderungen von IEC 60601 1:1988 und ihrer Änderungen 1 (1991) und 2 (1995) ersetzen oder verändern, Vorrang vor den entsprechenden allgemeinen Anforderungen haben.

Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de base et les performances essentielles - Partie 2: Ventilateurs pour soins à domicile pour patients dépendants (ISO 10651-2:2004)

L'ISO 10651-2:2004 spécifie les exigences relatives aux ventilateurs pulmonaires destinés aux applications à domicile par des patients qui dépendent d'une assistance respiratoire. Ces ventilateurs sont considérés comme un équipement vital, sont souvent utilisés dans des endroits où la fiabilité de la puissance motrice n'est pas assurée, et sont fréquemment supervisés par un personnel non médical ayant différents niveaux de formation.
L'ISO 10651-2:2004 n'est pas destinée à être utilisée avec la norme générale CEI 60601-1:1988.
L'ISO 10651-2:2004 n'est pas applicable aux ventilateurs de type cuirasse ou «poumon d'acier».
Les ventilateurs qui sont exclusivement destinés à augmenter la ventilation des patients qui respirent de manière spontanée sont exclus du domaine d'application de l'ISO 10651-2:2004.
Les exigences de l'ISO 10651-2:2004 qui remplacent ou modifient les exigences de la CEI 60601-1:1988 et ses Amendements 1 (1991) et 2 (1995) sont destinés à avoir la priorité sur les exigences générales correspondantes.

Pljučni ventilatorji za uporabo v medicini - Posebne zahteve za osnovno varnost in bistvene lastnosti - 2. del: Ventilatorji za oskrbo od aparata odvisnih pacientov na domu (ISO 10651-2:2004)

General Information

• Status: Withdrawn
• Publication Date: 07-Apr-2009
• Withdrawal Date: 22-Sep-2015
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 23-Sep-2015
• 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 10651-2:2009 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)

Relations

• Replaces: EN ISO 10651-2:2004 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 80601-2-72:2015 - Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10651-2:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 10651-2:2005
3OMXþQLYHQWLODWRUML]DXSRUDERYPHGLFLQL3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLGHO9HQWLODWRUML]DRVNUERRGDSDUDWDRGYLVQLKSDFLHQWRYQD
GRPX,62
Lung ventilators for medical use - Particular requirements for basic safety and essential
performance - Part 2: Home care ventilators for ventilator-dependent patients (ISO
10651-2:2004)
Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die
grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 2:
Heimbeatmungsgeräte für vom Gerät abhängige Patienten (ISO 10651-2:2004)
Ventilateurs pulmonaires à usage médical - Exigences particulières pour la sécurité de
base et les performances essentielles - Partie 2: Ventilateurs pour soins à domicile pour
patients dépendants (ISO 10651-2:2004)
Ta slovenski standard je istoveten z: EN ISO 10651-2:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10651-2:2009

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SIST EN ISO 10651-2:2009
EUROPEAN STANDARD
EN ISO 10651-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 10651-2:2004
English Version
Lung ventilators for medical use - Particular requirements for
basic safety and essential performance - Part 2: Home care
ventilators for ventilator-dependent patients (ISO 10651-2:2004)
Ventilateurs pulmonaires à usage médical - Exigences Beatmungsgeräte für die medizinische Anwendung -
particulières pour la sécurité de base et les performances Besondere Festlegungen für die grundlegende Sicherheit
essentielles - Partie 2: Ventilateurs pour soins à domicile einschließlich der wesentlichen Leistungsmerkmale - Teil 2:
pour patients dépendants (ISO 10651-2:2004) Heimbeatmungsgeräte für vom Gerät abhängige Patienten
(ISO 10651-2:2004)
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 European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards 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 translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official 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 STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10651-2:2009: E
worldwide for CEN national Members.

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

2

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SIST EN ISO 10651-2:2009
EN ISO 10651-2:2009 (E)
Foreword
The text of ISO 10651-2:2004 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 10651-2:2009 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 pat
...