EN ISO 5364-2011 7500 Anaesthetic and respiratory equipment - Oropharyngeal airways《麻醉和呼吸设备 口咽导气管》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 5364:2011Anaesthetic and respiratoryequipment Oropharyngealairways (ISO 5364:2008)Copyright European Committee for Standardization Provided by IHS under license with CE

2、NNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5364:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5364:2011.It is identical to ISO 5364:2008. It supersedes BS EN 12181:1998 whichis withdrawn.The UK partic

3、ipation in its preparation was entrusted to TechnicalCommittee CH/121/5, Lung ventilators, tracheal tubes and relatedequipment.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of

4、a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 72271 4ICS 11.040.10Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August

5、2011.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5364 April 2011

6、 ICS 11.040.10 Supersedes EN 12181:1998English Version Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2008) Matriel danesthsie et de ranimation respiratoire - Canules oropharynges (ISO 5364:2008) Ansthesie- und Beatmungsgerte - Oropharyngealtuben (ISO 5364:2008) This Europea

7、n Standard was approved by CEN on 24 March 2011. 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 concer

8、ning such national standards may be obtained on application to the CEN-CENELEC 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

9、 its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Irelan

10、d, Italy, 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,

11、 B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5364:2011: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted with

12、out license from IHS-,-,-BS EN ISO 5364:2011EN ISO 5364:2011 (E) 3 Foreword The text of ISO 5364:2008 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 5364:2011 by

13、 Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the secretariat of which is held by BSI. 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 October 2011, and conflicting natio

14、nal standards shall be withdrawn at the latest by October 2011. This document supersedes EN 12181:1998. 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 su

15、ch patent rights. 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, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary

16、, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 5364:2008 has been approved by CEN as a EN ISO 5364:2011 without any modification

17、. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5364:2011ISO 5364:2008(E) ISO 2008 All rights reserved iiiContents Page1 Scope 12 Normative references 13 Terms and de

18、finitions 14 Size designation and dimensions 25 Materials . 36 Design . 37 Performance requirements . 38 Sterility assurance . 49 Packaging of oropharyngeal airways supplied sterile . 410 Marking . 411 Information to be supplied by the manufacturer 5Annex A (normative) Test method for resistance to

19、collapse of the buccal portion . 6Annex B (normative) Test method for patency of lumen 8Annex C (informative) Guidance on materials and design . 10Bibliography . 11Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permi

20、tted without license from IHS-,-,-BS EN ISO 5364:2011ISO 5364:2008(E)iv ISO 2008 All rights reservedForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies(ISO member bodies). The work of preparing International Standards is normally ca

21、rried out through ISOtechnical committees. Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. I

22、SO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare Internationa

23、l Standards. Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements

24、 of this document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 5364 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,Subcommittee SC 2, Tracheal tubes and other equipment.This fourth editi

25、on cancels and replaces the third edition (ISO 5364:2001), which has been technically revised.In this corrected version of ISO 5364:2008 Figure 1 has been replaced with an illustration in which the positiongiven in key 3 is corrected.Copyright European Committee for Standardization Provided by IHS u

26、nder license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5364:2011ISO 5364:2008(E) ISO 2008 All rights reserved vIntroductionThis International Standard specifies dimensions and other requirements for oropharyngeal airways.Airway size is desig

27、nated by length, which is important when selecting an oropharyngeal airway to hold forwardthe base of the tongue to prevent obstruction of the airway by the soft tissues.Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking

28、 permitted without license from IHS-,-,-BS EN ISO 5364:2011.viCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5364:2011INTERNATIONAL STANDARD ISO 5364:2008(E) ISO 2008

29、All rights reserved 1Anaesthetic and respiratory equipment Oropharyngeal airways1ScopeThis International Standard specifies requirements for oropharyngeal airways of plastics materials and/orrubber, including those with a reinforcement insert made of plastics materials and/or metal.This Internationa

30、l Standard is not applicable to metal oropharyngeal airways, nor to requirements concerningflammability of oropharyngeal airways.Flammability of oropharyngeal airways, for example if flammable anaesthetics, electrosurgical units or lasersare used, is a well-recognized hazard. It is addressed by appr

31、opriate clinical management, which is outside thescope of this International Standard.This International Standard is not applicable to supralaryngeal airways without an internal, integral sealingmechanism.2 Normative referencesThe following referenced documents are indispensable for the application

32、of this document. For datedreferences, only the edition cited applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO 7000, Graphical symbols for use on equipment Index and synopsisISO 10993-1, Biological evaluation of medical devices Part

