BS EN ISO 5364-2016 Anaesthetic and respiratory equipment Oropharyngeal airways《麻醉剂和呼吸设备 口咽导气管》.pdf

1、BS EN ISO 5364:2016Anaesthetic and respiratoryequipment Oropharyngealairways (ISO 5364:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 5364:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5364:2016. It sup

2、ersedes BS EN ISO 5364:2011 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Airways and related equipment.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to i

3、nclude all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 82787 7 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal obligations.Th

4、is British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2016.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5364 September 2016 ICS 11.040.10 Supersedes EN I

5、SO 5364:2011English Version Anaesthetic and respiratory equipment - Oropharyngeal airways (ISO 5364:2016) Matriel danesthsie et de ranimation respiratoire - Canules oropharynges (ISO 5364:2016) Ansthesie- und Beatmungsgerte - Oropharyngealtuben (ISO 5364:2016) This European Standard was approved by

6、CEN on 15 July 2016. 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

7、 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 its own language and notifi

8、ed 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Icel

9、and, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Manag

10、ement Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5364:2016 EBS EN ISO 5364:2016EN ISO 5364:2016 (E) 3 European foreword This document (EN ISO 5364:2016) has been prepared by T

11、echnical Committee ISO/TC 121 “Anaesthetic and respiratory equipment“ in collaboration with 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 o

12、f an identical text or by endorsement, at the latest by March 2017, and conflicting national standards shall be withdrawn at the latest by September 2019. 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 no

13、t be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 5364:2011. 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

14、 relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applie

15、s. For dated references, only the edition cited applies. However, for any use of this standard “within the meaning of Annex ZA“, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-o

16、f-art. When the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a normative reference to the parallel EN standard or dated ISO standard, as outlined below, including the foreword and the Annexes ZZ. NOTE The way in which these references documents are cited in

17、 normative requirements determines the extent (in whole or in part) to which they apply. Table Correlations between normative references and dated EN and ISO/IEC standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO/IEC ISO 4135 EN ISO 4135:2001 ISO 4135:2001 ISO 7000

18、 ISO 7000:2014 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 11607-1 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006 + AMD 1:2014 ISO 15223-1 EN 15223-1:1ISO 15223-1:20151BS EN ISO 5364:2016EN ISO 5364:2016 (E) 4 EN 556-1:2001 EN 556-1:2001 1 The graphical symbols in ISO 7000 are also availabl

19、e on line in the ISO web store. For more information, consult http:/www.iso.org/iso/publications_and_e-products/databases.htm?=. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria,

20、Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Sw

21、itzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5364:2016 has been approved by CEN as EN ISO 5364:2016 without any modification. BS EN ISO 5364:2016EN ISO 5364:2016 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of

22、 EU Directive 93/42/EEC This European Standard has been prepared under a Commissions standardization request M/023 concerning the development of European Standards related to medical devices / M/295 concerning the development of European Standards related to medical devices / reference number and ti

23、tle of any other standardization request as relevant to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 160. Once this standard is cited in the Official Journal of the European Union under that Directi

24、ve, compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive and associated EFTA regulations. NOTE 1 Where a reference from a clause

25、 of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This means that risks have to be reduced as far as possible, to a minimum, to the lowest possible level, minimized or removed, according

26、to the wording of the corresponding essential requirement. NOTE 2 The manufacturers policy for determining acceptable risk must be in compliance with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive. NOTE 3 This Annex ZA is based on normative references according to the table o

27、f references in the European foreword, replacing the references in the core text. NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this European Standard. Table ZA.1 Correspondence between this European Standard and Annex I of Directive 93/42/E

28、EC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.1 (second indent) 5 10.3.1 c) 10.4 C) Partly covered. There are no requirements for materials apart from a requirement to indicate the presence of natural rubber (latex), if applicable. 8.1 8

29、 9.1 9.2 9.2 Covered on for packaging of sterile devices. 8.3 9.3 Partly addressed by 9.3 which mandates the requirements of ISO 11607-1 that the BS EN ISO 5364:2016EN ISO 5364:2016 (E) 6 packaging is suitable to prevent contamination during transportation and use. 8.7 9.1 Partly covered. Marked ste

