1、December 2009DEUTSCHE NORM English price group 12No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.10!$2,“1561509
2、www.din.deDDIN EN 1820Anaesthetic reservoir bags (ISO 5362:2000, modified) (includes Amendment A1:2009)English version of DIN EN 1820:2009-12Ansthesie-Reservoirbeutel (ISO 5362:2000, modifiziert) (enthlt nderung A1:2009)Englische Fassung DIN EN 1820:2009-12SupersedesDIN EN 1820:2005-09See start of v
3、aliditywww.beuth.deDocument comprises pages22DIN EN 1820:2009-12 Start of validity This standard takes effect on 1 December 2009. DIN EN 1820:2005-09 may be used in parallel until 21 March 2010. National foreword This standard has been prepared by Technical Committee CEN/TC 215 “Respiratory and anae
4、sthetic equipment” (Secretariat: BSI, United Kingdom). The responsible German body involved in its preparation was the Normenausschuss Rettungsdienst und Krankenhaus (Rescue Services and Hospital Standards Committee), Technical Committee NA 053-03-02 AA Trachealtuben.Based on the results of the uniq
5、ue acceptance procedure, ISO 5362:2000 has been adopted as a European Standard with common modifications which are indicated by a vertical line in the margin of the text. This European Standard includes Amendment A1:2009 approved by CEN on 16 July 2009. The start and finish of text introduced or alt
6、ered by amendment is indicated in the text by tags !“. This standard contains specifications meeting the essential requirements set out in EU Directive 93/42/EEC on medical devices. Amendments This standard differs from DIN EN 1820:2005-09 as follows: a) The following clauses, subclauses and Annexes
7、 have been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices an
8、d EU Directive 98/8/EC on the placing on the market of biocidal products: 1) Subclauses 4.7 (usability ), 4.8 (clinical evaluation) and 4.9 (biophysical or modelling research) have been revised. to include the requirement that if phthalates are incorporated in medical devices coming into contact wit
9、h the patient, these devices are to be labelled accordingly by the manufacturer. 2) Subclause 7.3 has been revised to include the requirement that for single use devices the manufacturer shall disclose in the instructions for use the risks associated with reuse. 3) The information to be supplied by
10、the manufacturer specified in clause 8 has been supplemented. 4) The requirement has been included that if phthalates are incorporated in medical devices coming into contact with the patient, these devices are to be labelled accordingly. 5) Table ZA.1 (Correspondence between clauses/subclauses of th
11、is standard and the essential requirements of Directive 93/42/EEC on medical devices) has been revised. Previous editions DIN EN 1820: 1997-11, 2005-09 2 EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 1820:2005+A1 August 2009 ICS 11.040.10 Supersedes EN 1820:2005English Version Anaesthetic res
12、ervoir bags (ISO 5362:2000, modified) Ballons rservoirs danesthsie (ISO 5362:2000, modifie) Ansthesie-Reservoirbeutel (ISO 5362:2000, gendert) 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 th
13、e 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
14、 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
15、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, Sloveni
16、a, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR 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 nati
17、onal Members. Ref. No. EN 1820:2005+A1:2009: EEN 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
18、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 Expressi
19、on 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
20、.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 (
21、pressure/volume) . 16 F.1 Principle 16 F.2 Apparatus . 16 DIN EN 1820:2009-12 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 Requi
22、rements of EU Directive 93/42/EEC Medical devices . 18 Bibliography 20 DIN EN 1820:2009-12 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 Standa
23、rdization (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 g
24、iven 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
25、 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
26、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
27、 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, D
28、enmark, 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. DIN EN 1820:2009-12 EN 1820:2005+A1:2009 (E) 5 Introduction Th
29、is 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 elec
30、trically 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 an
31、tistatic 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 l
32、ife. 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
33、 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. DIN EN 1820:2009-12 EN 1820:2005+A1:2009 (E) 6 1 Scope This
34、 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 d
35、ocument 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 do
36、cuments 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 dev
37、ices 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, de
38、finitions 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 devi
39、ces 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
40、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 co
41、nical connector complying with EN ISO 5356-1 DIN EN 1820:2009-12 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 prod
42、uct 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 mlmin-1at an internal overpressure of (3 0,3) kPa. Bags of nominal capaci
43、ty greater than 1 l shall not leak at a rate of more than 25 mlmin-1at 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
44、 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 Plai
45、n 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
46、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
47、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 5356-1. The adaptor of the assembled
48、neck shall not become detached from the bag when tested in accordance with Annex D. DIN EN 1820:2009-12 EN 1820:2005+A1:2009 (E) 8 Key 1 Neck of reservoir bag 2 Adaptor, which may be flanged, grooved or recessed Figure 1Typical adaptor with (female) conical connector 4.5.2 Tail The tail, if open and
49、 not provided with a closure mechanism, shall have a minimum length of 20 mm. NOTE A loop for suspending the bag may be provided near the tail of the bag. 4.6 Resistance to pressure required to distend the bag (pressure/volume) 4.6.1 When tested in accordance with Annex E (see E.3.6), the final pressure head shall be not less than 3,0 kPa and not more than 6,0 kPa. 4.6.2 A bag tested in accordance with Annex E shall revert within 30 min of the test to its previously measured capacity (i.e. capacity V1, see E.3.2) with
