BSENIS020696:2018 BSI Standards Publication Sterile urethral catheters for single use (Is0 20696:2018) bsi. BSENIS020696:2018 EN IS0 20696 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM July2018 ICS11.040.25 Supersedes EN 1616:1997 English Version Sterile urethral catheters for single use (IS0 20696:2018) Sondes urinaires steriles non reutilisables (Iso Sterile Harnblasenkatheter zur einmaligen 20696:2018) Verwendung (IS0 20696:2018) This European Standard was approved by CEN on 5 May 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of anational standard without any alteration.Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEENDENORMALISATION EUROPAISCHESKOMITEEFUR NORMUNG CEN-CENELEC Management Centre: Rue dela Science23, B-1040Brussels 2018CEN All rights ofexploitation in any formand by any means reserved Ref.No.ENISO20696:2018E worldwide for CEN national Members. BSENIS020696:2018 EN IS0 20696:2018 (E) European foreword This document (ENIS020696:2018)has beenprepared byTechnical CommitteeIS0/TC 84"Devices for administration of medicinal products and catheters"in collaboration with Technical Committee CEN/TC 205"Non-active medical devices"the secretariat of which is held byDIN. This European Standard shall be given the status of a national standard, either by publication of an identical textorby endorsement,atthelatestbyJanuary2o19,andconflictingnationalstandardsshall bewithdrawnatthelatestbyJanuary2019 Attention is drawntothepossibilitythat someof theelements of this documentmaybethe subject of patent rights.CEN shall not be held responsible for identifying any or all such patent rights. ThisdocumentsupersedesEN1616:1997. According to the CEN-CENELEC Internal Regulations,the national standards organizations of the following 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, Serbia, Slovakia, Slovenia, Spain,Sweden, Switzerland, Turkey and the United Kingdom. Endorsementnotice ThetextofIS020696:2018hasbeenapprovedbyCENasENIS020696:2018withoutanymodification. 3