SIST 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 a etre utilisés avec les appareils d'anesthésie ou les systemes respiratoires
de ventilateurs pulmonaires. Elle fixe des prescriptions relatives a la conception du col, la désignation de la
taille, la distension et, le cas échéant, les prescriptions relatives a la résistance électrique.
Les ballons destinés a une utilisation spéciale, par exemple les soufflets ou les ballons a autodilatation, ne
sont pas traités dans le présent document. Les ballons destinés a etre utilisés avec les systemes d'évacuation
de gaz d'anesthésie en exces ne sont pas considérés comme des ballons réservoirs d'anesthésie, et ne
relevent donc pas du domaine d'application du présent document.
Dihalni baloni (ISO 5362:2000, spremenjen)
General Information
Relations
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 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
2
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SIST EN 1820:2005
EN 1820:2005 (E)
F.3 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
3
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SIST EN 1820:2005
EN 1820:2005 (E)
Foreword
The text of the International Standard ISO 5362:2000 from Technical Committee ISO/TC121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) has been taken over as a
European Standard by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat
of which is held by BSI, with common modifications which are indicated by a straight line in the margin of the text.
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 December 2005 and conflicting national standards shall be withdrawn at the latest
by December 2005.This document supersedes EN 1820:1997.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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.
4
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SIST EN 1820:2005
EN 1820:2005 (E)
Introduction
This European Standard is one of a series dealing with anaesthetic and respiratory equipment. This document is
primarily concerned with the design of the neck, size designation and resistance to pressure required to distend
anaesthetic reservoir bags.
The requirement that reservoir bags should be electrically conductive when used with a flammable anaesthetic is
widely recognized and is of particular importance when such bags are rhythmically compressed by the anaesthetic
provider in order to provide intermittent positive-pressure ventilation.
This European Standard gives requirements for both antistatic and non-antistatic bags. Only antistatic bags are
suitable for use with flammable anaesthetic agents.
This European Standard includes requirements for both single-use and reusable bags. Reusable bags are intended
to comply with the requirements of this document for the recommended product life.
The reference test method given as Annex E is not practical for routine use in manufacturing control, because it
involves filling the bag with water. For this reason, another test method using air rather than water has been
provided for information in Annex F. This may ultimately be suitable as the reference test method if it can be shown
to give results equivalent to Annex E.
A test method for leakage of bags using air rather than water is given as Annex A for information only.
Recommendations for materials are given in Annex G.
5
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SIST EN 1820:2005
EN 1820:2005 (E)
1 Scope
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
EN 556-1:2001, Sterilization of medical devices — Requirements for medical devices to be labelled “STERILE”
EN 980, Graphical symbols for use in the labelling of medical devices
EN 60601-1:1990, Medical electrical equipment — Part 1: General requirements for safety (IEC 60601-1:1988)
EN ISO 4287, Geometrical product specifications (GPS) — Surface texture: Profile method — Terms, definitions
and surface texture parameters (ISO 4287:1997)
EN ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets (ISO
5356-1:2004)
ISO 7000, Graphical symbols for use on equipment — Index and synopsis
ISO 11607, Packaging for terminally sterilized medical devices
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
anaesthetic reservoir bag
collapsible gas container which is a component in a breathing system
[EN ISO 4135:—]
3.2
assembled neck
neck incorporating an adaptor
3.3
adaptor
specialized connector to establish functional continuity between otherwise disparate or incompatible components,
one end of which is intended to be inserted into the neck of the bag, the other end having a conical connector
complying with EN ISO 5356-1
3.4
plain neck
neck designed to fit directly over a male conical connector complying with EN ISO 5356-1
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SIST EN 1820:2005
EN 1820:2005 (E)
3.5
tail
tubular extension of the bag at the end opposite to the neck
4 General requirements
4.1 Reusable bags
Reusable bags shall comply with the requirements of this document throughout the recommended product life as
given in Clause 8.
4.2 Size designation
The size of the bag shall be designated by the nominal capacity expressed in litres.
4.3 Leakage
-1
Bags of nominal capacity 1 l or less shall not leak at a rate of more than 10 ml·min at an internal overpressure of
(3 ± 0,3) kPa.
-1
Bags of nominal capacity greater than 1 l shall not leak at a rate of more than 25 ml·min at an internal
overpressure of (3 ± 0,3) kPa.
NOTE 1 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 fr
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