33、 1: Evaluation and testing within a riskmanagement processISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterilebarrier systems and packaging systemsEN 556-1:2001, Sterilization of medical devices Requirements for medical devices to be designated

34、“STERILE” Part 1: Requirements for terminally sterilized medical devicesEN 980, Graphical symbols for use in the labelling of medical devicesEN 1041, Information supplied by the manufacturer with medical devices3 Terms and definitionsFor the purposes of this document, the following terms and definit

35、ions apply.3.1 oropharyngeal airwaydevice intended to maintain a gas pathway through the oral cavity and pharynxISO 4135Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO

36、5364:2011ISO 5364:2008(E)2 ISO 2008 All rights reserved3.2 pharyngeal endthat end of an oropharyngeal airway which is intended to be inserted into a patients oropharynxISO 41353.3 flanged endthat end of an oropharyngeal airway which is flanged and is intended to be external to the teeth or gumsISO 4

37、1354 Size designation and dimensions4.1 Size designationThe size of oropharyngeal airways shall be designated by the nominal length (see , Figure 1) expressed incentimetres, in accordance with Table 1.NOTE The manufacturers own size designation may additionally be given, but this is not recommended.

38、Key1 buccal portion2 reinforcement insert, if provided3 position for measuring minimum inside dimension (see Table 1)4 flanged endaFor see 4.1 and 4.2.1.Figure 1 Dimensions for size designation of oropharyngeal airwaysllCopyright European Committee for Standardization Provided by IHS under license w

39、ith CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5364:2011ISO 5364:2008(E) ISO 2008 All rights reserved 34.2 Dimensions4.2.1 The length (see , Figure 1) shall be in accordance with Table 1.4.2.2 The minimum inside dimension at any point along the le

40、ngth of the airway shall be not less than thatspecified in Table 1.NOTE This dimension is relevant to the ability to pass other devices, e.g. a suction catheter, through the airway.5 MaterialsOropharyngeal airways, in their ready-for-use state after any preparation for use recommended by themanufact

41、urer, shall satisfy appropriate biological safety testing, as indicated in ISO 10993-1.6 DesignEdges and corners intended to come into contact with the patients tissues shall have a minimum radius ofcurvature of .7 Performance requirements7.1 Resistance to collapse of the buccal portionWhen tested i

42、n accordance with Annex A, the minimum inside dimension of the buccal portion of the airwayshall be not less than of that given in Table 1 for the size of the airway being tested.7.2 Patency of lumenWhen tested in accordance with Annex B, the patency of the oropharyngeal airway lumen shall be mainta

43、ined.Table 1 Size designation of oropharyngeal airways Dimensions and tolerancesDesignated size (nominal length)Length and toleranceMinimum inside dimension32,53,5 3,04304,5 3,0535,5 3,564,6,5 4,07408459410 5,011 5,512 5,5cm mm mm30 2,535 2,540 2,545 2,550 2,555 2,560 2,565 2,570+5,02,580 5,090 5,01

44、00 5,0110 5,0120 5,0l0,5 mm75 %Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 5364:2011ISO 5364:2008(E)4 ISO 2008 All rights reserved8 Sterility assuranceOropharyngeal

45、 airways supplied and marked “STERILE” shall satisfy the requirements of 4.1 ofEN 556-1:2001.9 Packaging of oropharyngeal airways supplied sterile9.1 Each oropharyngeal airway supplied and marked “STERILE” shall be contained in an individual pack.9.2 The pack shall serve as an effective barrier to t

46、he penetration of micro-organisms and particulate materialin accordance with ISO 11607-1.9.3 The pack shall permit the aseptic extraction of the contents and shall not be capable of re-closure withoutclearly revealing that it has been opened.9.4 The designated size of the airway shall be apparent on

47、 visual examination of the intact unit container.9.5 Individual packs shall be contained within a shelf or multi-unit pack.10 Marking10.1 GeneralMarking of oropharyngeal airways, of unit packs and of shelf or multi-unit packs and information to be suppliedby the manufacturer should comply with EN 10

48、41.10.2 Use of symbolsThe requirements of 10.4 and 10.5 may be met by use of appropriate symbols as given in ISO 7000 or EN 980.10.3 Marking of oropharyngeal airways10.3.1 The flanged end of the oropharyngeal airway shall be marked with the following:a) the designated size (nominal length, in centimetres) in accordance with 4.1 (see Figure 2);b) the name and/or trade mark of the manufacturer and/or supplier (see Figure 2).10.3.2 Markings in accordance with a) and b) shall