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CEN

EN ISO 10651-6:2004

(Main)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 6: Heimbeatmungsgeräte zur Atemunterstützung (ISO 10651-6:2004)

Es gilt IEC 60601-1:1988, Abschnitt 1 mit folgenden Ausnahmen:
Änderung:
Dieser Teil von ISO 10651 legt Anforderungen an die grundlegende Sicherheit und die wesentlichen Leistungsmerkmale für Heimbeatmungsgeräte zur Atemunterstützung fest, die zur Verwendung bei der häuslichen Pflege von Patienten bestimmt sind, die aber auch an anderer Stelle (z. B. in Krankenhäusern) für Patienten verwendet werden können, bei denen ein Heimbeatmungsgeräte nach ISO 10651-2 nicht erforderlich ist.
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 6: Dispositifs d'assistance respiratoire à domicile (ISO 10651-6:2004)

Pljučni ventilatorji za uporabo v medicini – Posebne zahteve za osnovno varnost in bistvene lastnosti – 6. del: Ventilatorji in naprave za podporo pri dihanju pacientov v oskrbi na domu (ISO 10651-6:2004)

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Withdrawn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/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 10651-6:2005 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

Relations

Replaced By
EN ISO 10651-6:2009 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
Effective Date
15-Apr-2009

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SLOVENSKI STANDARD
SIST EN ISO 10651-6:2005
01-januar-2005
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LQELVWYHQHODVWQRVWL±GHO9HQWLODWRUMLLQQDSUDYH]DSRGSRURSULGLKDQMX
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Lung ventilators for medical use - Particular requirements for basic safety and essential
performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
Beatmungsgeräte für die medizinische Anwendung - Besondere Festlegungen für die
grundlegende Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Teil 6:
Heimbeatmungsgeräte zur Atemunterstützung (ISO 10651-6:2004)
Ventilateurs pulmonaires a usage médical - Exigences particulieres pour la sécurité de
base et les performances essentielles - Partie 6: Dispositifs d'assistance respiratoire a
domicile (ISO 10651-6:2004)
Ta slovenski standard je istoveten z: EN ISO 10651-6:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-6:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005

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SIST EN ISO 10651-6:2005


INTERNATIONAL ISO
STANDARD 10651-6
First edition
2004-07-01


Lung ventilators for medical use —
Particular requirements for basic safety
and essential performance —
Part 6:
Home-care ventilatory support devices
Ventilateurs pulmonaires à usage médical — Exigences particulières
pour la sécurité de base et les performances essentielles —
Partie 6: Dispositifs d'assistance respiratoire à domicile




Reference number
ISO 10651-6:2004(E)
©
ISO 2004

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SIST EN ISO 10651-6:2005
ISO 10651-6:2004(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 10651-6:2005
ISO 10651-6:2004(E)
Contents Page
Foreword . vi
Introduction . vii
1 Scope . 1
2 Normative references. 1
3 Terms and definitions . 2
4 General requirements and general requirements for tests. 3
5 Classification . 3
6 Identification, marking and documents.
...

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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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