Additional symbols (not previously included in EN 980) are introduced via EN ISO 15223-1. While many of the symbols in EN 980 were largely in ISO 15223-1:2007/Amd 1:2008, both standards are now one international standard and the EN 980 EC REP symbol designating Authorized Representative has been added to EN ISO 15223-1. When EN 980:2008 is officially withdrawn on 31 January, 2013, the European Norm standard will be superseded by EN ISO 15223-1:2012. Moreover, two of the most important standards for manufacturers in the European Community, ISO 13485 and ISO 14971, will see updated versions published. Notably, the 2012 version of EN ISO 15223-1 will replace EN 980 as the recognized standard for symbols to be used in medical device labeling. A snapshot document published by the European Committee for Standardization (CEN) presents the latest on forthcoming standards that will be harmonized to the three EU medical devices directives. We note that there is considerable change in the world of harmonized standards. Big changes in the world of EU harmonized standards
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |