EN ISO 80369-7-2017 en Small-bore connectors for liquids and gases in healthcare applications - Part 7 Connectors for intravascular or hypodermic applications.pdf

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1、Small-bore connectors for liquids and gases in healthcare applicationsPart 7: Connectors for intravascular or hypodermic applicationsBS EN ISO 80369-7:2017Incorporating Corrigendum September 2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06EUROPEAN STANDARD NORME

2、EUROPENNE EUROPISCHE NORM EN ISO 80369-7 May 2017 ICS 11.040.25 Supersedes EN 1707:1996, EN 20594-1:1993 English version Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016) Raccords de petite tail

3、le pour liquides et gaz utiliss dans le domaine de la sant - Partie 7: Raccords 6 % (Luer) destins aux applications intravasculaires ou hypodermiques (ISO 80369-7:2016) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 7: Verbindungsstcke mit einem

4、 6% (Luer) Kegel fr intravaskulre oder hypodermische Anwendungen (ISO 80369-7:2016) This European Standard was approved by CEN on 21 May 2017. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the st

5、atus 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 (Engli

6、sh, 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 bodie

7、s 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, P

8、ortugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 CEN/CENELEC All rights of exploitation in any form and by any means reserved worldwide for CEN national Members and for CENELEC M

9、embers. Ref. No. EN ISO 80369-7:2017 ENational forewordThis British Standard is the UK implementation of EN ISO 80369-7:2017. It is identical to ISO 80369-7:2016. It supersedes BS EN 20594-1:1994 (dual numbered as ISO 594-1:1986) and BS EN 1707:1997 which are withdrawn.The UK participation in its pr

10、eparation was entrusted to Technical Committee CH/210/5, Small Bore Connectors for Medical Devices.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are resp

11、onsible for its correct application. The British Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 51630 6ICS 11.040.25Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Stand

12、ards Policy and Strategy Committee on 31 July 2017.Amendments/corrigenda issued since publicationDate Text affected 30 September 2017 Supersession details updatedBRITISH STANDARDBS EN ISO 80369-7:2017EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80369-7 May 2017 ICS 11.040.25 Supersedes E

13、N 1707:1996, EN 20594-1:1993 English version Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016) Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant - Partie 7: Racco

14、rds 6 % (Luer) destins aux applications intravasculaires ou hypodermiques (ISO 80369-7:2016) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 7: Verbindungsstcke mit einem 6% (Luer) Kegel fr intravaskulre oder hypodermische Anwendungen (ISO 80369-

15、7:2016) This European Standard was approved by CEN on 21 May 2017. 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 bib

16、liographical 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 (English, French, German). A version in any other language made by translation und

17、er 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 and national electrotechnical committees of Austria, Belgium, Bulgaria, Cr

18、oatia, 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, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Tu

19、rkey and United Kingdom. CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2017 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 80369-7:2017 EBS EN ISO 80369-7:2017EN ISO 80369-7:2

20、017 (E) 3 European foreword The text of ISO 80369-7:2016 has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general aspects for medical devices” of the International Organization for Standardization (ISO) and has been taken over as EN ISO 80369-7:2017 by Techni

21、cal 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 by endorsement, at the latest by Novem

22、ber 2017, and conflicting national standards shall be withdrawn at the latest by May 2020. 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 rig

23、hts. This document supersedes EN 1707:1996, EN 20594-1:1993. 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(s), see informative

24、 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, Denmark, Estonia, Finl

25、and, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. The following referenced

26、 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 meaning of Annex ZA“, t

27、he 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 the ISO or IEC standard is referred to in the ISO text standard, this must be understood as a normative reference to t

28、he parallel EN standard or dated ISO standard, as outlined below, including the foreword and the Annexes ZZ. 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. BS EN ISO 80369-7:2017EN ISO 80369-7:2017

29、 (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/IEC ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007 ISO 5356-1:2004 EN 5356-1:2004 ISO 5356-1:2004 ISO 5356-1:2015 EN 5356-1:2015 ISO

30、5356-1:2015 ISO 5356-2:2006 EN 5356-2:2007 ISO 5356-2:2006 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 ISO 80

