EN 1820-2005 en Anaesthetic reservoir bags (Incorporates Amendment A1 2009)《麻醉品储存袋 包含修改件A1-2009》.pdf

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1、BRITISH STANDARDBS EN 1820:2005+A1:2009Anaesthetic reservoir bagsICS 11.040.10g49g50g3g38g50g51g60g44g49g42g3g58g44g55g43g50g56g55g3g37g54g44g3g51g40g53g48g44g54g54g44g50g49g3g40g59g38g40g51g55g3g36g54g3g51g40g53g48g44g55g55g40g39g3g37g60g3g38g50g51g60g53g44g42g43g55g3g47g36g58National forewordThis

2、British Standard is the UK implementation of EN 1820:2005+A1:2009. It supersedes BS EN 1820:2005 which is withdrawn.The start and finish of text introduced or altered by amendment is indicated in the text by tags. Tags indicating changes to CEN text carry the number of the CEN amendment. For example

3、, text altered by CEN amendment A1 is indicated by !“.The UK participation in its preparation was entrusted by Technical Committee CH/121, Anaesthetic and respiratory equipment, to Subcommittee CH/121/5, Lung ventilators, tracheal tubes and related equipment.A list of organizations represented on th

4、is subcommittee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.Compliance with a British Standard cannot confer immunity from legal obligations.BS EN 1820:2005+A1:2

5、009This British Standard waspublished under the authorityof the Standards Policy andStrategy Committeeon 30 April 2007 BSI 2010Amendments/corrigenda issued since publicationDate Comments 31 March 2010 Implementation of CEN amendment A1:2009ISBN 978 0 580 65028 4EUROPEAN STANDARD NORME EUROPENNE EURO

6、PISCHE NORM EN 1820:2005+A1 August 2009 ICS 11.040.10 Supersedes EN 1820:2005English Version Anaesthetic reservoir 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

7、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 bibliographic

8、al 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

9、 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, It

10、aly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-10

11、00 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: 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 requir

12、ements 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 (nor

13、mative) 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

14、 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

15、 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 BS EN 1820:2005+A1:2009EN 1820:2005+A1:2009 (E) 3 F.3 Procedure 16 F.4 Expression of results . 16 Annex G (informative) Recommendation

16、s 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 BS EN 1820:2005+A1:2009EN 1820:2005+A1:2009 (E) 4 Foreword The text of the International Standard ISO 5362:2000 from T

17、echnical 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

18、 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

19、 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 2

20、005 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

21、 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 follow

22、ing 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, Slove

23、nia, Spain, Sweden, Switzerland and United Kingdom. BS EN 1820:2005+A1:2009EN 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 resi

24、stance 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

25、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 reu

26、sable 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 tes

27、t 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

28、only. Recommendations for materials are given in Annex G. BS EN 1820:2005+A1:2009EN 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 requ

29、irements 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 anaest

30、hetic 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 d

31、ocument (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 s

32、afety (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 700

33、0, 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

34、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

35、 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 BS EN 1820:2005+A1:2009EN 1820:2005+A1:2009 (E) 7 3.5 tail tubular extension of the bag at the end opposite to the neck 4 General requi

36、rements 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

37、 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 capacity 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 requ

38、ired 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

39、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

40、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 measu

41、red 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 a

42、n adaptor (see Figure 1) bearing a female conical connector in accordance with EN ISO 5356-1. The adaptor of the assembled neck shall not become detached from the bag when tested in accordance with Annex D. BS EN 1820:2005+A1:2009EN 1820:2005+A1:2009 (E) 8 Key 1 Neck of reservoir bag 2 Adaptor, whic

43、h may be flanged, grooved or recessed Figure 1Typical adaptor with (female) conical connector 4.5.2 Tail The tail, if open and 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 p

44、ressure 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 mea

45、sured capacity (i.e. capacity V1, see E.3.2) within a tolerance of 10 %. NOTE Another method for testing resistance to pressure to distend the bag, involving filling the bag with air rather than water, has been included for information as Annex F. 4.7 !Usability The manufacturer shall address in a u

46、sability engineering process the risk resulting from poor usability (see IEC 60601-1-6 / 62366). Check compliance by inspection of the usability engineering file. 4.8 Clinical evaluation A clinical evaluation shall be performed and documented in the risk management file. BS EN 1820:2005+A1:2009EN 18

47、20:2005+A1:2009 (E) 9 Check compliance by inspection of the risk management file. 4.9 Biophysical or modelling research Where appropriate, validated biophysical or modelling research shall be carried out. Check compliance by inspection of the technical file.“ 5 Prevention of electrostatic charges 5.

48、1 Antistatic bags shall comply with the requirements specified in EN 60601-1:1990, 39.3b. 5.2 Bags coloured black shall be antistatic and comply with 5.1. 6 Requirements for bags supplied sterile 6.1 Sterility assurance Bags supplied and marked as “STERILE” shall satisfy the requirements of EN 556-1

49、:2001, 4.1. 6.2 Packaging for bags supplied sterile Each bag supplied and marked as “STERILE” shall be contained in an individual pack. The pack shall serve as an effective barrier to the penetration of microorganisms and particulate material in accordance with ISO 11607. The pack shall permit the extraction of the contents and shall not be capable of reclosure without clearly revealing that it has been opened. NOTE The individual pack may also contain other breathing system components. 7 Marking 7.1 Use of symbols The