DIN EN ISO 80369-3-2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3 Connectors for enteral applications (ISO 80369-3 2016) German version EN ISO.pdf

1、December 2016 English price group 21No 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 11.040.25!%I“2599138www.din.deD

2、IN EN ISO 80369-3Smallbore connectors for liquids and gases in healthcare applications Part 3: Connectors for enteral applications (ISO 803693:2016);English version EN ISO 803693:2016,English translation of DIN EN ISO 80369-3:2016-12Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase i

3、n medizinischen Anwendungen Teil 3: Verbindungsstcke fr enterale Anwendungen (ISO 803693:2016);Englische Fassung EN ISO 803693:2016,Englische bersetzung von DIN EN ISO 80369-3:2016-12Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant Partie 3: Raccords destins des appl

4、ications entrales (ISO 803693:2016);Version anglaise EN ISO 803693:2016,Traduction anglaise de DIN EN ISO 80369-3:2016-12www.beuth.deDocument comprises 51 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.02.17 DIN EN ISO 80369-3

5、:2016-12 2 A comma is used as the decimal marker. National foreword This document (EN ISO 80369-3:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” (Secretariat: ANSI, USA) in collaboration with Technical Committee CE

6、N/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” (Secretariat: NEN, Netherlands). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Working Committee NA 063-01-11 AA Kleinlumige Konnektoren

7、 fr Flssigkeiten und Gase zur Verwendung im Gesundheitsbereich. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 7886-1 DIN EN ISO 7886-1 ISO 8185 DIN EN ISO 8185 ISO 14971 DIN EN ISO 14971 ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN

8、ISO 5356-2 ISO 80369-1 DIN EN ISO 80369-1 ISO 80369-2 DIN EN ISO 80369-2 ISO 80369-5 DIN EN ISO 80369-5 ISO 80369-6 DIN EN ISO 80369-6 ISO 80369-7 DIN EN ISO 80369-7 ISO 80369-20 DIN EN ISO 80369-20 IEC 60601-1 DIN EN 60601-1 (VDE 0750-1) IEC 62366 DIN EN 62366 (VDE 0750-241) CEN/CR 13825 DIN-Fachbe

9、richt 88 National Annex NA (informative) Bibliography DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 62366 (VDE 0750-241), Medical devices Application of usability engineering to medical devices DIN EN ISO 5356

10、-1, Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets DIN EN ISO 5356-2, Anaesthetic and respiratory equipment Conical connectors Part 2: Screw-threaded weight-bearing connectors DIN EN ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manua

11、l use DIN EN ISO 80369-3:2016-12 3 DIN EN ISO 8185, Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN ISO 80369-1, Small bore connectors for liquids a

12、nd gases in healthcare applications Part 1: General requirements DIN EN ISO 80369-2, Small bore connectors for liquids and gases in healthcare applications Part 2: Connectors for breathing systems and driving gases applications DIN EN ISO 80369-5, Small bore connectors for liquids and gases in healt

13、hcare applications Part 5: Connectors for limb cuff inflation applications DIN EN ISO 80369-6, Small bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applications DIN EN ISO 80369-7, Small bore connectors for liquids and gases in healthcare applicatio

14、ns Part 7: Connectors with 6% (Luer) taper for intravascular or hypodermic applications DIN EN ISO 80369-20, Small bore connectors for liquids and gases in healthcare applications Part 20: Common test methods DIN-Fachbericht 88, Luer fittings DIN EN ISO 80369-3:2016-12 4 This page is intentionally b

15、lank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80369-3 August 2016 ICS 11.040.25 English 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 utili

16、ss dans le domaine de la sant - Partie 3: Raccords destins des applications entrales(ISO 80369-3:2016) 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 appro

17、ved by CEN on 25 May 2016. CEN and 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

18、national standards may be obtained 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 CENEL

19、EC member into its own language and 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,

20、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 United Kingdom. CEN-CENELEC Management

21、Centre: Avenue Marnix 17, B-1000 Brussels 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 80369-3:2016 EForeword .7Introduction 81 * Scope . 92 Normative references 93 Terms and definitions

22、104 General requirements 114.1 General requirements for the enteral application 114.2 Material used for enteral small-bore connectors 114.3 Type tests 125 Dimensional requirements for enteral small-bore connectors . 126 Performance requirements 126.1 Fluid leakage 126.1.1 Fluid leakage requirement .

23、 126.1.2 Leakage by pressure decay 126.1.3 Positive pressure liquid leakage 126.2 Stress cracking . 126.3 Resistance to separation from axial load. 126.4 Resistance to separation from unscrewing . 136.5 Resistance to overriding 136.6 Disconnection by unscrewing . 13Annex A (informative) Rationale an

24、d guidance . 14Annex B (normative) Enteral small-bore connectors .18Annex C (normative) Reference connectors .24Annex D (informative) Assessment of medical devices and their attributes with connections within this application .29Annex E (informative) Summary of the usability requirements for small-b

25、ore connectors for enteral applications .30Annex F (informative) Summary of small-bore connector criteria and requirements for enteral applications .35Annex G (informative) Summary of assessment of the design of the connectors for enteral applications .38Annex H (informative) Reference to the essent

26、ial principles 44Annex I (informative) Terminology Alphabetized index of defined terms .46Bibliography .47Contents PageEuropean foreword 3 Annex ZA (informative) Relationship between this document and the Essential Requirements of EU Directive 93/42/EEC 5 .DIN EN ISO 80369-3:2016-12 EN ISO 80369-3:2

27、016 (E)2 European foreword This document (EN ISO 80369-3:2016) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” in collaboration with Technical Committee CEN-CENELEC/TC 3 “Quality management and corresponding general aspec

28、ts 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 by endorsement, at the latest by February 2017, and conflicting national standards shall be withdrawn at the latest

29、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/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

30、European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organi

31、zations 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, Luxembourg, M

32、alta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement 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 indisp

33、ensable 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

34、 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 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 standa

35、rd or dated ISO standard, as outlined below, including the foreword and the Annexes Z. NOTE The way in which these references documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. DIN EN ISO 80369-3:2016-12 EN ISO 80369-3:2016 (E)3 Table Corre

36、lations between normative references and dated EN and ISO/IEC standards Normative references as listed in Clause 2 Equivalent dated standard EN ISO/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:

37、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+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

38、: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. DIN EN ISO 80369-3:2016-12 EN ISO 80369-3:2016 (E)4 Annex ZA (informative) Relationship between this document and the Essential Requirements of EU Directive 93/42/EEC T

39、his European Standard has been prepared under a 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 Eur

40、opean Union under that Directive and has been implemented 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

41、 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 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”,

42、“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 and 12 of the direc

43、tive. 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 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

44、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/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

45、 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 capable of controlling the flowrate. WARNING Other requirements and other EU Directives may be applicable to the products falling within the scope of this

46、 document. DIN EN ISO 80369-3:2016-12 EN ISO 80369-3:2016 (E)5 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 r

47、equirements 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 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

48、 presumption of conformity for the machinery directive. 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)/subclause(s) of this Document EHSR of 2006/42/EC Qualifying remarks/Notes Clause 4, Clause 5, Clause 6 1.5.4 DIN EN ISO 80369-3:2016-12 EN ISO 80369-3:2016 (E)6