31、369-1:2010 ISO 80369-1:2010 ISO 80369-3:2015 EN ISO 80369-3:2016 ISO 80369-3:2015 ISO 80369-6:2015 EN ISO 80369-6:2016 ISO 80369-6:2015 ISO 80369-20:2015 EN 80369-20:2015 ISO 80369-20:2015 ASTM D638-10 ASTM D790-10 Endorsement notice The text of ISO 80369-7:2016 has been approved by CEN as EN ISO 80

32、369-7:2017 without any modification. BS EN ISO 80369-7:2017EN ISO 80369-7:2017 (E) 5 Annex ZA (informative) Relationship between this European standard and the essential requirements of Directive 93/42/EEC OJ L 169 aimed to be covered This European standard has been prepared under a Commissions stan

33、dardisation request M/0231to provide one voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169. Once this standard is cited in the Official Journal of the European Union under that Directive, compliance with the nor

34、mative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding essential requirements of that Directive, and associated EFTA regulations. NOTE 1 Where a reference from a clause of this standard to the r

35、isk management process is made, the risk management process needs to be in compliance with Directive 93/42/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 corr

36、esponding 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 normative references according to the table of references in the Europe

37、an foreword, 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 European standard and Annex I of Directive 93/42/EEC OJ L 169 Essential Requ

38、irements of Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Remarks / Notes 7.5 6.1, 6.2 Only the first sentence of ER 7.5 is met as it relates to the leakage of a connection. 9.1 5, 6.3, 6.4, 6.5, 6.6 ER 9.1 is met with respect to the connector dimensions, resistance to stress cracking, di

39、sconnection, unscrewing and overriding of threads or lugs only. 12.7.4 6.3 ER 12.7.4 is met with respect to stress cracking only. 1Replace with M/023 concerning the development of European standards related to medical devices or with M/295 concerning the development of European standards related to

40、medical devices, or with the reference number and title of any other standardization request as relevant. BS EN ISO 80369-7:2017EN ISO 80369-7:2017 (E) 6 Essential Requirements of Directive 93/42/EEC Clause(s) / sub-clause(s) of this EN Remarks / Notes 12.8.1 4.1, 5, 6.2, 6.4, 6.5, 6.6 ER 12.8.1 is

41、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 1: Presumption of conformity stays valid only as long as a reference to this Euro

42、pean standard is maintained in the list published in the Official Journal of the European Union. Users of this standard should consult frequently the latest list published in the Official Journal of the European Union. WARNING 2: Other Union legislation may be applicable to the product(s) falling wi

43、thin the scope of this standard. BS EN ISO 80369-7:2017This page deliberately left blank ISO 80369-7:2016(E)Foreword ivIntroduction vi1 * Scope . 12 Normative references 13 Terms and definitions . 24 General requirements . 34.1 General requirements for luer connectors 34.2 Material used for luer con

44、nectors . 44.3 Type tests . 45 * Dimensional requirements for luer connectors . 46 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 Sub-atmospheric pressure air leakage . 56.3 Stress cra

45、cking 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) luer connectors .10Annex C (normative) Reference connectors .21Annex D (informative) Assessment of medi

46、cal devices and their attributes with connections within this application .28Annex E (informative) Summary of the usability requirements for luer connectors for intravascular or hypodermic applications 30Annex F (informative) Summary of luer connector design requirements for intravascular or hypoder

47、mic applications 34Annex G (informative) Summary of assessment of the design of the luer connector for intravascular or hypodermic applications 37Annex H (informative) Reference to the essential principles 40Annex I (informative) Terminology Alphabetized index of defined terms .41Bibliography .42 IS

48、O 2016 All rights reserved iiiContents PageISO 80369-7:2016(E)Foreword ivIntroduction vi1 * Scope . 12 Normative references 13 Terms and definitions . 24 General requirements . 34.1 General requirements for luer connectors 34.2 Material used for luer connectors . 44.3 Type tests . 45 * Dimensional r

49、equirements for luer connectors . 46 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 Sub-atmospheric 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) luer connectors .10Annex C (normative) Reference connectors .21An