EN ISO8536-13 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHENORM September 2024 ICS11.040.20 Supersedes EN ISO 8536-13:2016 English Version Infusion equipment for medical use -Part 13:Graduated flow regulators for single use with fluid contact (ISO 8536. 13:2024) Materiel de perfusion a usage medical-Partie 13: Infusionsgerate zur medizinischen Verwendung-Teil Regulateurs de debit gradues non réutilisables avec 13:Graduierte Durchflussregler zur einmaligen contact a fluide(ISO 8536-13:2024) Verwendung mit Flissigkeitskontakt (ISO 8536- 13:2024) This European Standard was approved by CEN on 20 September 2024. 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 standards maybe obtained on application to the CEN-CENELEC Management Centre or toany CEN member This European Standard exists in three official versions (English,French,German).A version in any other language made by translation under the responsibilityof a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status asthe official versions. CEN members are the national standards bodies of Austria,Belgium,Bulgaria,Croatia,Cyprus,Czech Republic,Denmark,Estonia, Finland,France,Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway, Poland,Portugal,Republicof NorthMacedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,Turkiyeand United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELEC Management Centre:Rue de la Science 23,B-1040 Brussels @2024 CEN All rights of exploitation in any form and by any means reserved Ref.No.EN ISO 8536-13:2024 E worldwide for CEN national Members. EN ISO 8536-13:2024(E) Contents Page European foreword. .3 2 EN IS08536-13:2024 (E) European foreword This document (EN ISO 8536-13:2024)has been prepared by Technical Committee ISO/TC 76 "Transfusion,infusion and injection,and blood processing equipment for medical and pharmaceutical use"in collaboration with Technical Committee CEN/TC 205"Non-active medical devices"the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard,either by publication of an identical text or by endorsement,at the latest by March 2025,and conflicting national standards shall be withdrawn at the latest by March 2025. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.CEN shall not be held responsible for identifying anyor all such patent rights This document supersedes EN ISO 8536-13:2016. Any feedback and questions on this document should be directed to the users'national standards body/national committee.A complete listing of these bodies can be found on the CEN website. According to the CEN-CENELEC Internal Regulations,the national standards organizations of the following countries are bound to implement this EuropeanStandard:Austria,Belgium,Bulgaria, Croatia,Cyprus,Czech Republic,Denmark,Estonia,Finland,France,Germany,Greece,Hungary,Iceland, Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal,Republic of North Macedonia,Romania,Serbia,Slovakia,Slovenia,Spain,Sweden,Switzerland,Tirkiye and the United Kingdom. Endorsement notice modification