1、BSI Standards PublicationBS EN ISO 80369-6:2016Small bore connectors forliquids and gases in healthcareapplicationsPart 6: Connectors for neuraxialapplicationsBS EN ISO 80369-6:2016 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO80369-6:2016.The UK participa
2、tion in its preparation was entrusted to TechnicalCommittee CH/210/5, Small Bore Connectors for Medical Devices.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 a contract. Use
3、rs are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 83999 3ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of t
4、heStandards Policy and Strategy Committee on 30 April 2016.Amendments/corrigenda issued since publicationDate Text affectedEUROPEAN 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 applications
5、- Part 6: Connectors for neuraxial applications (ISO 80369-6:2016) Raccords destins des applications en contact avec le systme nerveux (neuraxiales) - Partie 6: Raccords destins des applications en contact avec le systme nerveux (neuraxiales) (ISO 80369-6:2016) Verbindungsstcke mit kleinem Durchmess
6、er fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 6: Verbindungsstcke fr neuroaxiale Anwendungen (ISO 80369-6:2016) This European Standard was approved by CEN on 20 February 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the
7、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 any CEN and CENELEC member. This Europea
8、n 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 notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN a
9、nd CENELEC members are the national standards bodies and national electrotechnical committees 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
10、, 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 Brussels 2016 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide
11、 for CEN national Members and for CENELEC Members. Ref. No. EN ISO 80369-6:2016 EBS EN ISO 80369-6:2016EN ISO 80369-6:2016 (E) 3 European foreword This document (EN ISO 80369-6:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical
12、 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 standard, either by publication of an identical text or
13、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. CEN and/or CENELEC shall not be held responsible f
14、or 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 with EU Directive, see informative Annex ZA, which i
15、s 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 Republic, Denmark, Estonia, Finland, Former Yugosl
16、av 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. The following referenced documents are indispensab
17、le 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 meaning of Annex ZA, the user should always check
18、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 normative reference to the corresponding EN standard
19、, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 80369-6:2016EN ISO 80369-6:2016 (E) 4 Table
20、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 5356-1:2015 ISO 5356-1:2015 ISO 5356-2:2006 EN 5356-2:2007
21、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 80369-3:1)ISO 80369-3:1)ISO 80369-5:1)EN 80369-5:
22、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 has been approved by CEN as EN ISO 80369-6:2016 without any modification. BS EN ISO 80369-6:2016EN I
23、SO 80369-6:2016 (E) 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 mandate given to CEN by the European Commission and the European Free Trade Association to provide a mean
24、s 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 implemented as a national standard in at least one Member State, compliance with the normative clauses of t
25、his 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 clause of this standard to the risk management process is made, the risk management process needs to be in co
26、mpliance 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“, “minimized“ or “removed“, according to the wording of the corresponding essential requirement. NOTE 2 Th
27、e 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 Table of References, replacing the references in the core text. NOTE 4 When an
28、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)/sub-clause(s) of this Document Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks
29、/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 can only be connected to intended MEDICAL DEVICES or ACCESSORIES it permits a MEDICAL DEVICE to be capab
30、le of controlling the flowrate. WARNING: Other requirements and other EU Directives may be applicable to the products falling within the scope of this document. BS EN ISO 80369-6:2016EN ISO 80369-6:2016 (E) 6 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/4
31、2/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 to the extent to which they are more specific than those of Directive 93/42/EEC along with the correspond
32、ing 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 directive. Table ZA.2 Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/EC on
33、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 BS EN ISO 80369-6:2016ISO 80369-6:2016(E)Foreword ivIntroduction v1 * Scope . 12 Normative references 13 Terms and definitions . 24 General requirements .
34、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 Performance requirements . 46.1 Fluid leakage . 46.1.1 Fluid leakage requirement 46.1.2 Leakage by pressure dec
35、ay . 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 from unscrewing 56.6 Resistance to overriding . 5Annex A (informative) Rationale and guidance 6Annex B (normative
36、) * Small-bore connectors for neuraxial applications .11Annex C (normative) Reference connectors for testing small-bore connectors for neuraxial applications 20Annex D (informative) Assessment of medical devices and their attributes with connections within this application .26Annex E (informative) S
37、ummary of the usability requirements for small-bore connectors for neuraxial applications .27Annex F (informative) Summary of small-bore connector design requirements for neuraxial applications 30Annex G (informative) Summary of assessment of the design of the small bore connectors for neuraxial app
38、lications .33Annex H (normative) Mechanical tests for verifying non-interconnectable characteristics .37Annex I (informative) Reference to the essential principles 41Annex J (informative) Terminology alphabetized index of defined terms .43Bibliography .44 ISO 2016 All rights reserved iiiContents Pag
39、eBS 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 work of preparing International Standards is normally carried out through ISO technical committees. Each member b
40、ody 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 Electro
41、technical 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 I
42、SO 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 possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held r
43、esponsible 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 g
44、iven 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 information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the follow
45、ing URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC62D, Electromedical equipment. The draft was circulated for voting to the national bodies of both ISO and IEC.IS
46、O 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 enteral applications Part 5: Connectors for limb cuff inflation applications Part 6: Connectors for neuraxial a
47、pplications 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 applications is planned.iv ISO 2016 All rights reservedBS EN ISO 80369-6:2016ISO 80369-6:2016(E)IntroductionThis par
48、t 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 recognition of the importance of these iss
49、ues and a need has been identified to develop specific connectors for medical devices and their accessories used to deliver fluids in other applications.The ISO 80369 series was developed to prevent misconnection between small-bore connectors used in different applications. ISO 80369-1 specifies the requirements necessary to verify the designs and dimensions of small-bore connectors to ensure thata) they do not misconnect with other small-bore connectors, andb) they safely and securely connect with their mating half.ISO 803
