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CEN

EN 1820:2005+A1:2009

(Main)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

Anaesthetic reservoir bags (ISO 5362:2000, modified)

This European Standard 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, modifiziert)

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Withdrawn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
11-Aug-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/WG 4 - Tracheal tubes and other 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/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN 1820:2005+A1:2009 - Anaesthetic reservoir bags (ISO 5362:2000, modified)

Relations

Merged From
EN 1820:2005/prA1 - Anaesthetic reservoir bags (ISO 5362:2000, modified)
Effective Date
19-Jan-2023
Merged From
EN 1820:2005 - Anaesthetic reservoir bags (ISO 5362:2000, modified)
Effective Date
20-Jun-2009
Replaced By
EN ISO 5362:2019 - Anaesthetic reservoir bags (ISO 5362:2006)
Effective Date
25-Sep-2019

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dihalni baloni (ISO 5362:2000, spremenjen)Anästhesie-Reservoirbeutel (ISO 5362:2000, geändert)Ballons réservoirs d'anesthésie (ISO 5362:2000, modifiée)Anaesthetic reservoir bags (ISO 5362:2000, modified)11.040.10Anestezijska, respiratorna in reanimacijska opremaAnaesthetic, respiratory and reanimation equipmentICS:Ta slovenski standard je istoveten z:EN 1820:2005+A1:2009SIST EN 1820:2005+A1:2009en,fr,de01-oktober-2009SIST EN 1820:2005+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 1820:2005+A1
August 2009 ICS 11.040.10 Supersedes EN 1820:2005English 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 and includes Amendment 1 approved by CEN on 16 July 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 worldwide for CEN national Members. Ref. No. EN 1820:2005+A1:2009: ESIST EN 1820:2005+A1:2009

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
Principle . 12 B.2
Apparatus . 12 B.3
Procedure . 12 B.4
Expression of results . 12 Annex C (normative)
Test for security of attachment of plain neck to 22 mm male conical connector 13 C.1
Principle . 13 C.2
Apparatus and materials . 13 C.3
Procedure . 13 Annex D (normative)
Test for security of attachment of adaptor of assembled neck to bag . 14 D.2
Apparatus . 14 D.3
Procedure . 14 Annex E (normative)
Test for resistance to pressure required to distend the bag (pressure/volume) . 15 E.1
Principle . 15 E.2
Apparatus . 15 E.3
Procedure . 15 E.4
Expression of results . 15 Annex F (informative)
Test for resistance to pressure required to distend the bag using air (pressure/volume) . 16 F.1
Principle . 16 F.2
Apparatus . 16 SIST EN 1820:2005+A1:2009

Procedure . 16 F.4
Expression of results . 16 Annex G (informative)
Recommendations for materials . 17 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC Medical devices . 18 Bibliography . 20
...

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This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
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