BS EN ISO 80369-6-2016 Small bore connectors for liquids and gases in healthcare applications Connectors for neuraxial applications《医疗保健设施中液体与气体用小型孔连接器 椎管内应用连接器》.pdf

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1、BS EN ISO 80369-6:2016Small bore connectors forliquids and gases in healthcareapplicationsPart 6: Connectors for neuraxialapplicationsIncorporating corrigendum February 2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 80369-6:2016 BRITISH STANDARDNationa

2、l forewordThis British Standard is the UK implementation of EN ISO80369-6:2016.The UK participation in its preparation was entrusted by TechnicalCommittee CH/210, Quality management and corresponding A list of organizations represented on this subcommittee can beobtained on request to its secretary.

3、This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2017.Published by BSI Standards Limited 2017ISBN 978 0 580 97528 8ICS 11.040.25Compliance with a British Standard cannot confer

4、immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 April 2016.Amendments/corrigenda issued since publicationDate Text affectedImplementation of ISO corrected text 15 November 2016: cross-reference in Subclause 6.

5、3 corrected28 February 2017Small Bore Connectors for Medical Devices.general aspects for medical devices, to Subcommittee CH/210/5,EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80369-6 April 2016 ICS 11.040.25 English version Small bore connectors for liquids and gases in healthcare appli

6、cations - Part 6: Connectors for neuraxial applications (ISO 80369-6:2016, Corrected version 2016-11-15) Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant - Partie 6: Raccords destins des applications en contact avec le systme nerveux (neuraxiales) (ISO 80369-6:2016,

7、Version corrige 2016-11-15) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 6: Verbindungsstcke fr neuroaxiale Anwendungen (ISO 80369-6:2016, korrigierte Fassung 2016-11-15) This European Standard was approved by CEN on 20 February 2016. CEN and

8、CENELEC 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 may be obtained

9、on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC 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 and CENELEC member into its own language and

10、 notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav R

11、epublic 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 United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Br

12、ussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 80369-6:2016 EEuropean foreword This document (EN ISO 80369-6:2016) has been prepared by Technical Committee ISO/TC 210 “Quality manage

13、ment and corresponding general aspects for medical devices” in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standa

14、rd, either by publication of an identical text or by endorsement, at the latest by October 2016, and conflicting national standards shall be withdrawn at the latest by October 2016. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.

15、CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. 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 relationship wi

16、th EU Directive, 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 following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech

17、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, Switzerland, Turkey and the United Kingdom.

18、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) applies. For dated references, only the edition cited applies. However, for any use of this standard within the

19、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-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a no

20、rmative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. iiBS EN ISO 80369-6:2016EN ISO 80369-6:2016 (E) NOTE The way in which these referenced documents are cited in normative requirements determines the extent

21、 (in whole or in part) to which they apply. Table Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 5356-1:2004 EN 5356-1:2004 ISO 5356-1:2004 ISO 5356-1:2015 EN 5356-1:20

22、15 ISO 5356-1:2015 ISO 5356-2:2006 EN 5356-2:2007 ISO 5356-2:2006 ISO 5356-2:2012 EN 5356-2:2012 ISO 5356-2:2012 ISO 8185:2007 EN 8185:2009 ISO 8185:2007 EN 13544-2:2002 EN 13544-2:2002 EN 13544-2:2002+A1:2009 EN 13544-2:2002+A1:2009 ISO 80369-1:2010 EN 80369-1:2010 ISO 80369-1:2010 ISO 80369-3:1)EN

23、 80369-3:1)ISO 80369-3:1)ISO 80369-5:1)EN 80369-5:1)ISO 80369-5:1)ISO 80369-7:1)EN 80369-7:1)ISO 80369-7:1)ISO 80369-20:2015 EN 80369-20:1)ISO 80369-20:2015 ASTM D638-10 ASTM D790-10 1 To be published. Endorsement notice The text of ISO 80369-6:2016, Corrected version 2016-11-15 has been approved by

24、 CEN as EN ISO 80369-6:2016 without any modification. iiiBS EN ISO 80369-6:2016EN ISO 80369-6:2016 (E) EN ISO 80369-6:2016 (E) 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

25、mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of Directive 93/42/EEC on Medical Devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been im

26、plemented as a national standard in at least one Member State, compliance with the normative clauses of this standard confers, within the limits of the scope of this standard, a presumption of conformity with the relevant Essential Requirements of that Directive. NOTE 1 Where a reference from a clau

