1、ICS 11.100In vitro diagnostic medical devicesSingle-use receptacles for the collection of specimens,other than blood, from humansEnglish version of DIN EN 14254In-vitro-Diagnostika Einmalgefe fr Untersuchungsgut vom Menschen mit Ausnahme von BlutprobenEuropean Standard EN 14254 : 2004 has the status
2、 of a DIN Standard.A comma is used as the decimal marker.National forewordThis standard has been prepared by CEN/TC 140 In vitro diagnostic systems (Secretariat: Germany).The responsible German body involved in its preparation was the Normenausschuss Medizin (MedicalStandards Committee), Technical C
3、ommittee Blutentnahmesysteme und Einmalprobengefe fr dieIn-vitro-Diagnostik.DIN ISO 3696 is the standard corresponding to International Standard EN ISO 3696 referred to in clause 2of the EN.DEUTSCHE NORM September 2004DIN EN 14254 No part of this standard may be reproduced without the prior permissi
4、on ofDIN Deutsches Institut fr Normung e.V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).English price group 12www.din.dewww.beuth.de9598533Continued overleaf.Document comprises 18 pages.01.05G4G15G65G91G39G5English versionICS 11
5、.100In vitro diagnostic medical devicesSingle-use receptacles for the collection of specimens,other than blood, from humans 2004. CEN All rights of exploitation in any form and by any meansreserved worldwide for CEN national members.Ref. No. EN 14254 : 2004 EIn-vitro-Diagnostika Einmalgefe frUntersu
6、chungsgut vom Menschen mitAusnahme von BlutprobenThis European Standard was approved by CEN on 2004-04-23.CEN members are bound to comply with the CEN/CENELEC Internal Regulationswhich stipulate the conditions for giving this European Standard the status of anational standard without any alteration.
7、Up-to-date lists and bibliographical references concerning such national stand-ards may be obtained on application to the Management Centre or to anyCEN member.The European Standards exist in three official versions (English, French, German).A version in any other language made by translation under
8、the responsibility of aCEN member into its own language and notified to the Management Centre hasthe same status as the official versions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, theCzech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,Iceland,
9、 Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands,Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, andthe United Kingdom.EN 14254June 2004Management Centre: rue de Stassart 36, B-1050 BrusselsEuropean Committee for StandardizationComit Europen de Normali
10、sationEuropisches Komitee fr NormungDispositifs mdicaux de diagnostic invitro Rcipients usage unique pourle prlvement des chantillons sur leshumains non sanguinsPage 2EN 14254 : 2004PagePage 3EN 14254 : 2004Page 4EN 14254 : 2004Page 5EN 14254 : 2004Page 6EN 14254 : 2004Page 7EN 14254 : 2004Page 8EN 14254 : 2004Page 9EN 14254 : 2004Page 10EN 14254 : 2004Page 11EN 14254 : 2004Page 12EN 14254 : 2004Page 13EN 14254 : 2004Page 14EN 14254 : 2004Page 15EN 14254 : 2004Page 16EN 14254 : 2004Page 17EN 14254 : 2004
