BS EN ISO 10555-5:2013 BSl Standards Publication Intravascular catheters - Sterile and single-use catheters Part 5: Over-needle peripheral catheters (ISO 10555-5:2013) bsi. ..making excellence a habit: BRITISH STANDARD BS ENISO10555-5:2013 National foreword This British Standard is the UK implementation of EN ISO 10555-5:2013. It supersedes BS EN ISO 10555-5:1997 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes. A list of organizations represented on this committee can be obtained on request to its secretary This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. @ The British Standards Institution 2013.Published by BSI Standards Limited 2013 ISBN9780580730115 ICS 11.040.25 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on31July2013. Amendments issued sincepublication Date Text affected EUROPEANSTANDARD ENISO10555-5 NORMEEUROPEENNE EUROPAISCHENORM July 2013 ICS 11.040.25 Supersedes EN ISO 10555-5:1997 English Version Intravascularcatheters-$ Sterile and single-use catheters - Part 5:Over-needleperipheralcatheters(iSO10555-5:2013) Catheters intravasculaires - Catheters steriles et non IntravaskulareKatheter -Sterile Katheterzur einmaligen reutilisables -Partie 5: Catheters peripheriques a aiguille Verwendung - Teil 5: Periphere Katheter mit innen interne (ISO 10555-5:2013) liegender Kanule (ISO 10555-5:2013) This European Standard was approved by CEN on 29 May 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of 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 United Kingdom. EUROPEAN COMMITTEEFOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG ManagementCentre:AvenueMarnix17,B-1000Brussels @2013CEN Allrights of exploitation in any form and by any means reserved Ref.No.ENISO 10555-5:2013:E worldwide for CEN national Members. BSENISO10555-5:2013 ENISO10555-5:2013(E) Foreword This document (EN ISO 10555-5:2013)has been prepared by Technical Committee ISO/TC 84"Devices for CEN/TC 205“Non-active medical devices" the secretariat of which is held by DIN. text or by endorsement, at the latest by January 2014, and conflicting national standards shall be withdrawn at the latest by January 2014. This document supersedes ENISO 10555-5:1997. This document has been prepared under a mandate given to CEN by the European Commission and the countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Hungary,Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Endorsementnotice The text of ISO10555-5:2013 has been approved by CEN as EN ISO 10555-5:2013 without anymodification 3 BS EN ISO 10555-5:2013 ENISO10555-5:2013 (E) Annex ZA (informative) RelationshipbetweenthisEuropeanStandardandtheEssential RequirementsofEUDirective93/42/EECamendedbyDirective 2007/47/EEC This European Standard has bee