27、se of this standard to the risk management process is made, the risk management process needs to be in compliance with Directive 93/42/EEC / Directive 90/385/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“,

28、 “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 and 12 of the directive. NOTE 3 This Annex ZA is based on Normativ

29、e References according to Table of References, 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 document and Directive 93/42/EEC Clause(s)

30、/sub-clause(s) of this Document Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/Notes 6.2 7.5 4.1, 5, 6.4, 6.5, 6.6, 6.7 9.1 6.3 12.7.4 4.1, 5, 6.2, 6.5, 6.6, 6.7 12.8.1 This Essential Requirement is partially covered in that by ensuring that the CONNECTOR does not leak and

31、 can only be connected to intended MEDICAL DEVICES or ACCESSORIES it permits a MEDICAL DEVICE to be capable of controlling the flowrate. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this document. ivBS EN ISO 80369-6:2016EN ISO 803

32、69-6:2016 (E) For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery, in accordance with Article 3 of Directive 93/42/EEC the following Table ZA.2 details the relevant essential health and safety requirements of Directive 2006/42/EC on Machinery

33、to the extent to which they are more specific than those of Directive 93/42/EEC along with the corresponding clauses of this Document. Table ZA.2, however, does not imply any citation in the OJEU under the machinery directive and thus does not provide presumption of conformity for the machinery dire

34、ctive. Table ZA.2 Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on machinery that are addressed by this document Clause(s)/sub-clause(s) of this Document EHSR of 2006/42/EC Qualifying remarks/Notes 4, 5, 6 1.5.4 vBS EN ISO 80369-6:2016ISO 80369-6:2016(E)Foreword

35、 . viiIntroduction viii1 * Scope . 12 Normative references 13 Terms and definitions . 24 General requirements . 34.1 General requirements for the neuraxial application . 34.2 * Material used for small-bore connectors 44.3 Type tests 45 Dimensional requirements for neuraxial small-bore connectors. 46

36、 Performance requirements . 46.1 Fluid leakage . 46.1.1 Fluid leakage requirement 46.1.2 Leakage by pressure decay . 46.1.3 Positive pressure liquid leakage . 46.2 Subatmospheric pressure air leakage . 56.3 Stress cracking 56.4 Resistance to separation from axial load 56.5 Resistance to separation f

37、rom unscrewing 56.6 Resistance to overriding . 5Annex A (informative) Rationale and guidance 6Annex B (normative) * Small-bore connectors for neuraxial applications .11Annex C (normative) Reference connectors for testing small-bore connectors for neuraxial applications 20Annex D (informative) Assess

38、ment of medical devices and their attributes with connections within this application .26Annex E (informative) Summary of the usability requirements for small-bore connectors for neuraxial applications .27Annex F (informative) Summary of small-bore connector design requirements for neuraxial applica

39、tions 30Annex G (informative) Summary of assessment of the design of the small bore connectors for neuraxial applications .33Annex H (normative) Mechanical tests for verifying non-interconnectable characteristics .37Annex I (informative) Reference to the essential principles 41Annex J (informative)

40、Terminology alphabetized index of defined terms .43Bibliography .44 ISO 2016 All rights reserved viContents PageBS EN ISO 80369-6:2016ISO 80369-6:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The wo

41、rk 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-governm

42、ental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical 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 th

43、e ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents 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 poss

44、ibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible 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 o

45、f patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for 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

46、 information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC6

47、2D, Electromedical equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.ISO 80369 consists of the following parts, under the general title Small-bore connectors for liquids and gases in healthcare applications: Part 1: General requirements Part 3: Connectors for

48、enteral applications Part 5: Connectors for limb cuff inflation applications Part 6: Connectors for neuraxial applications Part 7: Connectors with 6 % (Luer) taper for intravascular or hypodermic applications Part 20: Common test methodsAn additional part on connectors for urethral and urinary appli

49、cations is planned.This corrected version of ISO 80369-6:2016 incorporates the following correction: in 6.3, the cross-reference to 6.1.2 has been changed to 6.1.1.vii ISO 2016 All rights reservedBS EN ISO 80369-6:2016ISO 80369-6:2016(E)IntroductionThis part of ISO 80369 was developed because of several incidents, with catastrophic consequences, resulting from inappropriate medication, liquid nutritional formula, or air being administered neuraxially. Many incidents have been reported leading to international recognit