30、rile if appropriate 9.2 (first two indents) 4 6 7 Partly covered to address only the risk of injury in connection with their physical features by specifying sizing and marking conventions for the length and ID of the airway and by testing for collapse and patency. 12.7.1 6 Partly covered with a requ

31、irement to limit sharp edges. 13.1 9 10 11 13.2 10.3.3 10.3.4 Covered only for the use of identification colours. 13.3 b) 10.3.1 a) 10.3.3 10.5 a) 10.5 b) 13.3 c) 10.4 a) 10.5 e) 13.3 d) 10.5 d) To cover this ER fully, the batch number must be preceded by the word LOT. 13.3 e) 10.5 f) To cover this

32、ER fully, the strong recommendation to state the use by date is mandatory. 13.3 f) 10.4 b) 10.5 f) Only the first sentence is covered. 13.3 k) 10.3.1 c) 10.4 b) 10.4 c) 10.5 f) Limited to indications only of single use and the presence of natural rubber (latex). 13.3 m) 10.5 e) To cover th is ER ful

33、ly, the recommendation to provide the method of sterilisation is mandatory (if applicable). 13.6 h) (firs paragraph only) 11.1 BS EN ISO 5364:2016EN ISO 5364:2016 (E) 7 WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained in the list pub

34、lished in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2 Other Union legislation may be applicable to the products falling within the scope of this standard. BS EN ISO 536

35、4:2016ISO 5364:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Size designation and dimensions 24.1 Size designation . 24.2 Dimensions . 35 Materials . 36 Design 37 Performance requirements . 37.1 Resistance to collapse of the buccal portion . 37.2 Pat

36、ency of lumen . 38 Sterility assurance 49 Packaging of oropharyngeal airways supplied sterile 410 Marking 410.1 General . 410.2 Use of symbols . 410.3 Marking of oropharyngeal airways . 410.4 Marking of unit packs 510.5 Marking of shelf or multi-unit packs 611 Information to be supplied by the manuf

37、acturer . 6Annex A (informative) Rationale 7Annex B (normative) Test method for resistance to collapse of the buccal portion . 9Annex C (normative) Test method for patency of lumen 11Annex D (informative) Guidance on materials and design .13Bibliography .14 ISO 2016 All rights reserved iiiContents P

38、ageBS EN ISO 5364:2016ISO 5364:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body

39、interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotech

40、nical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO d

41、ocuments should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held respon

42、sible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given f

43、or the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following UR

44、L: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment.This fifth edition cancels and replaces the fourth edition (ISO 5364:2008), which has been technically revised.Thr

45、oughout this International Standard, text for which rationale is provided in Annex A is indicated by an asterisk (*).Major changes in this edition include new legibility test methods and requirements and a colour code to indicate designated size.iv ISO 2016 All rights reservedBS EN ISO 5364:2016ISO

46、5364:2016(E)IntroductionThis International Standard specifies dimensions and other requirements for oropharyngeal airways.Airway size is designated by length, which is important when selecting an oropharyngeal airway to hold forward the base of the tongue to prevent obstruction of the airway by the

47、soft tissues.Airway size is indicated by a legible marking and by a colour code, which are important to allow rapid identification and selection in emergencies. ISO 2016 All rights reserved vBS EN ISO 5364:2016BS EN ISO 5364:2016Anaesthetic and respiratory equipment Oropharyngeal airways1 ScopeThis

48、International Standard specifies requirements for oropharyngeal airways of plastics materials and/or rubber, including those with a reinforcement insert made of plastics materials and/or metal.This International Standard is not applicable to metal oropharyngeal airways, nor to requirements concernin

49、g flammability of oropharyngeal airways.Flammability of oropharyngeal airways, for example, if flammable anaesthetics, electrosurgical units, or lasers are used, is a well-recognized hazard. It is addressed by appropriate clinical management, which is outside the scope of this International Standard.This International Standard is not applicable to supralaryngeal airways without an internal, integral sealing mechanism.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this