EN IS0 7199 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM September2024 ICS 11.040.40 Supersedes EN IS0 7199:2017 English Version Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (Is0 7199:2024) Implants cardiovasculaires et organes artificiels Kardiovaskulare Implantate und kunstliche Organe Echangeurs gaz/sang (oxygenateurs) (IS0 7199:2024) Blut-Gas-Austauscher (0xygenatoren) (IS0 7199:2024) This European Standard was approved by CEN on 10 August 2024. European Standard the status ofa national 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, 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, Turkiye and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG CEN-CENELEC Management Centre: Rue dela Science 23, B-1040 Brussels @2024CEN All rights of exploitation in any form and by any means reserved Ref. No.EN ISO 7199:2024 E worldwide for CEN national Members. EN IS0 7199:2024 (E) Contents Page 2 ENIS0 7199:2024 (E) European foreword This document (EN IS0 7199:2024) has been prepared by Technical Committee IS0/TC 150 "Implants for surgery" 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of an identical text or by endorsement, at the latest by March 2025, and conflicting national standards shall be withdrawn at thelatestby March 2025.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 any or all such patent rights. This document supersedes EN IS0 7199:2017. Any feedback and questions on this document should be directed to the users' national standards body/national committee.A complete listing ofthesebodies can befound on the CEN website. 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, North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkiye and the United Kingdom. Endorsement notice ThetextofIS07199:2024hasbeenapprovedbyCENasENIS07199:2024withoutanymodification 3