SIST EN 1820:2005+A1:2009

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



SIST EN 1820:2005+A1:2009



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



EN 1820:2005+A1:2009 (E) 2 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 SIST EN 1820:2005+A1:2009



EN 1820:2005+A1:2009 (E) 3 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
SIST EN 1820:2005+A1:2009



EN 1820:2005+A1:2009 (E) 4 Foreword The text of the International Standard ISO 5362:2000 from Technical Committee ISO/TC 121 “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 February 2010 and conflicting national standards shall be withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This European Standard was approved by CEN on 25 April 2005 and includes Amendment 1, approved by CEN on 16 July 2009. This document supersedes !EN 1820:2005". The start and finish of text introduced or altered by amendment is indicated in the text by tags !". 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, 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. SIST EN 1820:2005+A1:2009



EN 1820:2005+A1:2009 (E) 5 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. SIST EN 1820:2005+A1:2009



EN 1820:2005+A1:2009 (E) 6 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 SIST EN 1820:2005+A1:2009



EN 1820:2005+A1:2009 (E) 7 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 Bags of nominal capacity 1 l or less shall not leak at a rate of more than 10 ml·min-1 at an internal overpressure of (3 ± 0,3) kPa. Bags of nominal capacity greater than 1 l shall not leak at a rate of more than 25 ml·min-1 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 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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