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EN 1820:2005

(Main)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

This document specifies requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung-ventilator breathing systems. It includes requirements for the design of the neck, size designation, distension and, where relevant, for electrical resistance.
This document is not applicable to special-purpose bags, for example bellows and self-expanding bags. Bags for use with anaesthetic gas scavenging systems are not considered to be anaesthetic reservoir bags and are thus outside the scope of this document.

Anästhesie-Reservoirbeutel (ISO 5362:2000, geändert)

Diese Europäische Norm legt Anforderungen an antistatische und nicht antistatische Reservoirbeutel für den
Gebrauch mit Anästhesie- oder Beatmungsgeräten fest. Es enthält Festlegungen zur Ausführung der Muffe,
den Größen, der Dehnung und gegebenenfalls zum elektrischen Widerstand.
Beutel für besondere Zwecke, z. B. Bälge und selbstentfaltende Beutel, gehören nicht zum Anwendungs-
bereich dieses Dokuments. Beutel für den Gebrauch mit Anästhesiegas-Fortleitungssystemen werden nicht
als Anästhesie-Reservoirbeutel angesehen und gehören nicht zum Anwendungsbereich dieses Dokuments.

Ballons réservoirs d'anesthésie (ISO 5362:2000, modifiée)

La présente Norme européenne fixe les prescriptions relatives aux ballons réservoirs antiélectrostatiques et
non antiélectrostatiques destinés à être utilisés avec les appareils d'anesthésie ou les systèmes respiratoires
de ventilateurs pulmonaires. Elle fixe des prescriptions relatives à la conception du col, la désignation de la
taille, la distension et, le cas échéant, les prescriptions relatives à la résistance électrique.
Les ballons destinés à une utilisation spéciale, par exemple les soufflets ou les ballons à autodilatation, ne
sont pas traités dans le présent document. Les ballons destinés à être utilisés avec les systèmes d'évacuation
de gaz d'anesthésie en excès ne sont pas considérés comme des ballons réservoirs d'anesthésie, et ne
relèvent donc pas du domaine d'application du présent document.

Dihalni baloni (ISO 5362:2000, spremenjen)

General Information

Status
Withdrawn
Publication Date
31-May-2005
Withdrawal Date
11-Aug-2009
ICS
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 4 - Tracheal tubes and other equipment
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
12-Aug-2009
Completion Date
12-Aug-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 1820:2005 - Anaesthetic reservoir bags (ISO 5362:2000, modified)

Relations

Replaces
EN 1820:1997 - Anaesthetic reservoir bags
Effective Date
22-Dec-2008
Merged Into
EN 1820:2005+A1:2009 - Anaesthetic reservoir bags (ISO 5362:2000, modified)
Effective Date
20-Jun-2009
Amended By
EN 1820:2005/prA1 - Anaesthetic reservoir bags (ISO 5362:2000, modified)
Effective Date
22-Dec-2008

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 1820:2005
01-september-2005
1DGRPHãþD
SIST EN 1820:2000
Dihalni baloni (ISO 5362:2000, spremenjen)
Anaesthetic reservoir bags (ISO 5362:2000, modified)
Anästhesie-Reservoirbeutel (ISO 5362:2000, geändert)
Ballons réservoirs d'anesthésie (ISO 5362:2000, modifiée)
Ta slovenski standard je istoveten z: EN 1820:2005
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN 1820:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 1820:2005

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SIST EN 1820:2005



EUROPEAN STANDARD EN 1820

NORME EUROPÉENNE

EUROPÄISCHE NORM
June 2005
ICS 11.040.10 Supersedes EN 1820:1997
English version
Anaesthetic reservoir bags (ISO 5362:2000, modified)
Ballons réservoirs d'anesthésie (ISO 5362:2000, modifiée) Anästhesie-Reservoirbeutel (ISO 5362:2000, geändert)
This European Standard was approved by CEN on 25 April 2005.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.






EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2005 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1820:2005: E
worldwide for CEN national Members.

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SIST EN 1820:2005
EN 1820:2005 (E)
Contents Page
Foreword.4
Introduction .5
1 Scope .6
2 Normative references .6
3 Terms and definitions .6
4 General requirements.7
5 Prevention of electrostatic charges.9
6 Requirements for bags supplied sterile .9
7 Marking .9
8 Information to be supplied by the manufacturer.10
Annex A (informative) Test for leakage.11
A.1  Principle .11
A.2  Apparatus.11
A.3  Procedure.11
A.4  Expression of results.11
Annex B (normative) Determination of capacity .12
B.1
...

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