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- Withdrawn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
- 20-Jan-2026
- 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
- 18-Sep-2019
- Completion Date
- 28-Jan-2026
Relations
- Effective Date
- 19-Jan-2023
- Effective Date
- 20-Jun-2009
- Effective Date
- 25-Sep-2019
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
- Effective Date
- 28-Jan-2026
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Frequently Asked Questions
EN 1820:2005+A1:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Anaesthetic reservoir bags (ISO 5362:2000, modified)". This standard covers: 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.
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.
EN 1820:2005+A1:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 1820:2005+A1:2009 has the following relationships with other standards: It is inter standard links to EN 1820:2005/prA1, EN 1820:2005, EN ISO 5362:2019, EN 556-1:2001, EN ISO 21920-2:2022, EN ISO 5356-1:2015, EN 792-6:2000+A1:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 1820:2005+A1:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 1820:2005+A1:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
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
For the purpose of this document, the flowrate of air required to maintain the specified internal gas pressure is assumed to equal the leakage rate. NOTE 2
A suitable test method is given in Annex A. This draws attention to the possible sites of leakage. 4.4 Capacity The actual capacity of the bag when tested in accordance with Annex B shall be the marked value, subject to a tolerance of ± 15 %. 4.5
Design 4.5.1 Neck 4.5.1.1 Necks shall be either plain or assembled. 4.5.1.2
Plain necks shall fit directly on to 22 mm male conical connectors complying with EN ISO 5356-1, or on to adaptors that fit 8,5 mm, 15 mm or 22 mm male conical connectors complying with EN ISO 5356-1. NOTE
Plain necks may be reinforced internally or externally or made of a material thicker than that of the bag. 4.5.1.3 Plain necks of bags intended to fit directly on to 22 mm male conical connectors shall have an axial length of not less than 26 mm from the open end, when measured in the unstretched condition. Plain necks shall not become detached from a 22 mm male conical connector when tested in accordance with Annex C. NOTE
Plain necks may be constructed to engage with the recess at the base of a 22 mm male conical connector. 4.5.1.4 Assembled necks shall incorporate an adaptor (see Figure 1) bearing a female conical connector in accordance with EN ISO
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