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SIST EN 794-2:2000

(Main)

Lung ventilators - Part 2: Particular requirements for home care use

Lung ventilators - Part 2: Particular requirements for home care use

Clause 1 of EN 60601-1: 1990 applies except that 1.1 is replaced by the following:  1.1 This Part of this European Standard specifies requirements for lung ventilators intended mainly for home care use1) for patients but which could be used elsewhere (hospitals) for appropriate patients in locations where the use of a ventilator complying with Part 1 of this Standard is not required. Additional parts, e.g. concerning emergency and transport ventilators, and recent developments such as jet and very high frequency ventilation and oscillation are under consideration.

Lungenbeatmungsgeräte - Teil 2: Besondere Anforderungen für Heimbeatmungsgeräte

Der Anwendungsbereich nach Abschnitt 1 von EN 60601-1:1990 gilt mit folgender Ergänzung: 1.5 Dieser Teil der Europäischen Norm gibt Anforderungen für Lungenbeatmungsgeräte an, die hauptsächlich zur Verwendung bei der häuslichenPflege von Patienten bestimmt sind*, jedoch an anderer Stelle (in Krankenhäusern) an den jeweiligen Patienten dort verwendet werden könnten, wo die Verwendung eines Beatmungsgerätes entsprechend Teil 1 dieser Norm nicht erforderlich ist.

Ventilateurs pulmonaires - Partie 2: Prescriptions particulieres pour l'emploi a domicile

Le domaine d'application indiqué dans l'article 1 de l'EN 60601-1990 s'applique,avec l'additif suivant: 1.5 La présente partie de la norme européenne spécifie les prescriptions relatives aux ventilateurs pulmonaires destinés principalementa etre utilisés par des patients a domicile*, mais qui pourraient etre utilisés ailleurs (en hôpital) pour certains patients, dans des lieux ou il n'est pas nécessaire d'utiliser un ventilateur pulmonaire conforme a la partie 1de la présente norme.

Pljučni ventilatorji - 2. del: Posebne zahteve za uporabo na domu

General Information

Status
Withdrawn
Publication Date
31-Dec-1999
Withdrawal Date
30-Jun-2005
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
VAZ - Healthcare
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
01-Jul-2005
Due Date
01-Jul-2005
Completion Date
01-Jul-2005
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
EN 794-2:1997 - Lung ventilators - Part 2: Particular requirements for home care use

Relations

Replaced By
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)
Effective Date
01-Jul-2005

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SLOVENSKI STANDARD
SIST EN 794-2:2000
01-januar-2000
3OMXþQLYHQWLODWRUMLGHO3RVHEQH]DKWHYH]DXSRUDERQDGRPX
Lung ventilators - Part 2: Particular requirements for home care use
Lungenbeatmungsgeräte - Teil 2: Besondere Anforderungen für Heimbeatmungsgeräte
Ventilateurs pulmonaires - Partie 2: Prescriptions particulieres pour l'emploi a domicile
Ta slovenski standard je istoveten z: EN 794-2:1997
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 794-2:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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