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EN ISO 10651-2:2004

(Main)

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)

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)

Joint revision of EN 794-2:1997 and ISO 10654-2:1996 (TC Res 373/2001) (CC/010511)

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)

Es gilt IEC 60601-1:1988, Abschnitt 1 mit folgenden Ausnahmen:
Änderung:
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 unterschiedlichen Ausbildungsgrades 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)

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Withdrawn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
30-Jun-2004
Withdrawal Date
07-Apr-2009
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
Start Date
08-Apr-2009
Completion Date
08-Apr-2009
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 10651-2:2005 - 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 794-2:1997 - Lung ventilators - Part 2: Particular requirements for home care use
Effective Date
22-Dec-2008
Replaced By
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)
Effective Date
22-Dec-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10651-2:2005
01-januar-2005
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SIST EN 794-2:2000
3OMXþQLYHQWLODWRUML]DXSRUDERYPHGLFLQL±3RVHEQH]DKWHYH]DRVQRYQRYDUQRVW
LQELVWYHQHODVWQRVWL±GHO9HQWLODWRUML]DRVNUERRGDSDUDWDRGYLVQLKSDFLHQWRY
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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 a usage médical - Exigences particulieres pour la sécurité de
base et les performances essentielles - Partie 2: Ventilateurs pour soins a domicile pour
patients dépendants (ISO 10651-2:2004)
Ta slovenski standard je istoveten z: EN ISO 10651-2:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-2:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10651-2:2005

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SIST EN ISO 10651-2:2005

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SIST EN ISO 10651-2:2005

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SIST EN ISO 10651-2:2005

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SIST EN ISO 10651-2:2005

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SIST EN ISO 10651-2:2005


INTERNATIONAL ISO
STANDARD 10651-2
Second edition
2004-07-01


Lung ventilators for medical use —
Particular requirements for basic safety
and essential performance —
Part 2:
Home care ventilators for ventilator-
dependent patients
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




Reference number
ISO 10651-2:2004(E)
©
ISO 2004

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SIST EN ISO 10651-2:2005
ISO 10651-2:2004(E)
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©  ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
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Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland

ii © ISO 2004 – All rights reserved

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SIST EN ISO 10651-2:2005
ISO 10651-2:2004(E)
Contents Page
Foreword. vi
Introduction . vii
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 General requirements and requirements for tests . 3
5 Classification.
...

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NOTE 2    This document has been prepared to address the relevant essential principles[24] and labelling[25] guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex D.
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