Small-boreconnectorsfor liquids and gasesin healthcare applications
Part20:Common test methods
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National foreword
ISBN 978 0 580 82893 5
ICS 11.040.25
Amendments issued since publication
Date Text affected
This British Standard is the UK implementation of EN ISO80369-20:2015.
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.
@ The British Standards Institution 2015. Published by BSI Standards Limited 2015
Compliance with a British Standard cannot confer immunity fromlegal obligations.
This British Standard was published under the authority of theStandards Policy and Strategy Committee on 30 June 2015.
ENISO80369-20
ICS 11.040.25
English Version
Small-boreconnectorsforliquidsandgasesinhealthcareapplications-Part20:Common testmethods(ISO80369-20:2015)
Raccords de petite taille pour liquides et gaz utlises dans ledomaine de la sante - Partie 20: Methodes d’essai munes (ISO 80369-20:2015)
Verbindungsstucke mit kleinem Durchmesser furFlussigkeiten und Gase in medizinischen Anwendungen - Teil 20: Allgemeine Prifverfahren (ISO 80369-20:2015)
This European Standard was approved by CEN on 5 March 2015.
this European Standard the stafus of a national standard without any aleration. Up-o-date Ists and biblographical references concerning CEN and CENELEC members are bound to ply with the CEN/CENELEC Intemal Regulations which sipulate the condions for givingsuch 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 undertheresponsibityfa CENandCENELECmemberinis w languageand noifed to the CEN-CENELEC Management Cetrehas the same status as the oficial versions.
CEN and CENELEC members are the national standards bodies and national electrotechnical mitees of Austria Belgium Bulgaria Croatia Cyprus Czech Republi Denmark Estonia Finland Fomer Yugoslav Republic of Macedonia France Germany GreeceHungary lceland Ireland taly Latvia Lithuania Luxembourg Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain Sweden Switzerland Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATIONEUROPAISCHES KOMITEE FUR NORMUNG
CEN-CENELEC Management Centre: Avenue Mamix 17 B-1000 Brussels
Foreword
This document (EN ISO 80369-20:2015) has been prepared by Technical Committee ISO/TC 210 *Qualitymanagement and corresponding general aspects for medical devices* in collaboration with Technicalsecretariat of which is held by NEN.
This European Standard shall be given the status of a national standard either by publication of an identicaltext or by endorsement at the latest by November 2015 and conficting national standards shallbe withdrawn at the latest by November 2015.
According to the CEN-CENELEC Internal Regulations the national standards organizations of the followingcountries 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 lceland Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Noway Poland Portugal Romania Slovakia Slovenia Spain Sweden Switzerland Turkey and the United Kingdom.
Endorsement notice
modification. The text of ISO 80369-20:2015 has been approved by CEN as EN ISO 80369-20:2015 without any
(informative) AnnexZA
RelationshipbetweenthispartofENISO80369andtheessential requirementsofEUDirective93/42/EEC
ss uedon e e un dd su i jo ed sNew Approach Directive 93/42/EEC Council Directive of 14 June 1993 on the approximation of the laws of the member states concerning medical devices* (Medical Device Directive).
Once this part of EN ISO 80369 is cited in the Official Journal of the European Union under that directive andhas been implemented as a national standard in at least one member state pliance with the clauses ofthis document given in Table ZA.1 confers within the limits of the scope of this part of EN ISO 80369 a presumption of conformity with the corresponding essential requirements of that directive and associatedEFTA regulations.
Table ZA.1- Correspondence between this part of EN ISO 80369 and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essentialrequirements(ERs)of Qualifying remarks/notespart of EN ISO 80369 EU Directive 93/42/EEC4 Annex B Annex C 4 Annex D 7.5 7.64 Annex F Annex G Annex H 9.1Annex 14 Annex E 12.7.14 12.7.4
scope of this part of EN ISO 80369.
in accordance with Directive 93/42/EEC Article 3 the following Table ZA.2 details the relevant essential For devices which are also machinery within the meaning of Directive 2006/42/EC on Machinery Article 2(a) health and safety requirements of Directive 2006/42/EC on Machinery to the extent to which they are moreTable ZA.2 however does not imply any citation in the OJEU under the machinery directive and thus doesnot provide presumption of conformity for the machinery directive.
Table ZA.2-Relevant Essential Health and Safety Requirements (EHSRs) from Directive 2006/42/ECon machinery that are addressed by this document
Clause(s)/sub-clause(s) of this part of EN ISO 80369 EHSR of 2006/42/EC Qualifying remarks/notes4 1.5.4
