标准号:DIN-Fachbericht CEN/TR 15133-2005
中文标准名称:术语.医疗装置类的综合术语和代码
英文标准名称:Nomenclature - Collective terms and codes for groups of medical devices; German version CEN/TR 15133:2005
标准类型:C04
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C04
适用范围: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).
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