標準號：DIN-Fachbericht CEN/TR 15133-2005
中文標準名稱：術語.醫療裝置類的綜合術語和代碼
英文標準名稱：Nomenclature - Collective terms and codes for groups of medical devices; German version CEN/TR 15133:2005
標準類型：C04
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C04
適用范圍：Development of a list of collective terms based on the identified principles to be used, for example, as follows: - to illustrate the scope of certificates issued by Notified Bodies when assessing which groups, families, types of medical devices are covered within a manufacturers quality system, - to be used to identify the range of skills and general technological abilities for which a Notified body has been approved, and is so appointed by the relevant Competent Authority and - for the exchanges of information between Competent Authorities when general information on individual manufacturers capabilities is notified for inclusion in the European Database for Medical Devices (EUDAMED).