DIN EN ISO 80369-6-2016 Small bore connectors for liquids and gases in healthcare applications - Part 6 Connectors for neuraxial applications (ISO 80369-6 2016) German version EN I.pdf

1、November 2016 English price group 23No 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!%p“2587791www.din.deD

2、IN EN ISO 80369-6Small bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applications (ISO 803696:2016);English version EN ISO 803696:2016,English translation of DIN EN ISO 80369-6:2016-11Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gas

3、e in medizinischen Anwendungen Teil 6: Verbindungsstcke fr neuroaxiale Anwendungen (ISO 803696:2016);Englische Fassung EN ISO 803696:2016,Englische bersetzung von DIN EN ISO 80369-6:2016-11Raccords destins des applications en contact avec le systme nerveux (neuraxiales) Partie 6: Raccords destins de

4、s applications en contact avec le systme nerveux (neuraxiales) (ISO 803696:2016);Version anglaise EN ISO 803696:2016,Traduction anglaise de DIN EN ISO 80369-6:2016-11www.beuth.deDocument comprises 58 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be cons

5、idered authoritative.11.16 DIN EN ISO 80369-6:2016-11 2 A comma is used as the decimal marker. National 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 devices (Secretariat: ANSI, USA)

6、in collaboration with Technical Committee CEN/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 Commi

7、ttee NA 063-01-11 AA Kleinlumige Konnektoren 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 594-1 DIN EN 20594-1 ISO 3040 DIN EN ISO 3040 ISO 7886-1 DIN EN ISO 7886-1 ISO 8

8、185 DIN EN ISO 8185 ISO 14971 DIN EN ISO 14971 ISO 5356-1 DIN EN ISO 5356-1 ISO 5356-2 DIN EN ISO 5356-2 ISO 80369-1 DIN EN ISO 80369-1 ISO 80369-2 DIN EN ISO 80369-2 ISO 80369-3 DIN EN ISO 80369-3 ISO 80369-5 DIN EN ISO 80369-5 ISO 80369-7 DIN EN ISO 80369-7 ISO 80369-20 DIN EN ISO 80369-20 IEC 606

9、01-1 DIN EN 60601-1 (VDE 0750-1) IEC 60601-1-11 DIN EN 60601-1-11 (VDE 0750-1-11) IEC 62366-1 DIN EN 62366-1 (VDE 0750-241-1) CEN/CR 13825 DIN-Fachbericht 88 DIN EN ISO 80369-6:2016-11 3 National Annex NA (informative) Bibliography DIN EN 20594-1, Conical fittings with a 6 % (Luer) taper for syringe

10、s, needles and certain other medical equipment Part 1: General rules DIN EN 60601-1 (VDE 0750-1), Medical electrical equipment Part 1: General requirements for basic safety and essential performance DIN EN 60601-1-11 (VDE 0750-1-11), Medical electrical equipment Part 1-11: General requirements for b

11、asic safety and essential performance Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment DIN EN 62366-1 (VDE 0750-241-1), Medical devices Part 1: Application of usability engineering to medical devices DIN EN ISO

12、3040, Geometrical product specifications (GPS) Dimensioning and tolerancing Cones DIN EN ISO 5356-1, 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 co

13、nnectors DIN EN ISO 7886-1, Sterile hypodermic syringes for single use Part 1: Syringes for manual use 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 med

14、ical devices DIN EN ISO 80369-1, Small bore connectors for liquids and 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

15、EN ISO 80369-3, Small bore connectors for liquids and gases in healthcare applications Part 3: Connectors for enteral applications DIN EN ISO 80369-5, Small bore connectors for liquids and gases in healthcare applications Part 5: Connectors for limb cuff inflation applications DIN EN ISO 80369-7, Sm

16、all bore connectors for liquids and gases in healthcare applications 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

17、fittings DIN EN ISO 80369-6:2016-11 4 This page is intentionally blank 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 applications - Part 6: Connectors for neuraxial applications (ISO

18、 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 Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendu

19、ngen - 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 conditions for giving this European Standard the sta

20、tus 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 European Standard exists in three official versions (Englis

21、h, 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 and CENELEC members are the national standards bodies

22、 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, Luxembourg, Malta, Netherlands, Norway, Poland, Po

23、rtugal, 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 for CEN national Members and for CENELEC Members. R

24、ef. No. EN ISO 80369-6:2016 EEuropean foreword .3Introduction 81 * Scope 102 Normative references . 103 Terms and definitions 114 General requirements 124.1 General requirements for the neuraxial application 124.2 * Material used for small-bore connectors . 134.3 Type tests . 135 Dimensional require

25、ments for neuraxial small-bore connectors 136 Performance requirements 136.1 Fluid leakage 136.1.1 Fluid leakage requirement . 136.1.2 Leakage by pressure decay 136.1.3 Positive pressure liquid leakage 136.2 Subatmospheric pressure air leakage 146.3 Stress cracking . 146.4 Resistance to separation f

26、rom axial load. 146.5 Resistance to separation from unscrewing . 146.6 Resistance to overriding 14Annex A (informative) Rationale and guidance .5Annex B (normative) * Small-bore connectors for neuraxial applications .20Annex C (normative) Reference connectors for testing small-bore connectors for ne

27、uraxial applications 29Annex D (informative) Assessment of medical devices and their attributes with connections within this application .35Annex E (informative) Summary of the usability requirements for small-bore connectors for neuraxial applications .38Annex F (informative) Summary of small-bore

28、connector design requirements for neuraxial applications 39Annex G (informative) Summary of assessment of the design of the small bore connectors for neuraxial applications .42Annex H (normative) Mechanical tests for verifying non-interconnectable characteristics .46Annex I (informative) Reference t

29、o the essential principles 50Annex J (informative) Terminology alphabetized index of defined terms .52Bibliography .53ContentsEN ISO 80369-6:2016 (E) DIN EN ISO 80369-6:2016-11 2Foreword .7PageAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Dir

30、ective 93/42/EEC .15European 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 devices” in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding genera

31、l 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 by endorsement, at the latest by October 2016, and conflicting national standards shall be withdrawn at the l

32、atest 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 for identifying any or all such patent rights. This document has been prepared under a mandate given to CEN by

33、 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 is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standard

34、s 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, Luxem

35、bourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced documen

36、t (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 considered t

37、he 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, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way

38、in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. EN ISO 80369-6:2016 (E) DIN EN ISO 80369-6:2016-11 3 Table Correlation between normative references and dated EN and ISO standards Normative references as listed i

39、n 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 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

40、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 80369-5:1)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 80369-20:20

41、15 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. EN ISO 80369-6:2016 (E) DIN EN ISO 80369-6:2016-11 4 Annex ZA (informative) Relationship between this European Standard and the Es

42、sential 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 means of conforming to Essential Requirements of Directive 93/42/EEC on Medical Devices. Once this stan

43、dard 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 this standard confers, within the limits of the scope of this standard, a presumption of conformity

44、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 compliance with Directive 93/42/EEC / Directive 90/385/EEC, as amended by 2007/47/EC. This means that

45、 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 The manufacturers policy for determining acceptable risk must be in compliance with essential require

46、ments 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 Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this Euro

47、pean 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/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 Ess

48、ential 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 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. EN ISO 80369-6:2016 (E) DIN EN ISO 80369-6:2016-11 5 For devices which are also machinery