DD ENV 12611:1998 PDF

1 Scope This European Prestandard specifies the necessary requirements (clauses  5 , 6 and 7 ) for the categorial structure of systems of concepts for medical device groups (clause  4 ). This prestandard is meant to be used by organizations involved with the development or maintenance of nomenclatures and coding systems for medical devices, and by designers of databases or information systems involving medical devices.