EN ISO 5361-2016 en Anaesthetic and respiratory equipment - Tracheal tubes and connectors《麻醉和呼吸设备-气管导管和连接器第二版(ISO 5361 2016)》.pdf

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1、BS EN ISO 5361:2016Anaesthetic and respiratoryequipment Tracheal tubesand connectors (ISO 5361:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 5361:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 5361:2016

2、. It supersedes BS EN ISO 5361:2012 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/121/5, Airways and related equipment.A list of organizations represented on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 purp

3、ort to include 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 82786 0 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal obliga

4、tions.This 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 5361 September 2016 ICS 11.040.10 Superse

5、des EN ISO 5361:2012English Version Anaesthetic and respiratory equipment - Tracheal tubes and connectors (ISO 5361:2016) Matriel danesthsie et de ranimation respiratoire - Sondes trachales et raccords (ISO 5361:2016) Ansthesie- und Beatmungsgerte - Trachealtuben und Verbindungsstcke (ISO 5361:2016)

6、 This European Standard was approved by 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 refer

7、ences concerning 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

8、 member into 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, Former Yugoslav Republic of Macedonia

9、, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCH

10、ES KOMITEE FR NORMUNG CEN-CENELEC Management 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 5361:2016 EBS EN ISO 5361:2016EN ISO 5361:2016 (E) 3 European foreword This document (E

11、N ISO 5361:2016) 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

12、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

13、ent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 5361:2012. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essenti

14、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

15、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

16、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

17、these references documents are cited in 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 594-1

18、 EN 20594-1:1993 + AC:1993 + A1:1997 ISO 594-1:1986 ISO 5356-1 EN ISO 5356-1:2015 ISO 5356-1:2015 ISO 70001ISO 7000:2014 ISO 10993-1 EN ISO 10993-1:2009 ISO 10993-1:2009 ISO 11135 EN ISO 11135:20104 ISO 11135:2014 BS EN ISO 5361:2016EN ISO 5361:2016 (E) 4 ISO 11137-1 EN ISO 11137-1:2015 ISO 11137-1:

19、2006 + AMD 1:2013 ISO 11607-1 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006 + AMD 1:2014 ISO 14155 EN ISO 14155:2011 ISO 14155:2011 + CORR 1:2011 ISO 14971 EN ISO 14971:2012 ISO 14971:2007 ISO 15223-1 EN 15223-1:1ISO 15223-1:20151ISO 15223-2 ISO 15223-2:2010 EN 556-1:2001 EN 556-1:2001 EN 1041 EN 1

20、041:2008 + A1:2013 ASTM F640-2007 ASTM D3002-2007 1 The graphical symbols in ISO 7000 are also available 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 stan

21、dards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, L

22、uxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 5361:2016 has been approved by CEN as EN ISO 5361:2016 without any modification. BS EN ISO 5361:2016EN ISO 5361:2016 (E)

23、 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of 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/29

24、5 concerning the development of European Standards related to medical devices / reference number and title 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

25、 OJ L 160. Once this standard is cited in the Official Journal of the European Union under that Directive, 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

26、 requirements of that Directive and associated EFTA regulations. NOTE 1 Where a reference from a clause 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 r

27、educed as far as possible, to a minimum, to the lowest possible level, minimized or removed, according 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

28、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, 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 Europ

29、ean Standard. Table ZA.1 Correspondence between this International Standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requirements of Directive 93/42/EEC Clause(s)/sub-clause(s) of this EN Remarks/Notes 7.1 (2nd indent) 7.1 (3rd indent) 5.3 4.1.6 7.1 (second indent) Partly Covered. There

30、 are no requirements for materials apart for e requirements to perform a risk assessment. 7.2 5.3.1 7.1 7.2 7.1 and 7.2 covers the integrity of the packaging only for devices supplied sterile. 7.3 5.3.1 5.3.3 5.3.1 and 5.3.1 First part covered; does not cover devices intended to BS EN ISO 5361:2016E

31、N ISO 5361:2016 (E) 6 administer medicinal products. 7.5 (second paragraph) 5.3.4 8.3.1 m) 8.1 7.2 Covered only for packaging of sterile devices. 8.3 7.2 Partly addressed by 7.2 which mandates the requirements of ISO 11607-1 that the packaging is suitable to prevent contamination during transportati

32、on and use. 8.4 7.1 7.1 mandates that sterile devices satisfy 4.1 of EN 556-1. 8.7 8.3.1 h) Partly covered. Marked sterile if appropriate. 9.1 5.2.2 Generally covered by mandating construction and testing of the interface connector. 9.2 (first and second indent) 5.1 5.2 Tables 1a), 1b), and 1c) 5.5

33、5.7 6 8.3.2 b) Partly covered to address only the risk of injury in connection with their physical features by specifying sizing and marking conventions for the ID/OD of the tracheal tube, curvature of the tube, marking for the OD of the cuff, and pressure limits for cuff performance testing. 10.1 (

34、first sentence) 8.2.1.1 d) Partly covered to address length measurement and marking in cm. 10.2 8.2.1.1 d) 8.2.1.2 Partly addressed. Length marking positions are mandated to provide ergonomic angular visibility during intubation. Glottic depth marks aid in intubation positioning. 10.3 8.2.1.1 d), an

35、d e) Length marking is mandated using SI units (cm). 12.7.4 5.2.2.5 5.6.5 Tracheal tube gas connectors are mandated to comply with ISO 5356-1 for 15 mm connectors. Tracheal tube cuff inflation BS EN ISO 5361:2016EN ISO 5361:2016 (E) 7 connectors are mandated to comply with ISO 594-1 for Luers. 13.1

36、8 Covered by mandating marking and labelling and instructions on the tube, connector, unit label, and instructions for use. 4.2.1 13.3 b) 7.2 8.3.1 b) 8.3.1 c) 8.3.1 d) 8.3.1 h) Only identifies that the device is sterile (if applicable). Marking of 8.3.1 b), c) and d) on the unit pack will further a

37、ddress this requirement. 13.3 c) 8.3.1 h) 13.3 d) 8.3.1 g) Batch code preceded by the word “LOT” mandated for EU countries. 13.3 e) 8.3.1 g) Use by date is only addressed via a strong recommendation; The EU regulation makes it mandatory. 13.3 f) 8.3.1 i) For full coverage of this ER, the NOTE in 8.1

38、.1 I) is mandatory. 13.3 j) 4.2.1 NOTE 4.2.1 Safety note draws attention to consideration of disclosure of specific labelling and instructions for intended use that may deviate from the currently accepted medical practice. This NOTE is mandatory to cover this ER. 13.3 m) 8.3.1 h) NOTE This NOTE is m

39、andatory to cover this ER. 13.5 8.4 Limited to detachable connectors, which are marked with the designated tracheal tube size. 13.6, a) 8 Covers the following details referred to in section 13.3 13.3a), b), c), f), and j). For 13.3 m) to be covered the recommendation in 8.3.1 h) is mandatory. BS EN

40、ISO 5361:2016EN ISO 5361:2016 (E) 8 13.6, b) 8 Covered in full 13.6, c) 5.2.2.5 8.3.1 b) 8.3.1 b) requires the description of the contents. Per 5.2.2.5 the connector is mandated to be a 15mm male connector. 13.6 h), first and second paragraphs 8.3.1 l) Mandated instructions for cleaning and disinfec

41、tion or sterilization. Risks associated with the reuse of devices marked for single use are covered partly by the risk management file and use of the informative Annex F Hazard identification for risk assessment 13.6 i) 8.3.2 a) Details for preparation for use are mandated for disclosure. 13.6 q) 8.

42、3.2 c) The date of issue of the latest revision of instructions for use is mandated. 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 of the European Union. Users of this standard should

43、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. NOTE Where a reference from a clause of this standard to the risk management process is made, the

44、 risk management process needs to be in compliance to the Medical Devices Directive 93/42/EEC. 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 essential requirement

45、. BS EN ISO 5361:2016ISO 5361:2016(E)Foreword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 24 *General requirements for tracheal tubes and tracheal tube connectors . 54.1 Risk assessment . 54.2 Safety . 65 Specific requirements for tracheal tubes and tracheal tube con

46、nectors . 65.1 Size designation . 65.2 Dimensions . 65.2.1 Tracheal tubes 65.2.2 Tracheal tube connectors 105.3 *Materials . 135.4 Tracheal tube bevel 135.5 *Tracheal tube cuffs . 135.6 Inflating system for cuffs . 145.7 Curvature of the tube 145.8 *Radiopaque marker . 165.9 *Kink resistance 166 Add

47、itional requirement for tracheal tubes with a Murphy eye 176.1 Size of the Murphy eye 176.2 Location of the Murphy eye 176.3 Resistance to kinking or collapse of the Murphy eye 176.4 Surface characteristics of the Murphy eye . 177 Requirements for tracheal tubes with tracheal tube connectors supplie

48、d sterile .177.1 Sterility assurance . 177.2 Packaging for tracheal tubes and tracheal tube connectors supplied sterile 188 Marking .188.1 Use of symbols 188.2 Marking on the tracheal tube 188.3 Marking on the tracheal tube individual pack or any insert.198.4 Marking on tracheal tube connectors 21An

49、nex A (informative) Rationale .22Annex B (normative) Determination of cuff diameter 26Annex C (normative) Test method for cuffed tube collapse 27Annex D (normative) *Test method for cuff herniation 30Annex E (informative) Guidance on design of tracheal tube connectors .32Annex F (informative) Hazard identification for risk assessment .33Annex G (normative) *Test method for tracheal seal .36Annex H (normative) Test method to determine kink resistance.39Bibliography .41 ISO 2016 All rights reserved iiiContents PageBS EN