DIN EN ISO 14155-1:2009-11

This International Standard is intended to be applied worldwide to clinical investigations of medical devices in order to fulfil the technical aspects of the various national, regional and international regulatory requirements. As the legal regulatory requirements presently differ throughout the world it is necessary to exclude regulatory specifics from the scope of this International Standard. They are part of national or regional legislative texts and can be referenced in the national or regional forewords, as appropriate.