Smallboreconnectorsfor liquids and gasesin healthcare applications
Part 1:General requirements (ISO80369-1:2010)
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National foreword
BSI 2011
ISBN 978 0 580 60941 1
ICS 11.040.10; 11.040.20
Amendments issued since publication
Date Text affected
This British Standard is the UK implementation of EN ISO80369-1:2010. It supersedes BS EN 15546-1:2008 which is withdrawn.
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.
This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correctapplication.
Compliance with a British Standard cannot confer immunity from legal obligations.
This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2011.
ENISO80369-1
ICS 11.040.10; 11.040.20
Supersedes EN 15546-1:2008
English version
applications-Part 1:Generalrequirements(ISO80369-1:2010) Small boreconnectorsforliquidsandgasesinhealthcare
Raccords de petite taille pour fiquides et gaz utilises dansle domaine de la sante - Partie 1: Exigences generales (ISO 80369-1:2010)
Verbindungssticke mit kleinem Durchmesser fuirFlissigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010)
This European Standard was approved by CEN on 14 December 2010.
this European Standard the status of a national standard without any alleration.Up-to-date lists and biblographical references concerning CEN and CENELEC members are bound to ply with the CEN/CENELEC Internal Regulations which stipulate the condions for giving such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELECmember.
This European Standard exists in three oficial versions (English French German). A version in any other language made by translation under the responsibilty of a CEN and CENELEC memberinto is own language and notifed to the CEN-CENELEC Management Centrehas 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 Republic Denmark Estonia Finland France Germany Greece Hungary lceland Ireland Italy Latvia Lithuania Kingdom. Luxembourg Mata Netherlands Nonway Poland Portugal Romania Slovakia Slovenia Spain Sweden Switzerland and United
Avenue Marnix 17 B-1000 Brussels CENELEC Central Secretariat:
Avenue Marnix 17 B-1000 Brussels CEN Management Centre:
Foreword
management and corresponding general aspects for medical devices* in collaboration with Technical This document (EN ISO 80369-1:2010) has been prepared by Technical Committee ISO/TC 210 *QualityCommittee CEN/CLC/TC 3 *Quality management and corresponding general aspects for medical devices" the secretariat of which is held by NEN.
the latest by June 2011.
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 June 2011 and conflicting national standards shall be withdrawn at
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 supersedes EN 15546-1:2008.
European Free Trade Association and supports essential requirements of EU Directive. This document has been prepared under a mandate given to CEN by the European Commission and the
For relationship with EU Directive see informative Annex ZA which is an integral part of this document.
Compared to EN 15546-1:2008 the following changes were implemented:
a) Clause 3 “Terms and definitions* has been editorially revised and amended by the terms “accessory” “breathing system" “non-interconnectable” *patient” and “responsible organization”. The terms "risk” and"safety" have been cancelled and replaced by a general reference to the appropriate terms given in ENISO 14971 and IEC 62366;b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity; inpatibility;d) A new Clause 6 on additional applications has been added;e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has beeninitiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3)have been stated more detailed;In addition the Table A.1 on risk analysis of possible misconnections has been cancelled;g) A new Annex B *Mechanical tests for verifying non-interconnectable characteristics* has been added;h) Annex C "Applications* (respectively Clause B in EN 15546-1) has been editorially revised;i) Annex C “Small bore connectors for vascular systems applications" of EN 15546-1 has been cancelled;j) A new Annex D *Reference to the Essential Principles" according ISO/TR 16142 has been added;k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been aligned;I) The Bibliography has been updated and amended;
m) A new clause Terminology has been added at the end of the standard;
n) Editorial revision in alignment with the overtaking of the original European Standard into an International Standard.
Lithuania Luxembourg. Malta Netherlands Norway Poland Portugal Romania Slovakia Slovenia Spain Sweden Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any modification.
