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CEN

EN ISO 10651-6:2009

(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)

ISO 10651-6:2004 specifies the basic safety and essential performance requirements for home-care ventilatory support devices, intended mainly for use in home care but which could be used elsewhere (e.g. in hospitals) for appropriate patients for whom the use of a home-care ventilator complying with ISO 10651-2 is not required. It is intended to be used in conjunction with the General Standard IEC 60601-1:1988.
The requirements of ISO 10651-6:2004 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 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 Gesundheitseinrichtungen)
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)

L'ISO 10651-6:2004 spécifie les exigences fondamentales en matière de sécurité et de performance essentielle pour les dispositifs d'assistance respiratoire à domicile, destinés principalement à être utilisés dans le cadre des soins à domicile mais qui pourraient être utilisés ailleurs (par exemple dans des hôpitaux) pour des patients appropriés lorsque l'utilisation d'un ventilateur de soins à domicile conforme à l'ISO 10651-2 n'est pas nécessaire.Elle est destinée à être utilisée conjointement avec la norme générale CEI 60601-1:1988.
Les exigences de l'ISO 10651-6:2004 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 - 6. del: Ventilatorji in naprave za podporo pri dihanju pacientov v oskrbi na domu (ISO 10651-6:2004)

General Information

Status
Withdrawn
Publication Date
07-Apr-2009
Withdrawal Date
17-Sep-2019
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
18-Sep-2019
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
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 10651-6:2009 - Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)

Relations

Replaces
EN 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)
Effective Date
15-Apr-2009
Replaced By
EN ISO 80601-2-80:2019 - Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (ISO 80601-2-80:2018)
Effective Date
30-Oct-2019
Replaced By
EN ISO 80601-2-79:2019 - Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment (ISO 80601-2-79:2018)
Effective Date
30-Oct-2019

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 10651-6:2009
01-julij-2009
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SIST EN ISO 10651-6:2005
3OMXþQLYHQWLODWRUML]DXSRUDERYPHGLFLQL3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLGHO9HQWLODWRUMLLQQDSUDYH]DSRGSRURSULGLKDQMXSDFLHQWRY
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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 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)
Ta slovenski standard je istoveten z: EN ISO 10651-6:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 10651-6:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN ISO 10651-6:2009

---------------------- Page: 2 ----------------------

SIST EN ISO 10651-6:2009
EUROPEAN STANDARD
EN ISO 10651-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 10651-6:2004
English Version
Lung ventilators for medical use - Particular requirements for
basic safety and essential performance - Part 6: Home-care
ventilatory support devices (ISO 10651-6:2004)
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 6: Dispositifs d'assistance respiratoire einschließlich der wesentlichen Leistungsmerkmale - Teil 6:
à domicile (ISO 10651-6:2004) Heimbeatmungsgeräte zur Atemunterstützung (ISO 10651-
6:2004)
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 10651-6:2009: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (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

---------------------- Page: 4 ----------------------

SIST EN ISO 10651-6:2009
EN ISO 10651-6:2009 (E)
Foreword
The text of ISO 10651-6:2004 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 10651-6:2009 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 10651-6:2004.
This docu
...

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