Small-bore connectorsfor liquids and gases inhealthcare applications
Part 3: Connectors for enteral applications(ISO 80369-3:2016)
Nationalforeword
This British Standard is the UK implementation of EN ISO80369-3:2016.
The UK participation in its preparation was entrusted to Technical Committee CH/210/5 Small Bore Connectors for Medical Devices.
A list of organizations represented on this mittee can beobtained on request to its secretary.
provisions of a contract. Users are responsible for its correct This publication does not purport to include allthe necessaryapplication.
Published by BSI Standards Limited 2016 The British Standards Institution 2016.
ISBN 978 0 580 83462 2
ICS 11.040.25
Compliance with a British Standard cannot confer immunity fromlegal obligations.
This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2016.
Amendments/corrigenda issued since publication
Date
Text affected
ICS 11.040.25
English version
Small-boreconnectorsforliquidsandgasesinhealthcare applications-Part3:Connectorsforenteralapplications(ISO 80369-3:2016)
Raccords de petite taille pour liquides et gaz utilisesdestines a des applications enterales (ISO 80369- dans le domaine de la sante - Partie 3: Raccords3:2016)
Verbindungssticke mit kleinem Durchmesser furAnwendungen -Teil 3: Verbinungsstucke fir enterale Flissigkeiten und Gase in medizinischenAnwendungen (ISO 80369-3:2016)
This European Standard was approved by CEN on 25 May 2016.
CEN and CENELEC members are bound to ply with the CEN/CENELEC Internal Regulations which stipulate the conditions forgiving this European Standard the status of a national standard without any alteration. Up-todate lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or toany CEN and CENELEC member.
This European Standard exists in three official versions (English French German). A version in any other language made byManagement Centre has the same status as the official versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical mittees of Austria Belgium Bulgaria Croatia Cyprus Czech Republi Denmark Estonia Finland Former Yugoslav Republic of Macedonia France Germany Greece Hungary Iceland Ireland taly Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain Sweden Switzerland Turkey and United Kingdom.
Europeanforeword
This document (EN ISO 80369-3:2016) has been prepared by Technical Committee ISO/TC 210 "QualityCommittee CEN-CENELEC/TC 3 *Quality management and corresponding general aspects for medical management and corresponding general aspects for medical devices" in collaboration with Technicaldevices* the secretariat of which is held by NEN.
identical text or by endorsement at the latest by February 2017 and conflicting national standardsshall be withdrawn at the latest by February 2017.
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patentrights.
a pue uoss ueadomg a q a o ua ap e apun paedad uaaq seq unop sEuropean 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 thisdocument.
According to the CEN-CENELEC Internal Regulations the national standards organizations of thefollowing 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 Malta 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 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 themeaning 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 state-of-art.
normative reference to the parallel EN standard or dated ISO standard as outlined below including the When the ISO or IEC standard is referred to in the ISO text standard this must be understood as aforeword and the Annexes Z.
NOTE The way in which these references documents are cited in normative requirements determines theextent (in whole or in part) to which they apply.
Table - Correlations between normative references and dated EN and ISo/IEC standards
Normative references as listed in Clause 2 Equivalent dated standardEN ISO/IECISO 5356-1:2004 EN ISO 5356-1:2004 ISO 5356-1:2004ISO 5356-1:2015 ISO 5356-2:2006 EN ISO 5356-1:2015 EN ISO 5356-2:2007 ISO 5356-1:2015 ISO 5356-2:2006ISO 5356-2:2012 EN ISO 5356-2:2012 ISO 5356-2:2012ISO 8185:2007 EN ISO 8185:2009 ISO 8185:2007EN 13544-2:2002 EN 13544-2:2002EN 13544-2:2002A1:2009 EN 13544-2:2002A1:2009ISO 80369-1:2010 EN ISO 80369-1:2010 ISO 80369-1:2010ISO 80369-6:2016 EN ISO 80369-6:2016 ISO 80369-6:2016ISO 80369-7:* EN ISO 80369-7:a ISO 80369-7:-*ISO 80369-20:2015 EN ISO 80369-20:2015 ISO 80369-20:2015ASTM D638-10 ASTM D790-10 一 一To be published.
