Small-bore connectors for liquids and gases in healthcare applications
Part 7: Connectors for intravascular or hypodermic applications
bsi.
Nationalforeword
This BritishStandard is the UK implementation of EN ISO 80369-7:2017.It is identical to ISO 80369-7:2016. It supersedes BS EN 20549-1:1994 andBS EN1707:1997which arewithdrawn.
CommitteeCH/210/5 SmallBoreConnectorsforMedicalDevices.
A list of organizations represented on this mittee can be obtained onrequest to its secretary.
This publication does not purport to include all the necessary provisionsof a contract. Users are responsible for its correct application.
TheBritishStandardsInstitution2017Published by BSI Standards Limited 2017
ISBN9780580771675
ICS 11.040.25
CompliancewithaBritishStandardcannotconferimmunityfromlegal obligations.
This BritishStandard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2017.
Amendments/corrigendaissuedsincepublication
Date
Textaffected
EN ISO 80369-7
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 taillepour liquides et gazutilisesdansle domaine dela santé-Partie7:Raccords a 6% (Luer) destines aux applications intravasculairesouhypodermiques (ISO 80369-7:2016)
Verbindungssticke mit kleinem DurchmesserfurFlussigkeiten und Gasein medizinischenAnwendungen-Teil 7:Verbindungsstucke mit einem 6%(Luer) Kegel furintravaskulare oderhypodermischeAnwendungen(ISO80369-7:2016)
This European Standard was approved by CEN on 21 May 2017.
conditions forgiving this European Standard the status of a national standard without any alteration.Up-to-datelistsand bibliographical referencesconcerning such national standardsmay be obtained on application to the CEN-CENELECManagement Centre orto any CEN and CENELECmember.
This European Standard exists in three official versions (English French German).A version in any other language madeCENELECManagement Centre has thesame status as the officialversions.
CENand CENELECmembersare thenationalstandardsbodiesandnationalelectrotechnical mitteesofAustria Belgium Bulgaria Croatia Cypru zechRepublic Denmark Estonia Finland FormerYugoslavRepublicofMacedonia France Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey and United Kingdom.
CEN-CENELECManagementCentre:AvenueMarnix17 B-1000Brussels
Europeanforeword
The text of ISO 80369-7:2016 has been prepared by Technical Committee ISO/TC 210“Qualitymanagement and corresponding general aspects for medical devices"of theInternational OrganizationforStandardization(ISO)andhasbeentakenoverasENISO80369-7:2017byTechnicalCommitteeCEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices" thesecretariatofwhichisheldbyNEN.
This European Standard shall be given the status of a national standard either by publication of anidentical text orby endorsement atthe latest by November 2017 and conflicting national standardsshallbewithdrawnatthelatestbyMay2020.
Attentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectof patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all suchpatent rights.
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 theEuropeanFree Trade Association and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s) see informative Annex ZA which is an integral part ofthis document.
According to the CEN-CENELEC Internal Regulations the national standards organizations of thefollowingcountries arebound toimplementthisEuropeanStandard:Austria Belgium Bulgaria Croatia Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey andtheUnited Kingdom.
Thefollowingreferenced documentsareindispensableforthe applicationofthisdocument.Forundatedreferences the latestedition ofthe referenced document(including any amendments) applies.For datedreferences only the edition cited applies. However for any use of this standard“within the meaning ofAnnex ZA" the user should always check that any referenced document has not been superseded andthat its relevant contents can still beconsidered the generally acknowledged state-of-art.
When theISOorIECstandard isreferredtointheISOtextstandard thismustbeunderstood as anormativereferencetotheparallelENstandardordatedISOstandard asoutlinedbelow includingtheforeword and theAnnexesZZ.
NOTE Thewayinwhichthesereferences documentsarecitedinnormativerequirementsdeterminestheextent(inwhole orinpart) towhich they apply.
Table-CorrelationsbetweennormativereferencesanddatedENandIso/IECstandards
Normativereferencesaslistedin EquivalentdatedstandardClause2 EN ISO/IECISO14971:2007 ENISO 14971:2012 ISO14971:2007ISO5356-1:2004 EN5356-1:2004 ISO5356-1:2004ISO5356-1:2015 EN5356-1:2015 ISO5356-1:2015ISO 5356-2:2006 EN 5356-2:2007 ISO5356-2:2006ISO5356-2:2006 EN 5356-2:2007 ISO5356-2:2006EN 5356-2:2012 ISO 5356-2:2012ISO5356-2:2012ISO8185:2007 EN 8185:2009 ISO8185:2007EN 13544-2:2002 EN 13544-2:2002 一EN13544-2:2002A1:2009 EN 13544-2:2002A1:2009ISO 80369-1:2010 EN ISO80369-1:2010 ISO 80369-1:2010ISO80369-3:2015 ENISO 80369-3:2016 ISO 80369-3:2015ISO80369-6:2015 ENISO80369-6:2016 ISO80369-6:2015ISO 80369-20:2015 EN 80369-20:2015 ISO 80369-20:2015ASTM D638-10ASTMD790-10
Endorsement notice
The text of ISO 80369-7:2016 has been approved by CEN as EN ISO 80369-7:2017 without anymodification.
