1、January 2017 English price group 14No part of this translation 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!%_-“2605910www.din.deD
2、IN EN ISO 5364Anaesthetic and respiratory equipment Oropharyngeal airways (ISO 5364:2016);English version EN ISO 5364:2016,English translation of DIN EN ISO 5364:2017-01Ansthesie und Beatmungsgerte Oropharyngealtuben (ISO 5364:2016);Englische Fassung EN ISO 5364:2016,Englische bersetzung von DIN EN
3、ISO 5364:2017-01Matriel danesthsie et de ranimation respiratoire Canules oropharynges (ISO 5364:2016);Version anglaise EN ISO 5364:2016,Traduction anglaise de DIN EN ISO 5364:2017-01SupersedesDIN EN ISO 5364:201107See start of applicationwww.beuth.deDocument comprises 27 pagesDTranslation by DIN-Spr
4、achendienst.In case of doubt, the German-language original shall be considered authoritative.01.17 DIN EN ISO 5364:2017-01 2 A comma is used as the decimal marker. Start of application The start of application of this standard is 2017-01-01. For DIN EN ISO 5364:2011-07 there is a transition period e
5、nding on 2019-09-30. National foreword This document (EN ISO 5364:2016) has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment” (Secretariat: ANSI, USA) in collaboration with Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” (Secretariat: BSI,
6、 United Kingdom) with the active participation of German experts. The responsible German body involved in its preparation was DIN-Normenausschuss Rettungsdienst und Krankenhaus (DIN Standards Committee Rescue Services and Hospital), Working Committee NA 053-03-02 AA Medizinprodukte fr das Atemwegssy
7、stem. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 4135 DIN EN ISO 4135 ISO 7000 DIN ISO 7000 ISO 10993-1 DIN EN ISO 10993-1 ISO 11607-1 DIN EN ISO 11607-1 ISO 15223-1 DIN EN 15223-1 Amendments This standard differs from DIN EN ISO 5
8、364:2011-07 as follows: a) the legibility requirement for marking has been revised; b) a unique colour marking for tubes has been specified; c) the requirement for marking of tubes in the presence of natural rubber (latex) has been included; d) an informative Annex “Rationale” regarding some importa
9、nt requirements has been included; e) an informative Annex ZA “Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC” regarding medical devices has been included; f) the standard has been editorially revised. Previous editions DIN EN 12181: 1998-04 DIN
10、EN ISO 5364: 2011-07 DIN EN ISO 5364:2017-01 3 National Annex NA (informative) Bibliography DIN ISO 7000, Graphical symbols for use on equipment Index and synopsis DIN EN ISO 4135, Anaesthetic and respiratory equipment Vocabulary DIN EN ISO 10993-1, Biological evaluation of medical devices Part 1: E
11、valuation and testing within a risk management system DIN EN ISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems DIN EN ISO 15223-1, Medical devices Symbols to be used with medical device labels, labelling
12、 and information to be supplied Part 1: General requirements DIN EN ISO 5364:2017-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 5364 September 2016 ICS 11.040.10 Supersedes EN ISO 5364:2011English Version Anaesthetic and respiratory equipment - Oropha
13、ryngeal 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 CEN on 15 July 2016. CEN members are bound to comply with the CEN/CENELEC
14、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-CENELEC Management Centre or to
15、 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-CENELEC Management Centre has the same status as the officia
16、l 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, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, No
17、rway, 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 Management Centre: Avenue Marnix 17, B-1000 Brussels 2016 CEN All rights of exp
18、loitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 5364:2016 EForeword 8Introduction 91 Scope 102 Normative references . 103 Terms and definitions 104 Size designation and dimensions . 114.1 Size designation 114.2 Dimensions 125 Materials 126 Design .
19、 127 Performance requirements 127.1 Resistance to collapse of the buccal portion 127.2 Patency of lumen 128 Sterility assurance . 139 Packaging of oropharyngeal airways supplied sterile . 1310 Marking . 1310.1 General 1310.2 Use of symbols 1310.3 Marking of oropharyngeal airways 1310.4 Marking of un
20、it packs . 1410.5 Marking of shelf or multi-unit packs . 1511 Information to be supplied by the manufacturer 15Annex A (informative) Rationale . 16Annex B (normative) Test method for resistance to collapse of the buccal portion 18Annex C (normative) Test method for patency of lumen 20Annex D (inform
21、ative) Guidance on materials and design .22Bibliography .23Contents PageEuropean foreword 3 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC 5 .DIN EN ISO 5364:2017-01 EN ISO 5364:2016 (E) 2 European foreword This document (E
22、N ISO 5364:2016) has been prepared by Technical 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 nat
23、ional standard, either by publication of 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 pat
24、ent rights. CEN and/or CENELEC shall not 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 essenti
25、al requirements of EU Directive(s). For 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 doc
26、ument (including any amendments) applies. 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 consid
27、ered the generally acknowledged state-of-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
28、these references documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. DIN EN ISO 5364:2017-01 EN ISO 5364:2016 (E) 3 EN 556-1:2001 EN 556-1:2001 1 The graphical symbols in ISO 7000 are also available on line in the ISO web store. For more inf
29、ormation, 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, Belgium, Bulgaria, Croatia, Cyprus, Czech Re
30、public, 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, Switzerland, Turkey and the United Kingdom. En
31、dorsement notice The text of ISO 5364:2016 has been approved by CEN as EN ISO 5364:2016 without any modification. N1)National footnote: The standard ISO 4135 is referenced in the Bibliography. N2)National footnote: It should read EN ISO 15223-1. The new editions of ISO 15223-1 and EN ISO 15223-1 are
32、 in preparation. 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 ISO 7000:2014 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 1160
33、7-1 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006 + AMD 1:2014 ISO 15223-1 EN 15223-1:1ISO 15223-1:20151N1)N2)DIN EN ISO 5364:2017-01 EN ISO 5364:2016 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Stan
34、dard 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 title of any other standardization request a
35、s 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 Directive, compliance with the normative clauses
36、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 of this standard to the risk management p
37、rocess 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 to the wording of the corresponding essent
38、ial 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 of references in the European foreword, rep
39、lacing 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/EEC OJ L 169 Essential Requirements of Dire
40、ctive 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 9.1 9.2 9.2 Covered on for packaging of s
41、terile devices. 8.3 9.3 Partly addressed by 9.3 which mandates the requirements of ISO 11607-1 that the DIN EN ISO 5364:2017-01 EN ISO 5364:2016 (E) 5 packaging is suitable to prevent contamination during transportation and use. 8.7 9.1 Partly covered. Marked sterile if appropriate 9.2 (first two in
42、dents) 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 requirement to limit sharp edges. 13.1 9
43、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 ER fully, the strong recommendation t
44、o 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 fully, the recommendation to provide the
45、 method of sterilisation is mandatory (if applicable). 13.6 h) (firs paragraph only) 11.1 DIN EN ISO 5364:2017-01 EN ISO 5364:2016 (E) 6 WARNING 1 Presumption of conformity stays valid only as long as a reference to this European Standard is maintained in the list published in the Official Journal o
46、f 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. DIN EN ISO 5364:2017-01 EN ISO 5364:2016 (E)
47、7 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 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 E
