En iso 134852016 standards1/11/2024 On 17 th November 2017, an update to the list of harmonized standards was published in the OJ. An Annex Z for each applicable Directive describes the extent of the presumption of conformance with the regulatory requirement by linking the clauses of the standard with the applicable regulatory requirement. Where the European Standard is an adoption of an international standard, the European Foreword includes a cross-reference table between each normative reference in the international standards and the equivalent European standard. Harmonized European standards include a European Foreword and one or more Annex Z. There have been long delays in getting new and revised standards added to the list of standards harmonized for the Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD). European Commission publishes additions to the list of standards cited in the Official JournalĮuropean standards that are cited in the Official Journal of the European Union (OJ), called harmonized standards, provide a presumption of conformity for the regulatory requirements for which they are cited.
0 Comments
Leave a Reply.AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |