1、BS EN ISO 80369-3:2016Small-bore connectors forliquids and gases in healthcareapplicationsPart 3: Connectors for enteral applications(ISO 80369-3:2016)BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06BS EN ISO 80369-3:2016 BRITISH STANDARDNational forewordThis British
2、 Standard is the UK implementation of EN ISO80369-3:2016.The UK participation 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 d
3、oes not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2016.Published by BSI Standards Limited 2016ISBN 978 0 580 83462 2ICS 11.040.25Compliance with a British Standard cannot confer immunity fromlegal
4、 obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 August 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 80369-3 August 2016 ICS 11.040.25 En
5、glish version Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications (ISO 80369-3:2016) Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant - Partie 3: Raccords destins des applications entrales (ISO 80369-3:
6、2016) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 3: Verbindungsstcke fr enterale Anwendungen (ISO 80369-3:2016) This European Standard was approved by CEN on 25 May 2016. CEN and CENELEC members are bound to comply with the CEN/CENELEC Inter
7、nal 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 any
8、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 notified to the CEN-CENELEC Management Centre has the same st
9、atus 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 Republic of Macedonia, France, Germany, Greece, Hungary, Icelan
10、d, 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 Brussels 2016 CEN/CENELEC All rights of exploitation in any form
11、 and by any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 80369-3:2016 EBS EN ISO 80369-3:2016EN ISO 80369-3:2016 (E) 3 European foreword This document (EN ISO 80369-3:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corre
12、sponding general aspects for medical devices” in collaboration with Technical Committee CEN-CENELEC/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
13、 by publication of an identical text or by endorsement, at the latest by February 2017, and conflicting national standards shall be withdrawn at the latest by February 2017. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/
14、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. For relationship with EU Direc
15、tive, 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 Republic, D
16、enmark, 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. Endorsement
17、 notice The text of ISO 80369-3:2016 has been approved by CEN as EN ISO 80369-3:2016 without any modification. 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) a
18、pplies. 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 st
19、ate-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 Z. NOTE The way in which these references documents are cite
20、d in normative requirements determines the extent (in whole or in part) to which they apply. BS EN ISO 80369-3:2016EN ISO 80369-3:2016 (E) 4 Table Correlations between normative references and dated EN and ISO/IEC standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO/
21、IEC ISO 5356-1:2004 EN ISO 5356-1:2004 ISO 5356-1:2004 ISO 5356-1:2015 EN ISO 5356-1:2015 ISO 5356-1:2015 ISO 5356-2:2006 EN ISO 5356-2:2007 ISO 5356-2:2006 ISO 5356-2:2012 EN ISO 5356-2:2012 ISO 5356-2:2012 ISO 8185:2007 EN ISO 8185:2009 ISO 8185:2007 EN 13544-2:2002 EN 13544-2:2002 EN 13544-2:2002
22、+A1:2009 EN 13544-2:2002+A1:2009 ISO 80369-1:2010 EN ISO 80369-1:2010 ISO 80369-1:2010 ISO 80369-6:2016 EN ISO 80369-6:2016 ISO 80369-6:2016 ISO 80369-7:aEN ISO 80369-7:aISO 80369-7:aISO 80369-20:2015 EN ISO 80369-20:2015 ISO 80369-20:2015 ASTM D638-10 ASTM D790-10 aTo be published. BS EN ISO 80369-
23、3:2016EN ISO 80369-3:2016 (E) 5 Annex ZA (informative) Relationship between this document 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 mea
24、ns 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
25、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 clause of this standard to the risk management process is made, the risk management process needs to be in c
26、ompliance 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)/subclause(s) of this Document Essential requirements (ERs) of EU Directive 93/42/EEC Qualifying remarks/
29、Notes 6.1 7.5 4.1, 5, 6.3, 6.4, 6.5, 6.6 9.1 6.2 12.7.4 4.1, 5, 6.3, 6.4, 6.5, 6.6 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 capabl
30、e 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 80369-3:2016EN ISO 80369-3:2016 (E) 6 For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/
31、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 correspondin
32、g 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 ma
33、chinery that are addressed by this document Clause(s)/subclause(s) of this Document EHSR of 2006/42/EC Qualifying remarks/Notes Clause 4, Clause 5, Clause 6 1.5.4 BS EN ISO 80369-3:2016ISO 80369-3:2016(E)Foreword ivIntroduction v1 * Scope . 12 Normative references 13 Terms and definitions . 24 Gener
34、al requirements . 34.1 General requirements for the enteral application. 34.2 Material used for enteral small-bore connectors . 34.3 Type tests . 45 Dimensional requirements for enteral small-bore connectors 46 Performance requirements . 46.1 Fluid leakage . 46.1.1 Fluid leakage requirement 46.1.2 L
35、eakage by pressure decay . 46.1.3 Positive pressure liquid leakage . 46.2 Stress cracking 46.3 Resistance to separation from axial load 46.4 Resistance to separation from unscrewing 56.5 Resistance to overriding . 56.6 Disconnection by unscrewing 5Annex A (informative) Rationale and guidance 6Annex
36、B (normative) Enteral small-bore connectors .10Annex C (normative) Reference connectors .16Annex D (informative) Assessment of medical devices and their attributes with connections within this application .21Annex E (informative) Summary of the usability requirements for small-bore connectors for en
37、teral applications .22Annex F (informative) Summary of small-bore connector criteria and requirements for enteral applications .27Annex G (informative) Summary of assessment of the design of the connectors for enteral applications .30Annex H (informative) Reference to the essential principles 36Anne
38、x I (informative) Terminology Alphabetized index of defined terms .38Bibliography .39 ISO 2016 All rights reserved iiiContents PageBS EN ISO 80369-3:2016ISO 80369-3:2016(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO mem
39、ber 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, governmen
40、tal and non-governmental, 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
41、are described in the 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
42、 drawn to the possibility 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
43、 on the ISO list of 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 asses
44、sment, as well as 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 dev
45、ices, and IEC/SC 62D, 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
46、2: Connectors for breathing systems and driving gases applications Part 3: Connectors for 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 P
47、art 20: Common test methodsAn additional part on connectors for urethral and urinary applications is planned.iv ISO 2016 All rights reservedBS EN ISO 80369-3:2016ISO 80369-3:2016(E)IntroductionThis part of ISO 80369 was developed because of several incidents, with catastrophic consequences, resultin
48、g from firstly, the administration of inappropriate medication into the alimentary canal and secondly, from enteral solutions being administered via incorrect routes, including intravenously and into the airway. Many incidents were reported leading to international recognition of the importance of t
49、hese issues, and a need was identified to develop specific connectors for medical devices and their accessories used to deliver feed via the enteral route.The ISO 80369 series has been developed to prevent misconnection between small-bore connectors used in different applications. ISO 80369-1 specifies the requirements necessary to verify the designs 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 80369-20 contains the
