ENIS0 14630 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM December 2024 ICS 11.040.40 Supersedes EN IS0 14630:2012 English Version Non-active surgical implants - General requirements (IsO 14630:2024) Implants chirurgicaux non actifs - Exigences genérales Nichtaktive chirurgische Implantate - Allgemeine (ISO 14630:2024) Anforderungen (IS0 14630:2024) ThisEuropeanStandardwasapprovedbyCENon17July2024. 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 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. CENmembersarethenational standardsbodies ofAustria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,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 United Kingdom. ces EUROPEAN COMMITTEE FOR STANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels @2024CEN All rights of exploitation in any form and by any means reserved Ref.No.ENISO14630:2024E worldwide for CEN national Members. EN IS0 14630:2024 (E) European foreword This document (EN IS0 14630:2024) has been prepared by Technical Committee IS0/TC 150 "Implants for surgery" in collaboration with Technical Committee CEN/TC 285 "Non-active surgical implants" 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of an identical text or by endorsement, at the latest by June 2025, and conflicting national standards shall be withdrawn at the latest by June 2025.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 14630:2012. This document has been prepared under a standardization request addressed to CEN by the European Commission. The Standing Committee of the EFTA States subsequently approves these requests for its Member States. For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this document. 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 European Standard: Austria, Belgium, Bulgaria, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkiye and the United Kingdom. Endorsement notice The text of IS0 14630:2024 has been approved by CEN as EN IS0 14630:2024 without any modification. EN IS0 14630:2024 (E) Annex ZA (informative) Relationship between this European Standard the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered This European standard has been prepared under M/575 to provide one voluntary means of conforming to the General Safety and Performance Requirements of Regulation (EU) 2017/745 of 5 April 2017 concerning medical devices [0J L 117] and to system or process requirements including those relating to quality management systems, risk management, post-market surveillance systems,